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3.0 - 5.0 years
5 - 7 Lacs
Bengaluru
Work from Office
for Risk & Compliance New Associate Position Title:Risk & Compliance New Associate CL -13 Location: Bengaluru Employment Type: Full Time Must have skills : Risk & Compliance Good to have skills : Compliance About CF/S&C Corporate Functions include Human Resources, Finance, Legal, Marketing Communications, and Workplace Solutionsthat power Accenture's people across industries and functions to keep our business leading in the New. Join the heart and soul of Accenture, partnering with our extraordinary people to bring innovation into every organization. Combining unmatched experience and specialized skills across more than 40 industries, the company offers Strategy and Consulting, Song (Interactive), Technology and Operations servicesall powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. With net revenues of $64 billion for 2023, their 774,000+ employees deliver on the promise of technology and human ingenuity every day, serving clients in more than 49 countries and over 200 cities. Job Summary : The Risk & Compliance Manager is responsible for identifying, assessing, and mitigating potential organizational risks. They develop and implement risk management plans and ensure the organization complies with relevant laws, regulations, and internal policies. Roles & Responsibilities: Good Communication skills Candidate should have good excel skills. Adaptable and flexible Maintain and update compliance calendar, trackers, periodical reports, and repositories. Knowledge of labour Laws Strong analytical and problem-solving skills. Attention to detail and ability to work independently. Familiarity with regulatory requirements and compliance standards. Monitor and report on compliance issues and risks. Job Qualification: Additional Information: - The ideal candidate will possess a strong educational background in Law or a related field, along with good knowledge and experience in relevant country compliance. This position is based at our Bengaluru office. Qualification Experience: Minimum 1 - 2 year(s) of experience is required Educational Qualification: LLB
Posted 1 week ago
3.0 - 8.0 years
3 - 6 Lacs
Pune
Work from Office
At OneStudyTeam (a Reify Health company), we specialize in speeding up clinical trials and increasing the chance of new therapies being approved with the ultimate goal of improving patient outcomes. Our cloud-based platform, StudyTeam, brings research site workflows online and enables sites, sponsors, and other key stakeholders to work together more effectively. StudyTeam is trusted by the largest global biopharmaceutical companies, used in over 6,000 research sites, and is available in over 100 countries. Join us in our mission to advance clinical research and improve patient care. One mission. One team. That s OneStudyTeam. As a Specialist, Source Configuration on our Trial Design team, you will have the important responsibility of ensuring that clinical research professionals effectively and correctly collect, manage, and safeguard the very source data that demonstrate whether an investigational product is safe and effective. In streamlining our source configuration and administration process to ensure top-notch implementation of our products, you will have an impact on making clinical trials more efficient and cost effective, thereby reducing clinical research as a bottleneck that constrains the availability of new life-enhancing and life-saving treatments. Your clinical research experience, attention to detail, and ability to troubleshoot issues will be key as you work independently to build, test, and publish electronic forms while meeting tight deadlines for multiple projects. This role offers the opportunity for the responsibilities to expand and develop with the organizations needs What You ll Be Working On Learn and maintain deep expertise in StudyTeam applications Review research protocols, CRF guidelines, and other stakeholder specifications to create accurate, comprehensive source form (CRF) templates Conduct and document thorough QA of source form templates Develop electronic forms, using Excel, from stakeholder specifications and feedback Build, test, and publish electronic source forms to maintain quality of the form design Support and coordinate user acceptance testing Collaborate with cross-functional teams to ensure successful execution of projects and provide feedback on product improvements to enhance our eSource product capabilities Help refine, document, and implement best practices for standardization, QA, and process improvement around source form creation and digitization What You Bring to OneStudyTeam 3+ years of relevant clinical research experience, including experience creating and/or QAing source document templates (CRFs) BA or BS, degree in business, science or related field, or AA degree and/or commensurate experience in relevant field(s) Prior experience owning successful execution of projects across teams, driving collaboration and successful completion, beyond an individual contributor status Experience working directly with clients (internal and/or external) and championing their long-term success Proven experience researching, learning, and utilizing new technologies and software Prior experience with a CTMS or other clinical research software tool is preferred Excellent communication (written and verbal), collaboration, and presentation skills Ability to thrive in a fast-paced, start-up environment - you are comfortable with ambiguity and find no job too big or small Extensive experience working with Excel Excellent organizational skills, attention to detail, and critical and creative problem solving skills Solution-oriented thinking, a zest for learning, and a willingness to help whenever needed Excellent time managements skills and the ability to prioritize multiple workloads Familiarity with CLI (Command-Line Interface) is a plus Experience with Python programming and GUI development (using Visual Studio Code) is a plus Business-level fluency in English We value diversity and believe the unique contributions each of us brings drives our success. We do not discriminate on the basis of race, sex, religion, color, national origin, gender identity, age, marital status, veteran status, or disability status. Note : OneStudyTeam is unable to sponsor work visas at this time. If you are a non-U.S. resident applicant, please note that OneStudyTeam works with a Professional Employer Organization. As a condition of employment, you will abide by all organizational security and privacy policies. This organization participates in E-Verify (E-Verifys Right to Work guidance can be found here ).
Posted 1 week ago
6.0 - 9.0 years
15 - 20 Lacs
Hyderabad
Work from Office
Challenging. Meaningful. Life-changing. Those aren t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers. bms. com/working-with-us . Associate Manager, Clinical Data Management Responsibilities will include, but are not limited to: Study Startup: Draft EDC build timeline in collaboration with Data Management Lead. Perform DB build tasks by creating specifications for Database and Edit Checks. Create test scripts and complete test data entry/UAT for Coding, Site Payment, Safety Gateway. Collaborate with Data Management Lead and facilitate startup meetings which includes, not limited to, EDC build kick-off, Interactive eCRF Build and IRMs (Interactive Review Meeting) for database and Edit checks. Create and finalize study documents like Data Quality Management Plan, eCRF completion Instructions, Protocol Data Review Plan (PDRP) post study team review. Ensure all startup documents are completed as per SOP and filled in eTMF as per eTMF master plan. Study Conduct: Plan/execute Post Production/Migration for the study (if any). Coordinate with Clinical Data Managers for the execution of data review tasks. Coordidate with external data vendors for any escalations related to any vendor data. Support Clean Patient Group delivery along with Clinical Data Management staff. Update study documents as needed during the conduct of the study Support DML to coduct Data Quality Review meetings. Provide Data Health Metrics to Data Management Lead as requested. Study Closeout- Support Data Management Lead in planning and execution of database lock activities. Perform post lock activities, as needed. Project Management Support DML in project management tasks to make sure that study is delivered successfully as per the study timelines with quality. Documentation: Filing of appropriate documents in eTMF as per eTMF master plan. Training and Mentorship: Provide Training and mentoring to junior CDM staff. Bachelor s Degree required. Life sciences, Pharmacy or relevant fields preferred. 6 years of experience in managing end to end Clinical Data Management tasks. Able to work on end to end Clinical Data Management tasks Able to work collaboratively on multi-disciplinary project teams. Strong knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management Strong knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills. Strong oral and written communication skills. Strong project management skills
Posted 1 week ago
3.0 - 4.0 years
15 - 20 Lacs
Hyderabad
Work from Office
Challenging. Meaningful. Life-changing. Those aren t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers. bms. com/working-with-us . Position Summary We are seeking a candidate with knowledge of clinical trials and the end-to-end management of biospecimens. You will be an independent contributor who will work closely with our Clinical Teams to develop and implement biospecimen management plan for BMS-sponsored Phase 1-4 clinical trials. Critical to this role is the ability to oversee timelines for specimen data delivery and thereby, enabling quick decision-making and ensuring BMS s continuous competitive advantage. Key Responsibilities Oversee and manage the complete lifecycle of biospecimens collected for clinical studies with minimal supervision. Clinical Team member responsible for providing shipping/sample movement and management including requests, query and inventory reports, follow up active issues with vendors, prepare sample management related reports, review/prepare tracking activities (such as vendor manifests/inventories, tissue/blood match pairing, depleted/non-viable samples, loading documents to Shared Drive folders, etc. ). Independently reviews clinical study protocol providing comparison of vendor statement of work and biospecimen relevant sections and feedback with support as needed. Performs routine vendor management responsibilities. Able to request and/or access necessary vendor/system inventory files to perform specimen tracking. Able, under direction, to create biospecimen tracker using various tracking tools (MS Excel, Spotfire, Tableau or internal systems (if applicable)). Exercises judgment within policy and procedure boundaries. Troubleshoots routine problems and understands when appropriate to ask for guidance. Qualifications & Experience Minimum of 3-4 years academic, biotech, healthcare or pharmaceutical industry experience or equivalent. Basic understanding of clinical and biomedical research, GCP, GLP, CLIA, data management, risk management and regulatory issues. Demonstrated clinical trial experience, healthcare/medical/laboratory or equivalent. Vendor experience preferred (e. g. , Central Labs, Bioanalytical, Biomarker, CROs, Biospecimen Storage Vendors, etc. ). Biospecimen management experience preferred but not mandatory. Ability to effectively communicate, create and deliver presentation/information/data to knowledgeable audiences, with limited supervision. Ability to adopt a biopharma enterprise-wide and entrepreneurial mindset, to act with a sense of urgency, accountability and integrity, and to have fun along the way. Travel requirement is minimal, 0%- 5% of time, when organization requests If you come across a role that intrigues you but doesn t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. With a single vision as inspiring as Transforming patients lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms. com . Visit careers. bms. com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers. bms. com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Posted 1 week ago
8.0 - 13.0 years
10 - 20 Lacs
Hyderabad
Work from Office
Role & responsibilities Primary responsibilities 1. Medical monitoring of the in-house clinical trials and overseeing of CRO medical monitoring of outsourced projects. 2. Development and review clinical documents including protocol, investigator's brochure, case record form, product rationale, prescribing information, drug interactions etc 3. Organization of Subject Expert Committee meeting materials and attending SEC meetings for clinical trials and marketing approvals Secondary responsibilities 1. Medical Review of ICSRs, Aggregate reports, Signal reports and Risk Management plans 2. Review of clinical and non-clinical overviews and summaries of CTD 3. Review of medical rationale for CT waiver applications 4. New products evaluation for development 5. Develop, review and approve marketing requests of product evaluations, comparative safety and efficacy training material 6. Mentoring/ training team members to gain required skills to enable on-time deliverables. Required Educational Qualification: MBBS and/or MD (Pharmacology) Work Exp.: MBBS with 10-12 years of experience [OR] MD (Pharmacology) 8-10 years of experience Mandatory Skills Required: Clinical Trails, Protocol Writing, Medical Writing, Investigatioons
Posted 1 week ago
1.0 - 4.0 years
6 - 13 Lacs
Hyderabad
Work from Office
Role & responsibilities : Key Responsibilities Conduct medical review of study related documents Prepare high quality medical rationale documents for agency submission Periodic Safety review Medical monitoring Develop clinical rationale for new products. Competencies and exposure to succeed in the role. Previous experience in medical review of clinical study documents (trial and BA/BE). Knowledge of clinical development for different regulatory such as USFDA, IND, EMA, JFDA. Familiarity with medical coding dictionaries (e.g., MedDRA) and safety reporting Strong attention to detail and ability to work with complex medical data. Effective communication and interpersonal skills to collaborate with cross-functional teams and stakeholders. Preferred candidate profile
Posted 1 week ago
1.0 - 6.0 years
3 - 8 Lacs
Bengaluru
Work from Office
Analysts engage in risk, compliance, and financial crimes projects to serve Promontory clients within the banking and finance industry – helping them meet and exceed regulatory expectations. Analysts are expected to positively contribute to Promontory’s success in a variety of areas, including BSA, anti-money laundering surveillance and reporting assistance, OFAC sanctions compliance, and other areas relevant to today’s heightened regulatory climate. Analysts must possess excellent writing, research, analytical, and critical thinking skills, and other applicable experience that leads to success in the role, such as strong work ethic and natural curiosity. Analysts must be able to judiciously analyze, assess, and write clearly and concisely. The nature of this work requires individuals to be flexible, learn new skills, work within time constraints, and meet uncompromising quality requirements and production expectations while working closely with others in a dynamic team environment. Apply logic and strong reasoning skills to conduct research for case analysis. Use sound decision-making skills to make recommendations based on research results. Compose comprehensive supporting narratives Interpret and apply project policies and procedures to direct work. Maintain high work product quality as outlined by each project specifications. Ensure work adheres to defined engagement policies and procedures Manage work efficiently to meet production goals and project deliverables. Contribute to developing individual and project goals and execute on tactical strategies for goal attainment. Required education Bachelor's Degree Preferred education Master's Degree Required technical and professional expertise 1+ year prior AML experience REQUIRED. Compliance experience at a financial institution is STRONGLY PREFERRED. Retail banking experience is PREFERRED. The ability to work independently, take initiative, and able to adapt to change. Ability to quickly understand and maintain current know3ledge of banking regulations, concepts, and issues. Quickly learn new applications and client systems to conduct research. Exercise sound judgment and observe the highest degree of confidentiality. Adept at multi-tasking and meeting deadlines in high-pressure environment. Results oriented team player with strong initiative and flexibility. Strong analytical and problem-solving abilities. Superior writing skills with the ability to convey ideas clearly and succinctly. Exemplary customer service towards both internal and external parties.
Posted 1 week ago
3.0 - 5.0 years
5 Lacs
Chennai
Work from Office
Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Specialist Qualifications: MBBS/MD Years of Experience: 3 to 5 years Language - Ability: English(International) - Proficient About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Performs Medical Assessment activities related to drug safety Pharmacovigilance for the Individual Case Safety Reports- Responsible to perform Medical Review of ICSRs according to the client SOPs/Manuals- Prioritizes the cases according to Regulatory clock date, Seriousness criteria and ensure the cases are completed according to the timelines mentioned in client SOP- Performs review of all applicable Medical Review Fields and ensures accuracy - Plan, organize and manage daily work to meet the service level timelines and deliverables- Review MedDRA coding of reported terms in Cases, suggest additional events to be added wherever necessary - Causality assessment of serious cases and relevant non-serious cases with Company Remarks wherever applicable- Performs labelling of events of applicable cases- Provides Medical Expertise to case processing team whenever required- Provides training/mentoring to the team members wherever applicableCreate and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Understanding of PharmacovigialnceExperience in Medical Review of ICSRsMedical Review Roles and Responsibilities: - Responsible to perform Medical Review of ICSRs according to the client SOPs/Manuals- Prioritizes the cases according to Regulatory clock date, Seriousness criteria and ensure the cases are completed according to the timelines mentioned in client SOP- Performs review of all applicable Medical Review Fields and ensures accuracy - Plan, organize and manage daily work to meet the service level timelines and deliverables- Review MedDRA coding of reported terms in Cases, suggest additional events to be added wherever necessary - Causality assessment of serious cases and relevant non-serious cases with Company Remarks wherever applicable- Performs labelling of events of applicable cases- Provides Medical Expertise to case processing team whenever required- Provides training/mentoring to the team members wherever applicable Qualification MBBS,MD
Posted 1 week ago
4.0 - 8.0 years
11 - 18 Lacs
Hyderabad
Work from Office
Works with a team of Medical regulatory writers with different levels of expertise, Develops medical expertise within Medical regulatory writing (on contents, methods, and processes). Ensures compliance with regulatory requirements from various regions (FDA, EU others) for activities supported. Coordinates and supports medical activities related to the maintenance of the marketing authorizations of Established and Generic products, in different therapeutic areas. Works in close collaboration with Global Medical Leads, Global Regulatory Affairs, Global Pharmacovigilance, and vendors Essential Job duties and responsibilities: Responsible to provide a medical assessment with relevant and updated clinical evidence and monitoring the execution of strategic documents such as PBRERs, ACOs, DSURs, Clinical Overviews, Benefit-Risk assessments, Expert statements for MDD, Responses to Health Authority Queries, Ad-hoc literature analyses, and labeling documents for the corresponding therapeutic area or products or any other activities which are the core activities of GMLs. Drafting the extended synopsis of studies in collaboration with RWE experts. He/she will be responsible for overseeing the execution of such plans by the respective operational units in compliance with SOP, GCP, and other regulations. Writing of Key medical/clinical parts of Common Technical Documents (CTD) or Briefing packages (BP). Reviewing and approving compassionate use of individual medical requests for use of Sanofi medicinal products for serious or life-threatening diseases for treatment outside of clinical trials. Secure delivery of high-quality medical documents on time and in compliance with internal and external standards. Collaborates effectively with stakeholders: global medical leads/ medical product leads, global regulatory affairs, medical regulatory writing global or local teams, pharmacovigilance teams, managed access program teams. People: Maintain effective relationships with the end stakeholders (Medical, regulatory, pharmacovigilance community) within the allocated Global business unit and product with an end objective to develop medical regulatory content as per requirement, 2) Interact effectively with stakeholders in medical and pharmacovigilance departments 3) Constantly assist the medical regulatory writing team in developing knowledge and sharing expertise Performance: Secure deliverables (PBRER, ACO, SO, CSR, ID Cards, Investigator brochure, clinical evaluation report, briefing packages, medical section of CTA, CTD, SBRAs, MDD, HAQs or any other activities which are core activities for GMLs) are supported as per agreed timelines and quality Process: Provide medical strategic insights & evaluation related to Company's portfolio. Contribute to the management of the marketing authorization dossiers of the current related portfolio. Act as an expert in the field of medical regulatory writing and maintain the regulatory requirement for countries, and teams supported. Assist the assigned medical team in conducting comprehensive medical regulatory writing-needs analysis Implement relevant elements of the medical regulatory plan and associated activities for the year identified for the region Work with selected vendors when required within the region to deliver the required deliverables as per the defined process Assist the head of scientific communications in designing an overall plan of action based on end-customers feedback & improving course content and delivery. Stakeholders : Work closely with medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables Liaise with the Medical department to ensure relevant & customized are delivered per expectation About you Experience : 5 years of experience supporting international pharmaceutical companies: medical affairs, clinical development, pharmacovigilance with experience in at least one of the therapeutic areas- cardiovascular, metabolism, diabetes and lipid, CNS, oncology, anti-infectives, internal medicine Soft skills : Stakeholder management; communication skills; and ability to work independently and within a team environment Technical skills : As applicable (Including but not limited to Medical operational excellence, time, and risk management skills, Excellent technical (medical) editing and writing skills) Education : Medical degree MBBS; MD Languages : Excellent knowledge of the English language (spoken and written)
Posted 1 week ago
10.0 years
11 - 16 Lacs
Sahibzada Ajit Singh Nagar
Work from Office
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Job Purpose: Provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed products Provide medical guidance and input to Drug Safety Associates (DSAs) and specialists in medical aspects of drug safety Function as pharmacovigilance representative/safety scientist General Maintaining a good working knowledge of the Adverse event profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and international drug safety regulations Maintaining an awareness of global regulatory requirements and reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting Maintaining excellent knowledge of the safety profile of assigned products Communicating and discussing issues related to review process with Project Manager Interacting with internal and external contacts for resolving issues Maintaining a good working knowledge of relevant regulatory guidelines Attend and present client/cross functional meetings along with other stakeholders Training and mentoring new team member, as required Working as Subject Matter Experts (SMEs) Assisting the Manager for inspection readiness activities and audits Provides inputs for process improvisations Works closely with Manger for process co-ordination and to ensure meeting all KPIs for the process. Case report Medical review (as applicable) Performing medical review of cases according to client Standard Operating Procedures (SOPs) and liaising with the client, as required Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality Assessing seriousness and expectedness of reported events Providing medical advice to DSPs and case processing team Skills: Excellent interpersonal, verbal and written communication skills Computer proficiency, an ability to work with web-based applications and familiarity with the Windows operating system Client focused approach to work A flexible attitude with respect to work assignments and new learnings Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Ability to assess the clinical relevance of medical data and to interpret its clinical meaning is essential Willingness to work in a matrix environment and to value the importance of teamwork Strong knowledge of international drug regulation including GCP, GVP Knowledge and Experience: Relevant experience of minimum 2 Years in Pharmacovigilance/ drug safety is desirable. Education: MBBS/Post Graduation in Medicine.
Posted 1 week ago
1.0 - 3.0 years
5 - 9 Lacs
Bengaluru
Work from Office
Clario s medical imaging expertise is unparalleled in the industry. With over 30 years of experience, we provide seamless, secure, and compliant medical imaging solutions that optimize clinical trials. Our commitment to excellence has made us a leader in the medical imaging core lab sector. We are seeking dedicated and skilled Medical Imaging Technologists to join our growing operations team in India. What we offer Competitive compensation (fixed + variable) Attractive benefits (security, flexibility, support and well-being) Engaging employee programs Technology for hybrid working and great onsite facilities What youll be doing Our Medical Imaging Technologists ensure Quality, including Protocol Compliance and Technical Adequacy, of Image Data by: Reviewing and analysing image data for clarity and quality Verifying image data is in compliance with project protocol requirements Generating image queries when needed Working with therapeutic team to notify Sponsor/Site for proper resolution of quality issues Assisting in archiving data for completed projects Performs other image analysis functions as may be required by: Performing client or internal demonstrations of image processing Reviewing and preparing images for submission to client and/or agency Identifies and communicates Project Requirements as they relate to the image quality review (IQR) processes by Reviewing evaluations of potential clinical research sites and verifying the accuracy of information pertaining to site personnel, medical imaging equipment, imaging protocol and data archival capabilities Providing support for technical imaging related issues Performing study initiation/technical visits to educate site personnel on image acquisition protocol, data archival, and data transmittal procedures including form(s) completion Assisting in the design and implementation of study related forms Assisting in writing and reviewing imaging guidelines/manuals Assisting in reviewing Site Surveys Maintains Quality Service and Departmental Standards by Reading, understanding and adhering to organizational Standard Operating Procedures (SOPs) Assisting in establishing and enforcing departmental standards Participating in user acceptance testing for new tools and software enhancements Participating in the modification of company SOPs related to IQR What we look for Bachelor s degree preferred 2+ years as Imaging Technologist in a imaging center or relevant clinical trial experience preferred Experience with PET is preferred Experience with X-Ray, MRI & CT modalities advantageous Experience working with computer software including Word, Excel and Access preferred Experience working with clinical trials and/or within pharmaceutical environment preferred Individuals who are able to work remotely and open to European and US time zone working hours
Posted 1 week ago
4.0 - 8.0 years
15 - 20 Lacs
Ahmedabad
Remote
The Clinical Trial Physician is responsible for providing medical input within the organization as well as to external partners and performing medical review tasks within the context of clinical trials. Furthermore, the Clinical Trial Physician is responsible for undertaking scientific/medical writing tasks within the organization. Role & responsibilities Is responsible for the development of: All study related documents that fall under the Clinical Science Department scope (e.g., Study Protocols, ICFs - in collaboration with other departments e.g., Clinical Operations, Regulatory, as required -, Pharmacy Manuals, Medical Review Plans, etc.), Scientific presentations and manuscripts, Medical training material (i.e. therapeutic area and study protocol training material) Delivers internal and external study protocol and therapeutic area training courses Provides medical expertise and consultation within the Company on key therapeutic areas of the clinical development program Provides guidance to all involved departments on the medical and scientific aspects of the assigned clinical trials/projects. Responds to medical queries from all involved parties in assigned clinical trials (e.g., CRAs, Project Managers, Clinical Operations Managers, Investigators) and collaborates with all concerned staff in maintaining an up-to-date study-specific Q&A log Is available 24/7 to respond to urgent medical/protocol related issues derived from an Investigational Site, as applicable Performs periodic medical review of the data from clinical trials according to the study-specific Medical Review Plan requirements (e.g., review of eligibility, review of efficacy and safety data). Performs real-time medical review on urgent medical and safety issues, as needed Collaborates with and provides medical input to the Data Management staff to ensure the successful development of the study-specific eCRF Attends Investigator Meetings and Conferences, as applicable Complies with the Company's Quality and Information Security Management Systems and applicable national and international legislation, including legislation for data protection and ICH GCP requirements Preferred candidate profile Required Medical Degree (MBBS, MD) Preferred: Clinical experience in the therapeutic area of the assigned study or of the Companys clinical development program - Preferred: 2 years of experience in a CRO or in the pharma industry in a relevant role (Clinical, Medical Information, Medical Affairs or PV) Key competencies Exceptional written and oral use of English In-depth knowledge of medical and drug terminology Good medical judgement and ability to make medical decisions Excellent communication skills Excellent business acumen Initiative taking and team working attitude Excellent Organizational skills Innovative thinking Excellent IT skills Deep understanding of the Clinical Development industry
Posted 1 week ago
3.0 - 7.0 years
10 - 15 Lacs
Ahmedabad
Remote
To use advanced data analysis for providing actionable insights that support data-driven decision-making within teams by utilizing R programming language, developing automation tools for oversight and standardized reporting templates to enhance the efficiency and consistency of information across the organization. Role & responsibilities Data Analytics and Reporting Design and develop detailed reports leveraging various databases, using R language to generate meaningful insights. Proactively develop automation tools, standardized reporting tools & templates (including slides) for use by stakeholders to enable consistent presentation of information across the teams. Create visualizations and trend analysis to identify patterns in study performance or other relevant areas. Monitor and document any bugs or issues related to the reporting tools and work with the concerned teams for timely resolution. Stakeholder Collaboration Collaborate with cross-functional teams proactively to gather and understand reporting requirements, translating them into programming Specifications. Assist leadership teams in data-driven decision making by providing actionable insights such as budget projections, resource allocation, Full Time Equivalent (FTE) predictions etc. through various reports. Act as the bridge between data teams and other departments, gathering requirements and output Specifications for new analytical tools or reports. Utilize data to perform analytics, thereby predicting future requirements, provide real-time analysis of study quality metrics, site performance metrics and generate reports for Source Data Verification (SDV). Analytics Project Management Maintain clear documentation of methodologies, data processes, and report-generation protocols to ensure transparency and reproducibility of analyses. Assist in the development of performance metrics based on communicated requirements, contributing to the overall efficiency and effectiveness of clinical operations. Develop clear and concise communication around project progress, key findings, and recommendations to various stakeholders. Keep track of the number of projects progress and provide regular reports to Associate Director, Biostatistics and Analytics. Policies, Processes & Procedures Conduct day to day activities & follow all relevant policies, processes, standard operating procedures and instructions so that work is carried out in a controlled and consistent manner. Assist in the updating departmental and role Specific programming standards, Standard Operating Procedures (SOPs), Working Procedural Documents (WPDs), and templates to reflect current practices and regulatory requirements. Implement new initiatives/ projects as per established policies to meet future requirements of the function. Comply with the company's Quality and Information Security Management Systems and applicable national and international legislation, including legislation for data protection Key interactions Clinical operations Biostatisticians Clinical Informatics Clinical Data Management Project Management Functional / Behavioral Skills required to execute the role R Programming Automation and Tool Development Data Analysis and Interpretation Documentation and Reporting Project Management Communication Detail orientation Problem solving Time management Hands on experience in data analysis, preferably within a clinical research or healthcare setting
Posted 1 week ago
3.0 - 5.0 years
20 - 25 Lacs
Hyderabad
Work from Office
Challenging. Meaningful. Life-changing. Those aren t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers. bms. com/working-with-us . Job Description: The Business Analyst II will play a critical role in portfolio analytics team in Hyderabad. They will be responsible for developing and maintaining assessment of our portfolio vs. competitors, articulating portfolio health to the senior leadership and undertaking in-depth assessment of clinical trials targeted by competitors. The right candidate should have extensive experience in conducting therapeutic area assessments, consolidating long term forecasts for the company s portfolio, hands-on expertise to build excel-based capabilities from scratch and exposure to SQL/ VBA/Python/ and other coding/ reporting platforms. Key Responsibilities: Portfolio Health Analysis: Conduct competitor concentration analysis by therapeutic indication using external datasets. Benchmark success rates versus modeled PTRS and conduct internal portfolio assessment vs. external perspective Asset Favorability Framework: Develop leadership dashboard capturing portfolio ranking across key variables of interest and summarize the findings for senior leadership Clinical Trial Analysis: Map our existing trials to therapeutic areas of interest, articulate risk/reward and summarize findings in the form of actionable insights Long-Term Financial Planning (LTFP): Conduct early asset modeling for LTFP, including discrete models early-stage assets and conduct scenario analytics to derive range of possibilities given market dynamics Collaborate with cross-functional teams to gather and analyze relevant data, market trends and historical performance Proactively and continuously assesses the relevant marketplace and its dynamics, customers, competitors and future development trends Provide training, guidance and mentorship to junior analysts and team members as required Skills and Competencies: Strong analytical skills and experience in conducting portfolio analytics for pharmaceutical MNC Deep understanding of therapeutic areas, financial planning process and ability to conduct easy-stage asset evaluations Strong communication skills with the ability to present complex information to non-technical stakeholders in a clear manner Strong project management skills and the ability to work independently or as part of a team. Strong attention to detail and ability to work with large datasets to ensure accuracy and reliability of forecasts Experience: We welcome people with a bachelors or masters degree in a relevant field such as Statistics, Mathematics, Economics, Operations Research or a related discipline. Proven experience (typically 3 to 5 years) in a portfolio analytics and long-range forecasting, preferably within the biopharma or pharmaceutical industry. Hands-on expertise in pharmaceutical forecasting and commercial analytics, modeling platforms, Advanced Excel & VBA, data manipulation software and visualization tools (e. g. Tableau, Python, SQL, Power BI, etc. ) Awareness of Pharma datasets (Visible Alpha, ProSight, Evaluate Pharma, DRG, Biodmedtracker, IQVIA, Pharma projects, Alpha sense) will be a plus If you come across a role that intrigues you but doesn t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. With a single vision as inspiring as Transforming patients lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms. com . Visit careers. bms. com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers. bms. com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Posted 1 week ago
4.0 - 8.0 years
20 - 27 Lacs
Hyderabad
Work from Office
Challenging. Meaningful. Life-changing. Those aren t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers. bms. com/working-with-us . Job Description: This is an individual contributor role responsible for driving portfolio analytics, portfolio health checks and long-term portfolio revenue projections for our internal pipeline assets. The right candidate should have extensive experience in presenting portfolio assessments to senior leadership, identifying potential gaps and associated interventions needed, and hands-on expertise to build excel-based capabilities from scratch and exposure to SQL/ VBA/Python/ and other coding/ reporting platforms. Key Responsibilities: Portfolio Health Analysis: Conduct competitor concentration analysis by therapeutic indication using external datasets. Benchmark success rates versus modeled PTRS and conduct internal portfolio assessment vs. external perspective. Identify gaps, articulate findings for senior leadership for actionability and help junior members to understand broader context Asset Favorability Framework: Thought partner in developing and maintaining leadership dashboard capturing portfolio ranking across key variables of interest Long-Term Financial Planning (LTFP): Conduct early asset modeling for LTFP, including discrete models early-stage assets and conduct scenario analytics to derive range of possibilities given market dynamics Project and People Management: Operate as a project manager along with individual contributor role, managing competing priorities, work allocation, ensuring on-time delivery of projects, provide oversights and feedback to analysts, and participate in talent planning and year end reviews for the associates aligned to the team Collaborate with cross-functional teams to gather and analyze relevant data, market trends and historical performance Provide training, guidance and mentorship to junior analysts and team members as required Provide significant input into and communicate diplomatically regarding performance reviews, promotions and compensation actions for team members Strive to create standards for dataset usage through central repositories, cross team collaboration Skills and competencies: Strong analytical skills and experience in conducting portfolio analytics for pharmaceutical MNC SME in therapeutic area assessments, financial planning process and commercial forecasting for easy-stage assets Strong verbal/written skills, with the ability to effectively communicate with senior leadership Strong project management and interpersonal skills, with the ability to lead diverse teams and manage a heavy workload Strong creative problem-solving skills and business acumen, with the ability to identify key findings from disparate data sources to provide recommendations Ability to work in matrix organization Experience: We welcome a bachelor s or master s (MBA preferred; quantitative area) 10+ years pharmaceutical commercial analytics or forecasting experience Experience operating successfully in a complex organizational environment Experience interacting with senior management, understanding, anticipating, and fulfilling their insight/ analytical information requirements Hands-on expertise in pharmaceutical forecasting, portfolio and commercial analytics, deep understanding of therapeutic areas, expertise in modeling platforms, Advanced Excel & VBA , data manipulation software and visualization tools (e. g. Tableau, , Python, SQL, PowerBI, etc. ) Expertise on few of the datasets (Visible Alpha, ProSight, Evaluate Pharma, DRG, Biodmedtracker, IQVIA, Pharmaprojects, Alpha sense) will be a plus If you come across a role that intrigues you but doesn t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. With a single vision as inspiring as Transforming patients lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms. com . Visit careers. bms. com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers. bms. com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Posted 1 week ago
3.0 - 5.0 years
12 - 14 Lacs
Hyderabad
Work from Office
Challenging. Meaningful. Life-changing. Those aren t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers. bms. com/working-with-us . Position: Full Stack Developer II Location : Hyderabad, India Position Summary At BMS, digital innovation and Information Technology are central to our vision of transforming patients lives through science. To accelerate our ability to serve patients around the world, we must unleash the power of technology. We are committed to being at the forefront of transforming the way medicine is made and delivered by harnessing the power of computer and data science, artificial intelligence, and other technologies to promote scientific discovery, faster decision making, and enhanced patient care. If you want an exciting and rewarding career that is meaningful, consider joining our diverse team! As a Full Stack Developer II based out of our BMS Hyderabad you are part of the GDD Business Insights & Technology team that delivers data and analytics capabilities for RWD, Portfolio & Trial Operations functions. The ideal candidate will have a strong background in building, designing and improving the user experience of data products, platforms and services. The role involves a combination of creative and analytical skills, as well as an understanding of user behavior, and technology. Key Responsibilities The Full Stack Developer II will be responsible for creating user and web applications using Python, SQL and React JS Write clean, efficient, and maintainable code while following best practices. Develop project and portfolio user interfaces like report visualizations and dashboards as a key capability and value driver User research: Conducting user research to understand user needs, behaviors, and pain points. This may involve surveys, interviews, and usability testing. Accountability and involvement in wireframing, prototyping, and creating high-fidelity designs to enhance user experience. Collaboration with stakeholders: Collaborating with product managers, Senior Data Visualization Engineer, Data Engineers, and other stakeholders to ensure that the user experience aligns with business objectives and technical requirements. Accessibility: Ensuring that digital products and services are accessible to users with disabilities and comply with accessibility guidelines. Help analyze data multiple sources of spectrum-related information, recommend and develop reports Staying up-to-date with industry trends: Keeping up-to-date with the latest trends and advancements in Engineering, UX design and technology, and applying this knowledge to enhance the organizations data pipeline and UX design capabilities. Serves as the Subject Matter Expert on Data pipelines and BI reporting Comfortable working in a fast-paced environment with minimal oversight Prior experience working in an Agile/Product based environment. Provides strategic feedback to vendors on service delivery and balances workload with vendor teams. Qualifications & Experience Degree in Computer Science, Design & Engineering, Biotechnology, or a related field 3-5 years proven working experience of front-end and back-end technologies, including - Python, flask, SQL alchemy, sql, React. js, HTML, CSS, JavaScript, and RESTful APIs. Hands on experience on AWS Glue, Azure and Tableau is desired Experience with rapid wireframing, prototyping and storyboarding tools like Miro boards, and Adobe Creative Cloud Data Visualization Engineer tool set Knowledgeable in designing for both responsive and fixed size applications. Ability to wireframe, prototype, apply Design thinking principles and validate data products. At least 3 years technical expertise in product design and development, data visualization techniques Familiarity with database and ETL processes from Information management and consumption standpoint is needed is a plus Strong analytical and problem-solving skills Excellent communication and collaboration skills Functional knowledge or prior experience in Lifesciences Research and Development domain is a plus. Experience and expertise in establishing agile and product-oriented teams that work effectively with teams in US and other global BMS site. Initiates challenging opportunities that build strong capabilities for self and team. Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential of each of our colleagues. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. If you come across a role that intrigues you but doesn t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. With a single vision as inspiring as Transforming patients lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms. com . Visit careers. bms. com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers. bms. com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Posted 1 week ago
1.0 - 3.0 years
12 - 14 Lacs
Hyderabad
Work from Office
Challenging. Meaningful. Life-changing. Those aren t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers. bms. com/working-with-us . Job Description The Decision Analyst will play an instrumental role for BMS, as they will be responsible for applying advanced statistical analysis and optimization techniques to support data-driven decision-making processes. The Decision Analyst will develop and implement descriptive/explanatory models, decision support models, segmentation strategies, portfolio analyses, test/experimental designs, and measurement frameworks to provide actionable insights and recommendations that enhance business performance and drive growth in the region. Roles & Responsibilities: Partner with senior analysts to implement statistical models, decision support models, and optimization techniques to solve complex business problems. Collaborate with cross-functional teams to gather/analyze data, define problem statements and identify KPIs for decision-making Apply statistical analysis, regression modelling, clustering, segmentation, etc. to uncover trends and drivers in the data Conduct portfolio analyses to optimize resource allocation, product positioning and investment strategies Partner with senior analysts to design & implement test designs to evaluate effectiveness of marketing campaigns, pricing strategies, or other business initiatives. Partner with senior analysts to develop measurement frameworks and KPI dashboards to monitor business performance and provide actionable insights to stakeholders Collaborate with stakeholders to understand business objectives and translate them into projects and actionable recommendations With senior analysts prepare reports and visualizations to communicate insights and recommendations to stakeholders at various levels of the organization Stay up-to-date with industry trends, emerging methodologies, and best practices related to statistical analysis, optimization and decision support Skills and Competencies: Strong analytical thinking and problem-solving skills with a working knowledge of statistical analysis, optimization techniques and decision support models Strong understanding of experimental design, hypothesis testing and A/B testing methodologies Solid ability to present complex information to non-technical stakeholders in a concise manner Ability to work collaboratively in cross-functional teams and manage multiple projects simultaneously Strong attention to detail and ability to work with large datasets to ensure accuracy and reliability of analysis Strong project management skills and the ability to work independently or as part of a team Strong business acumen and the ability to translate analytical findings into actionable insights and recommendations Experience: We welcome a bachelors or masters degree in a relevant field such as Statistics, Mathematics, Economics, Operations Research or a related discipline. Proven experience (typically 1 to 3 years) in a decision analysis, statistical modeling, or optimization role, preferably within the biopharma or pharmaceutical industry. Experience working with large datasets, statistical software packages (e. g. , R, SAS, Python) and data visualization tools Experience with descriptive/explanatory models, regression modeling, clustering, segmentation and portfolio analysis Familiarity with the biopharma industry, including market dynamics, regulatory requirements and healthcare data sources Certification or training in decision analysis, statistical modeling or related If you come across a role that intrigues you but doesn t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. With a single vision as inspiring as Transforming patients lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms. com . Visit careers. bms. com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers. bms. com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Posted 1 week ago
2.0 - 6.0 years
7 - 8 Lacs
Bengaluru
Work from Office
Job Description Technical Support Engineer - Python About ArisGlobal ( www.arisglobal.com ): ArisGlobal is empowering life science organizations to deliver breakthroughs faster , accurately , and with precision. This is paramount for the passage of lifesaving medications and products VIA clinical trials, using our software and technology. As an industry leader, ArisGlobal provides our SaaS leading technology and services to 40/50 top Bio-pharmaceutical corporations, 4/5 of the most advanced global pharmaceutical companies and nine government-health authorities, including the FDA, Health Canada and the NMPA, for example, around the world. 2021 has presented simultaneous developments in the global Drug Safety and Pharmacovigilance Software Market, projecting unfaltering growth through 2027. Effectively harnessed by prominent market drivers, ArisGlobal is named a Key Player. Located in Miami, New Jersey, Budapest, Dublin, Darmstadt, Rome, Tokyo, Shanghai, Bangalore, Mysore, our global presence is clear, and we are growing faster than ever . Requirements: Bachelor s degree in computer science, Information Technology. 2-6 years of experience in Technical Support/Application Support and IT service management, preferably in a global organization. Minimum 1+ Years of strong experience in Python (Mandatory) Good SQL (OR) PL/SQL skills To fetch case data based on customer requirements. To write update statements on scenario basis for case correction. Should be ready work in 24X7 shift based support team Strong knowledge of IT service management frameworks (ITIL) and best practices. Proven track record in driving support excellence and customer satisfaction. Experience in managing customer service level agreements. Excellent analytical, problem-solving, and decision-making skills. Strong leadership and interpersonal skills, with the ability to collaborate effectively across teams and influence stakeholders. Collaborative mindset and the ability to work seamlessly within diverse teams and drive concept implementation. Exceptional communication and presentation skills, both written and verbal. Working knowledge with ticketing tools like Jira, ZenDesk, ServiceNow. Roles & Responsibilities: As Tier-2 engineer for you would be responsible for providing application functionality support and technical support for ArisGlobal Life Sphere applications, associated interfaces or any other product of ArisGlobal. Take ownership of tickets logged by customer and delivery excellent customer experience that meets ArisGlobal organizational values Collaborate with cross-functional teams and support Service Delivery managers to establish service delivery standards and best practices, ensuring alignment with business objectives. Monitor and analyse service performance using industry-leading methodologies, identify areas for improvement, and implement corrective actions. Lead/Collaborate in service improvement initiatives, leveraging continuous improvement methodologies and frameworks. Oversee incident and problem management processes, ensuring timely resolution and minimizing impact on operations. Foster a culture of customer-centricity within the organization, promoting a high level of customer service and engagement. Good To have skills: Good understanding of Pharmacovigilance Added advantage if you possess the below listed experience or similar enterprise products experience. Working knowledge with case processing life cycle from case creation to distribution.
Posted 1 week ago
2.0 - 4.0 years
5 Lacs
Bengaluru
Work from Office
Job Description Technical Support Engineer About ArisGlobal ( www.arisglobal.com ): ArisGlobal is empowering life science organizations to deliver breakthroughs faster , accurately , and with precision. This is paramount for the passage of lifesaving medications and products VIA clinical trials, using our software and technology. As an industry leader, ArisGlobal provides our SaaS leading technology and services to 40/50 top Bio-pharmaceutical corporations, 4/5 of the most advanced global pharmaceutical companies and nine government-health authorities, including the FDA, Health Canada and the NMPA, for example, around the world. 2021 has presented simultaneous developments in the global Drug Safety and Pharmacovigilance Software Market, projecting unfaltering growth through 2027. Effectively harnessed by prominent market drivers, ArisGlobal is named a Key Player. Located in Miami, New Jersey, Budapest, Dublin, Darmstadt, Rome, Tokyo, Shanghai, Bangalore, Mysore, our global presence is clear, and we are growing faster than ever . Requirements: Bachelor s degree in computer science, Information Technology. 2-4 years of experience in Technical Support/Application Support and IT service management, preferably in a global organization. Good SQL (OR) PL/SQL skills To fetch case data based on customer requirements. To write update statements on scenario basis for case correction. Should be ready work in 24X7 shift based support team Strong knowledge of IT service management frameworks (ITIL) and best practices. Proven track record in driving support excellence and customer satisfaction. Experience in managing customer service level agreements. Excellent analytical, problem-solving, and decision-making skills. Strong leadership and interpersonal skills, with the ability to collaborate effectively across teams and influence stakeholders. Collaborative mindset and the ability to work seamlessly within diverse teams and drive concept implementation. Exceptional communication and presentation skills, both written and verbal. Working knowledge with ticketing tools like Jira, ZenDesk, ServiceNow. Roles & Responsibilities: As Tier-2 engineer for you would be responsible for providing application functionality support and technical support for ArisGlobal Life Sphere applications, associated interfaces or any other product of ArisGlobal. Take ownership of tickets logged by customer and delivery excellent customer experience that meets ArisGlobal organizational values Collaborate with cross-functional teams and support Service Delivery managers to establish service delivery standards and best practices, ensuring alignment with business objectives. Monitor and analyse service performance using industry-leading methodologies, identify areas for improvement, and implement corrective actions. Lead/Collaborate in service improvement initiatives, leveraging continuous improvement methodologies and frameworks. Oversee incident and problem management processes, ensuring timely resolution and minimizing impact on operations. Foster a culture of customer-centricity within the organization, promoting a high level of customer service and engagement. Good To have skills: Good understanding of Pharmacovigilance Added advantage if you possess the below listed experience or similar enterprise products experience. Working knowledge with case processing life cycle from case creation to distribution.
Posted 1 week ago
6.0 - 7.0 years
8 - 9 Lacs
Hyderabad
Work from Office
Summary -Provide expert support and functional and technical knowledge to ensure the scientific integrity/validity for clinical development, early development, and/or research projects. Participate in the full lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. Provide statistical support for regulatory submissions including planning, analysis and reporting of clinical safety and efficacy summaries. May also provide statistical support to research or other R&D areas. -Responsible for advising/leading the planning, development & implementation of Industry (CDISC and regulatory) compliant, high quality, clinical data standards, infrastructure or automation technologies. Providing expert support and stellar customer focus to business users and teams on their use, including: -Data standard collection tools in EDC (CRFs, edits checks, derivations, core configurations) -Data transfer specifications -Analysis data/TFL standards/Define -Automation solutions / technologies -Business infrastructure, business rules and guidelines. About the Role Major accountabilities: Drive the implementation of data analytics reports and dashboards for optimal data review by working with the users to establish robust user specifications and with programmers to implement the optimal output -Translate business requirements into logical models and provide direction to the development team to translate business logic. Lead authoring of the user requirements document, functional specifications and functional testing scripts -Proactively identify or address needs for optimal data review working with users and programmers as appropriate. Implement and execute robust project plans for delivery, ensuring customer needs are addressed in a timely manner. Provide coordination between the project resources so that deadlines are met on deliverables. Drive development of appropriate user training. Drive all necessary change management activities related to implementation of new data review tools / reports as related to data cleaning, review and visualization. Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Key performance indicators: Timely execution of of projects & data requests -Feedback from project sponsors and key stakeholders -Adherence to Novartis policy and guidelines -Metrics and Adherence to KPIs Minimum Requirements: Work Experience: Functional Breadth. Cross Cultural Experience. Managing Crises. Collaborating across boundaries. Operations Management and Execution. Skills: Automation. Biostatistics. Clinical Trials. Computer Programming. Metadata Management. Statistical Analysis. Languages : English. Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:
Posted 1 week ago
2.0 - 3.0 years
3 - 4 Lacs
Bengaluru
Work from Office
Key Responsibilities Design statistical analysis plans for clinical trialsobservational studiesand laboratory experiments. Perform statistical analyses using appropriate software (e.g.SASRPython). Collaborate with clinical researchersdata managersand regulatory teams to ensure data integrity and compliance. Interpret and communicate statistical results clearly to cross-functional teams and stakeholders. Prepare tableslistingsand figures for clinical study reports and publications. Support the preparation of documents for regulatory submissions (e.g.FDAEMA). Stay current with advancements in biostatistics and relevant regulatory guidelines. Contribute to protocol developmentdata monitoringand interim analysis. Provide statistical consulting to internal teams on study design and methodology.
Posted 1 week ago
4.0 - 7.0 years
7 - 11 Lacs
Bengaluru
Work from Office
At Quanticate, were pioneers in providing top-tier statistical and data management support to our clients. Were seeking a dedicated "Clinical Data Manager I" whos committed to upholding the highest standards, following procedures, and ensuring compliance with regulations, all while providing exceptional customer care. As a "Clinical Data Manager I" you will lead, co-ordinate, and action all tasks relating to Clinical Data Management from the start to the finish of a study to project manage studies across CDM functions. Core Accountabilities: Activities required of a Clinical Data Manager I (however not restricted to) are as below: To contribute to the efficient running of the CDM department as part of the CDM leadership team. Ensure launch, delivery, and completion of all CDM procedures according to contractual agreement and relevant SOPs, guidelines, and regulations To pro-actively keep abreast of current clinical data management developments and systems To assist in the creation and review of in-house SOPs. To research and provide input into in-house strategies and systems. To perform medical coding activities on projects, if assigned. To perform other reasonable tasks as requested by management. Ensure consistency of process and quality across projects. Project management for allocated projects: To help plan and manage study timelines and resources. To manage progress against schedules and report to management. To perform project management across all functions for a study as appropriate. Management of CRFs and all related tasks Management of allocated staff: Allocation of projects in conjunction with Project Management, as appropriate Performance reviews, as required. Administer training and development of staff, as required. Key Relationships: Act as the primary CDM contact, both external and internal, for Quanticate projects. Manage work assignment and delivery of project tasks to the data processing and programming team as required Line management responsibilities for any assigned direct reports, including professional development/training and performance appraisals. Qualified to an appropriate standard, preferably to degree level in a life sciences subject Four to seven years of relevant experience in CRO Clinical Data Management domain. Extensive knowledge of
Posted 1 week ago
3.0 - 6.0 years
19 - 21 Lacs
Bengaluru
Work from Office
Overview We have an exciting role of Manager - Medical Copywriter to drive and translate creative and contemporary ideas to solid design and impact. You will have a key role in design and deployment of creative campaigns with our global clients, including many Fortune 50 companies. About US We are an integral part of Annalect Global and Omnicom Group, one of the largest media and advertising agency holding companies in the world. Omnicom’s branded networks and numerous specialty firms provide advertising, strategic media planning and buying, digital and interactive marketing, direct and promotional marketing, public relations, and other specialty communications services. Our agency brands are consistently recognized as being among the world’s creative best. Annalect India plays a key role for our group companies by providing stellar products and services in areas of Creative Services, Technology, Marketing Science (data & analytics), Market Research, Business Support Services, Media Services, Consulting & Advisory Services. We are growing rapidly and looking for talented professionals like you to be part of this journey. Let us build this, together! Responsibilities This is an exciting role and would entail you to Manage cross-functional partners to deliver medical content for a variety of audiences (digital and print) while also handling medical copywriting and veeva submissions work Copywriting & Content Development Write clear, engaging, and medically accurate content for a range of audiences - including press materials, consumer campaigns, digital assets, and educational tools. •Translate complex clinical and scientific information into language that resonates with non- specialist audiences, including patients, caregivers, and media outlets. Develop a refined understanding of the brand, disease, and the overall therapeutic/treatment category Ensure the creation of all content is developed with appropriate tone, style, and structure based on brand strategy, creative brief, and client expectations Develop messaging that aligns with brand strategy, while simplifying technical data for broader understanding without compromising accuracy. Partner with internal teams (account, strategy, and creative) to ideate and execute content that is impactful, on-brand, and compliant. Revise and refine copy based on internal and client feedback and MLR reviewer input. Veeva Submission & MLR Review Support Prepare and submit materials in Veeva Vault PromoMats for MLR review, ensuring all metadata, references, and annotations are accurate and complete. Link supporting references to corresponding claims and manage annotation accuracy. •Track submission timelines and status; coordinate follow-ups, revisions, and final approvals. •Act as a bridge between creative/content teams and regulatory operations to ensure seamless submissions and compliance with SOPs. Maintain organized version control and documentation of submitted and approved materials Demonstrate an understanding of healthcare/pharma advertising communication requirements Be familiar with modular content and omnichannel marketing – develop and maintain content matrix and core claims documentation Qualifications You will be working closely with Our global creative agency teams. You will also be closely collaborating with our team of talented and designers to deliver high-quality services. This may be the right role for you if you have 11+ years of experience in healthcare communications agencies (AMA experience is preferred) Bachelor's degree or equivalent experience with a focus on pharma/science/medicine Portfolio containing work samples that demonstrate strong conceptual abilities, creative thinking, and exceptional writing skills in a variety of communication forms (e.g., sales aids, direct mail, websites, social media) for a variety of audiences (e.g., healthcare professionals, patients, consumers) Understanding of omnichannel marketing, modular content, and processes for content development Experience with referencing and annotating, and MLR submissions requirements and processes Excellent leadership, management and client-facing communication skills Strong organizational skills, attention to detail, and ability to multitask. An ability to understand and process healthcare information Ability to multi-task in a faced-paced environment as a member of a highly collaborative team The desire to work with a diverse group of teams, projects, and clients.
Posted 1 week ago
5.0 - 10.0 years
5 - 14 Lacs
Bengaluru
Hybrid
We are hiring a Business Analyst for the Bangalore location in a Hybrid mode. Role Overview The Business Analyst role is focused on the clinical domain, requiring strong knowledge of clinical trials, clinical research associates, investigators, and subjects (patients). The candidate should be familiar with Electronic Data Capture (EDC) systems and Clinical Research Forms (CRFs). Key Requirements and Skills: SQL Knowledge : The candidate should have a basic understanding of SQL queries. Clinical Domain Expertise : Strong knowledge in clinical trials and related processes. Business Analyst Skills : Understanding of business goals, Agile methodology, and waterfall methodology. Technical Skills : Experience with JIRA, TopTeam, SynapseRT, and proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Project, and Visio). Writing Skills : Strong technical and business writing skills, including knowledge of technical and grammatical editing. Communication Skills : Ability to communicate technical concepts to non-technical audiences and business concepts to technical audiences. Modelling Languages : Ability to learn and use modelling languages when required. Negotiation and Customer Management : Skills in negotiation and customer management. If interested, drop your profile at nusrath.begum@priglobal.com along with the following details: Total Experience: Current CTC: Expected CTC: Notice Period:
Posted 1 week ago
1.0 - 6.0 years
10 - 20 Lacs
Pune, Chennai, Mumbai (All Areas)
Work from Office
*Greetings From You & I Consulting ! You & I Consulting has always been in the spotlight for getting placed in 64+ MNC's PAN India. *Hurry Do Not Miss This Opportunity To Work For Global Giant MNC. We are hiring for the below locations under Medical Reviewer Role!! *Open Locations :- * Pune/ / Chennai / Mumbai *Mode Of Interview - Virtual *Mode Of Work :- Work From Office * CTC Upto - 10 To 24Lpa *Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app) or email your CV to puja@careersuni.com PFB Job Insights for Medical Reviewer Role!! Author a CCC for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database. Detail any requests for changes to the case, including the narrative. Skills required:- Computer Literate (good knowledge of MS Office) Sound understanding of the Drug Safety and Regulatory process Good problem solving and decision-making skills Capability to lead by motivation and example Ability to prioritize schedule and organize Excellent interpersonal and communication skills * * *Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app) email your CV to puja@careersuni.com ***Note we also have open positions for the below skills :- * * *Call Now our HR Specialist for more details:- @ puja - 8250242229 (call or whts app) email your CV to puja@careersuni.com *Aggregate Reporting / Clinical Data Management / Clinical SAS / SQL Programmer / EDC Programmer / Medical Monitor / HEOR Health Economist Role / SAS + R / Statistical Programmer / Study Data Manager *Though We Try and Answer The Calls Immediately, but Due to Heavy Call Flow The Below Numbers Might Be Busy At Times. In case you find the number busy, please whatsapp your details to us in the below format: - Name- Mobile number - Mail - Qualification - Total work experience - Current Organization- Location - Last CTC Expected CTC:- *Interested candidates can even refer their friends or relatives provided the criteria *FOR interview Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app) email your CV to puja@careersuni.com
Posted 1 week ago
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India has become a hub for clinical trials in recent years, with a growing demand for professionals in this field. Clinical trials play a crucial role in the development of new drugs and treatments, making it an exciting and rewarding career path for job seekers in the healthcare and pharmaceutical industry.
If you are looking to pursue a career in clinical trials in India, here are 5 major cities where you can find ample job opportunities:
The salary range for clinical trials professionals in India varies based on experience and expertise. On average, entry-level positions can expect a salary range of INR 3-5 lakhs per annum, while experienced professionals can earn anywhere from INR 8-15 lakhs per annum.
In the field of clinical trials, a typical career progression may include roles such as Clinical Research Associate, Clinical Trial Manager, Clinical Operations Manager, and eventually moving up to positions like Clinical Project Manager or Director of Clinical Operations.
In addition to expertise in clinical trials, professionals in this field are often expected to have the following skills:
Here are 25 interview questions that you may encounter when applying for clinical trials roles in India:
As you prepare for a career in clinical trials in India, remember to showcase your expertise, experience, and passion for the field during interviews. With the right skills and knowledge, you can confidently pursue opportunities in this dynamic and impactful industry. Good luck!
Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.
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