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6.0 - 10.0 years

25 - 30 Lacs

Hyderabad

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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 Key Responsibilities Study Level-Responsible for all statistical tasks on the assigned trials, and perform these tasks for mid- to high- complexity trial independently with peer review/input as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plan, reporting activities. Contribute to planning and execution of exploratory analyses, and/or PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation. Initiate, drive and implement novel methods and innovative trial de-signs in alignment with the Lead Statistician. Explain statistical methodology and interpret analysis results. Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities and other drug development activities, as required. Contribute to interactions with external review boards/ethics committees, ex-ternal consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Represent the Biostatistics & Pharmacometrics Line Function on cross-functional teams for the assigned trials. Responsible for functional alignment and ensuring line function awareness throughout the assigned trials. Collaborate with other line functions. Explain statistical concepts in an easily understandable way to non-statisticians and provide adequate statistical justifications for actions/decisions/statements, when required. Establish and maintain sound working relationships and effective communication within the Clinical Trial Team and Biostatistics & Pharmacometrics team. Oversee all Biostatistics resources and deliverables for assigned trials. En-sure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities. Project level- May be a core member of an early project team for a low-complexity program and represents Biostatistics and Pharmacometrics as part of development plan with oversight. Collaborate with clinical, regulatory and other strategic functions to drive quantitative decision making in assigned indications/program with oversight. Collaborate cross-functionally (e. g. data management, programming, medical writing) to ensure timeliness and quality of statistical deliverables. Propose and implement innovative designs and methods to optimize dose finding and drug development. Contribute to planning, prioritization and tracking of program level biostatistics activities and effective partnership with vendors. Significantly contributes to project team preparation for HA Advisory Committees and meetings. Franchise or Global Line Function level: Significantly contribute to initiatives at global line function level Enterprise level- Actively contribute to cross-functional organizational / process /scientific consulting improvement initiatives. Contribute to the review and implementation of health authority guidance. Identify, evaluate, and promote the use and the acceptance within and out-side the organization, of innovative methods, through scientific collaborations, publications in scientific peer reviewed journals, presentations and chairing sessions at professional meetings. External level- Contribute to interactions with external review boards/ethics committees, ex-ternal consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Role Requirements : MS (in Statistics or equivalent) with 7+ years relevant work experience or PhD (in Statistics or equivalent) with 3+ years relevant work experience Fluent English (oral and written) Good communication and presentation skills Influences decisions that directly impact the trial/project and team ability to deliver objectives. Experience in all tasks of a statistician at the trial/experiment level and demonstrated independence in the role. Proven knowledge and expertise in statistics and its application to clinical trials; able to explain statistical designs and concepts. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modelling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Proficiency in use of statistical software packages (e. g. SAS, R). Good knowledge of drug development and Health Authority guidelines. Demonstrated effectiveness working on a multidisciplinary team to achieve team objectives. Good understanding of Franchise/Therapeutic Area and or regulatory activities. Good project management and matrix leadership skills. Ability to collaborate well with non-statistical functions. Good business ethics Why Novartis: Commitment to Diversity and Inclusion: Accessibility and accommodation Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork. novartis. com/network Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together? https://www. novartis. com / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork. novartis. com/network Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

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5.0 - 7.0 years

7 - 12 Lacs

Hyderabad

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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 . Key Responsibilities and Major Duties: R2R activities Performs R2R period-end close (e. g. , account reconciliation QC, accounts receivable, accruals, operational reporting) and reconciliation activities Monitors and manages specific month-end, quarter-end, and year-end related activities per close timetable in collaboration with local markets and third-party service provider Prepares scheduled balance sheet control reconciliations Monitors and manages internal customer satisfaction levels, taking immediate action as appropriate Complete period audits, management level reporting, and disaster recovery related activities Executes ad-hoc projects initiated by R2R leadership Relationship management and teaming Holds self and others to timelines, quality, and accuracy Risk management Articulates material risks and opportunities and takes an active role in designing and executing response or contingency plans Educational Qualification: Bachelor s degree in accounting along with CA / CPA or equivalent qualification required. Experience: A minimum of 5-7 years of experience Accounting experience within the pharmaceutical industry preferred Familiarity with SAP and SAP related applications, CRM software, among other accounting-related programs 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.

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5.0 - 9.0 years

11 - 15 Lacs

Hyderabad

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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 . Create SAS programs to generate derived analysis data sets and content for tables, listings, and figures; Perform programming validation to ensure quality of analysis d atasets and programming outputs Provides programming support for project teams, including development of programming strategies, standards, specifications and programmed analysis Support the electronic submission preparation and revi e w Reviews key planning documents (e. g. , statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programmi ng assumptions and requirements ; Assesses impact on programming activities Interacts with vendors regarding project standards, programming conventions, programming spec ifications and file transfers Provides leadership for ensuring quality of Global Biometric and Data Sciences ( GB D S) deliverables by consistently applying s tandards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work p ractices Identifies opportunities for increased efficiency and consistency within GB D S and our interactions with strategic vendors Independently leads and / or performs programming assignments with minimal supervision Support improvement initiatives Minimum Requirements: Bachelor s degree in statistics, biostatistics, mathematics, computer science or life sciences required . At least 5 years programming experience in industry recommended . For US positions: US military experience will be considered towards industry experience . Demonstrated proficiency in using SAS , R or other programming languages to produce deriv ed analysis datasets and TFLs. Have in -depth understanding of clinical data structure ( e. g. CD I SC standards) and relational database. Demonstrated skills in using software tools and applications, e. g. , MS office, XML, Pinnacle 21. Demonstrated ability in the handling and processing of upstream data, e. g. , multiple d ata forms, workflow, eDC , SDTM. Demonstrated ability in providing outputs to meet downstream requirements, e. g. , ADaM , Data Definition Table, e-submission. Have good understanding of regulatory, industry, and technology standards and requirements. Have good knowledge of statistical terminology, clinical tests, medical terminology and protocol designs. Demonstrated ability to work in a team environm ent with clinical team members. Preferred Requirements : Minimum of 5 years clinical / statistical programming experience within pharmaceutical clinical development - Supporting regulatory filings ( e. g. NDA, BLA, MAA) Knowledge of the drug development process, clinical trial methodology , statistics and familiarity with global regulatory requirements Experience in other software packages ( e. g. R) Experience with the Linux operating system 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.

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5.0 - 10.0 years

15 - 17 Lacs

Mumbai

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YOUR TASKS AND RESPONSIBILITIES: This role will be responsible for oversight on end-to-end clinical trial activities from quality perspective. This role will be accountable for Quality Compliance (QC) activities of Clinical Trial Medical Science team and Operations team, Clinical Trial Supply Management (CTSM) team, and Clinical Data Management team by way of Review of all study related activities, processes, procedures and adherence to applicable regulations and guidelines to ensure 24x7 Inspection/audit readiness. This role will be responsible for establishing the procedures and trainings of teams which ensure protection of human subjects from research risk, reliability/Integrity of the data, and thereby assures internal consistency and Quality Compliance measures. Systems and Processes: Develop, implement and maintain a Quality Management System (QMS) for clinical trial team in consultation with Head Quality Compliance & Training and ensure oversight on team on quality aspect as per defined SOPs and applicable regulations. Implement and oversee the Quality Compliance procedures/processes/systems for clinical trials managed by the Medical science and Clinical Operations department. To assist in designing a process to write, review and approve the risk assessments for new trials and for ongoing projects and working closely with Project Managers and Operation Head as needed. To ensure a process in place to provide assurance on review of all study documentation for accuracy, consistency and completeness. Ensure effective systems and processes in place to maintain consistency and quality compliance parameters in medical science, operations, data management and drug depot for end-to-end activities of each function as per applicable regulatory requirements. Work with Clinical Research QC team, Medical Science team, Clinical Operations team, Clinical Data Management team and Study Management team to create and implement study specific QC plans that outline the scope of Quality Compliance procedures to be followed during clinical trials, ensuring QC processes are in alignment with SOPs and study protocols. Ensure completeness of training of study team on SOPs and job specific training as per role and responsibilities. Ensure periodic review of training files for all study team. Assess and identify the training requirement of study team and ensure completion of training. Well versed with electronic systems used in Clinical Trial operations, Data Management and Project Management which includes project specific deliverables tracking and important milestone related alarms, protocol compliance tracking, deviations tracking and electronic systems used for managing Trial Master File (TMF) and Drug accountability. Assist in developing system/process to work with the clinical trial team to schedule pre-execution and post-execution QC activities to ensure that all requirements of the QC plans are planned as required and executed. Plan, design, and update process and systems for clinical trial activities like development and utilization of QC assessment parameters and other QC tools designed to document/track the QC review process for clinical research activities in line with recent regulatory requirement. Ensure Quality Management System at Medical Science, Data Management team, Operation team to ensure the department is ready for audit/inspection 24x7. Ensure periodic review of Vendors and renewals as per applicable policies & procedures. Identify and recommend process improvement initiatives where required. Create and evaluate metrics to assess performance and implement plans for course correction. Activities: Should be effective team player who can work closely with different study teams and collaborate well with team members to achieve defined QC targets. Develop and implement a risk-based and flexible approach to Quality Compliance (QC) within the function, which will ensure that trial participants and data are safeguarded in compliance with applicable regulatory requirements and best practices. Identify and decide team members job specific SOP training requirements in view of their role and maintain oversight of training to ensure all team members are trained on each SOP as required. Preparation of SOPs related to QC function and support in review of SOPs specific to Medical science, Clinical team and Data Management team. Quality review of the clinical trial medical science related activities like Synopsis, Protocol, Clinical Study Report (CSR) and appendices, and SOPs in line with ICH GCP requirement, Indian and global regulatory requirement. Quality review of the clinical trial operation related activities, related tools, plans and documentation like site feasibility, site selection visit, site initiation, Ethic committee documentation, monitoring site specific reports, Site Documents, logs and close out activities in line with ICH GCP requirement, Indian and global regulatory requirement. Ensure Quality review of SOPs and oversight on quality parameters specific to Clinical Trial Supply Management (CTSM) and other activities like receipt, handling of study sample, labelling, storage, temperature monitoring systems and distribution to trial sites. Final QC review of study close out activities including returned goods reconciliation, inventory destruction processing and archiving of documents. Review and communication of QC findings to respective department in stipulated timelines. Arrange monthly meeting or meetings as and when required depending on criticality of the issues with concerned team to discuss and communicate the findings from QC reviews to the internal stakeholders via QC summaries, reports as required. Maintain the repository of QC findings as per the department and specific function and present the trend analysis, training requirement and action plan with timelines to Head Medical Affairs and clinical for course correction on quarterly basis. Ensure training of SOPs, on job training and reviewing training files on regular basis. QC review and Support in preparation of clinical study manuals/documents/Plan such as the IMP handling manual, Study plans. Ensure record maintenance for all activities for traceability in line with regulatory requirement. WHO YOU ARE: > 5 years experience in a CRO/Pharma/Biotech organization in Quality department with experience of Quality activities in Clinical Research department. Strong eye for detail and ability to spot inconsistencies a must and good conflict management skills. Must have experience in handling audits & inspections of DCGI, US FDA. Thorough knowledge of recent GCP guidelines, ICMR guidelines, Drugs and Cosmetic Act regulations and other applicable regulations pertaining to clinical trials. Experience of working in matrix business environments preferred. Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards. Quality oriented mindset and skill set. Experience in auditing processes and procedures, including the development of plans for corrective and preventive action (CAPA). In-depth working knowledge of clinical trial regulations, good clinical practice (GCP) guidelines and other frameworks, and their implications for clinical research. Proactive approach to reviewing, updating and improving processes based on current knowledge of the regulatory requirements. Have strong analytical and problem-solving skills and the ability to present solutions. Able to work under pressure and prioritize workload effectively, able to ensure timely completion of tasks to high quality in a matrix organization. Eye for details, Sense of urgency & desire to excel. Proficiency with Excel or other quality management systems/ tools. Result oriented and performance driven. Excellent interpersonal & communication skills to effectively interact with a broad range of audience. Job location: Sun House, Goregaon East, Mumbai

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6.0 - 11.0 years

15 - 20 Lacs

Hyderabad

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The TechLilly Automation Strategy and Operations team is seeking to add a technical lead er r ole to the team. This role will have an engineering focus and help drive the strategic architecture and technology direction for the team across key capabilities of automation within Lilly s Automation Center of Excellence. Are you innovative and curious about new technology that can make business processes easy and more efficient? Come join our team! What you'll Be Doing: In this position, you will impact the way automation is delivered across the company. To do this, you will Lead and Manage Automation Initiatives : Oversee the design, development, and implementation of automation solutions to streamline IT operations, ensuring high availability, scalability, and performance. Team Leadership and Collaboration : Mentor and guide a team of automation engineers, while collaborating with cross-functional teams to identify automation opportunities and resolve technical challenges. Continuous Improvement and Support : Drive continuous improvement by proactively monitoring systems, addressing incidents, and optimizing existing automation frameworks to enhance operational efficiency and reduce manual effort. How you'll Succeed: Develop a deep technical understanding of automation solutions and Industry best practices . Learn the spectrum of automation capabilities and industry leading technical platforms to implement change in the automation ecosystem to stay current and deliver automation value at speed and scale to our business partners. A lign people, tools, and process es to enable rapid automation solution delivery , and identify opportunities for automation reuse and self-service across the enterprise. Continuously e valuate a utomation tools /technologies . Understand the current automation technology landscape and the breadth of functionality available . After l ead ing the automation technology evaluation process and selection , you will lead the implementation of bringing the technology in to the environment, including the strategy for reusable templates and APIs for automation consumption. Lead the automation platform architecture operations, ensuring that all automation technologies are stable, secure, performant, compliant, resilient, and reliable for usage at scale . Lead the development of an integration strategy , including use of connectors and APIs to accelerate delivery and to be consumed by both the business and the internal team . Develop and maintain an improved automation metric s and KPI strategy, including definition s, measurement s, automated notifications, and dashboards/visualizations tracking the teams internal service delivery as we'll as business specific KPIs . Collaborate with the delivery team to anticipate demand and incorporate new capabilities and technologies into the enterprise automation portfolio. Collaborate across frontend, backend, DevOps, and delivery teams to ensure seamless API performance and reliability, anticipate demand, and introduce new capabilities into the automation portfolio. What You Should Bring: Experience as a technical leader , influencing strategic direction and driving implementation of multiple technical projects, systems, and applications . Demonstrated agility to rapidly understand new technologies and the infrastructure/ architectures to support them, deep understanding of hybrid cloud and cloud native architectures, integration strategies, and security to assess value, and to capture core use cases. Proven relationship building skills and ability to lead, influence and support a diverse technical team through operational improvement and change . Ability to work collaboratively across and within diverse teams and organizational levels . Successful record of high-quality , technical application project delivery with demonstrated quantified business value , tracking and lessons learned . Ability to create strategic technology - related business cases to enable efficiency gains, growth , scale and change for complex technical delivery services. Excellent analytical, problem solving and communication skills . A high level of intellectual and technical curiosity, open to continuous improvement and ability to drive innovation within the team . Experience using project delivery frameworks and methodologies such as Agile Scrum, Kanban, SAFe , etc. and demonstrated experience in industry best practices and automation tools. Basic Qualifications: Bachelor s Degree in Computer Science , Information Technology or related technical fiel d plus a minimum of 6 years of experience in application solution delivery and leading others in technical p rojects OR High School Diploma/GED plus a minimum of 8 years of experience in application solution delivery and leading others in technical projects A minimum of 4 years demonstrating technical expertise in solution architecture . development, and delivery. Automation related experience is a plus. A minimum of 5 years of programming experience, ideally in one of the following languages (Python, JavaScript Frameworks -NodeJS, Angular, React, etc.) Deep e xpertise in e nd-to-end DevOps (Jira, GitHub, GitHub Action, CI/CD)

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1.0 - 3.0 years

1 - 3 Lacs

Ahmedabad

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Comply with World Courier Standard Operating Procedures (SOP), which contain specific instructions to take the steps concerning the reception and shipment of materials Compare the material received with the documentation forwarded in order to certify concordance or disagreement Prepare box contents according to what s described on WC Packing List The Operator must have the training and the capability required to control materials characteristics (described in their labels): ID number, expiration date, patient s kit, and temperature and storage conditions as we'll as any additional information that could be useful The Operator must be specifically trained in order to perform activities related to shipments such as the packaging preparation, box closing and labeling Perform activities on the Operative System CTM-STAR related to the Inbound, Outbound, Return and Relocation processes Have deep knowledge and carry out relabeling, stock, balance and relocations processes developed at the Facility Perform any other duties the employee has been trained for Requirements: English language - B2-C1 Gujarati language - native - C1 Experience in logistics /warehouse/operations - will be a plus Computer skills Adaptability to working hours: Monday to Saturday Good communication skills Pleasant proactive manner Attention to detail Initiative and commonsense Reliable and accountable Ability to work in a team environment

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0.0 - 1.0 years

2 - 5 Lacs

Bengaluru

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Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: Bachelor of Physiotheraphy Years of Experience: 0 to 1 years 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 You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create 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 Junior Drug Safety AssociateJunior Drug Safety Associate Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Physiotheraphy

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5.0 - 9.0 years

22 - 27 Lacs

Mumbai

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YOUR TASKS AND RESPONSIBILITIES: Core scientific member of cross-functional franchise team and a disease area expert, responsible for scientific enablement of respective business cluster Conceptualization and project management of wide range of medical activities that are aligned to the respective franchise strategy like: New Product Ideation New Product Evaluation Therapeutic rationale relevant Medical support for regulatory submissions Preparation of SEC presentations defense in SEC meeting Pre-launch launch preparations including product monograph, training manuals, training CME slides Franchise Medical Education programs Promotional and non-promotional material review approval Answering queries Marketing and Sales training Real World Clinical Research and Publications - Planning and Execution Advisory board meetings Developing Insight driven Medical Plans Interaction Engagement of identified Key Opinion leaders in a peer-to-peer capacity through medical affairs activities, in alignment with the overall strategic plan to shape disease areas of interest A therapeutic area scientific expert, responsible for discussing the scientific data pertaining to products on proactive and reactive basis, obtain insights into patients treatment trends and insights in the disease areas of interest and to be considered a trusted scientific counterpart Responsible for identifying knowledge gaps, practice gaps and data gaps and provide recommendations for devising medical product education programs, evidence generation and special projects Ability to convert insights on disease trends and treatment patterns from KOLs into viable and formidable solutions to shape the therapeutic areas of interest Devise optimal training plan to ensure flow of latest medical developments in the given to sales marketing team Jointly responsible with marketing teams to support optimal patient outcomes through communication of data, information, and insights to shape disease areas of interest Represent the organization in various internal external scientific platforms Collaborate with thought leaders to conduct therapy specific reviews, meta-analysis, case studies, case series, patient reported outcomes and publish them in journals of repute Receiving and processing scientific information requests received from physicians internal stakeholders Ability to handle complex questions from health care professionals related to company products or disease area to satisfaction Responsible for ensuring that all promotional materials are approved within stipulated timelines and in alignment with company approval process Conduct of robust medical evaluation of new products through thorough desk research and interactions with KOLs WHO YOU ARE: Education: MD (Pharmacology) Experience: 3+ years working experience in the pharmaceutical industry or research company in a capacity of HO Medical Advisor or Sr. Medical Advisor Training in medical writing, clinical trial methodologies, research design and ICH - GCP will be added advantage Must have working knowledge of Indian regulations pertaining to Health care professionals interactions (MCI code of ethics for doctors UCPMP Code for Pharma) and Drugs and Cosmetic Act regulations pertaining to clinical trials and new drug approvals Strong academic record with deep knowledge of the therapeutic area, strength in research with knowledge of research methodologies and interpretation of medical data Strategic mindset with scientific acumen and communication skills in order to be accepted by leading specialists in peer-to-peer capacity Experience with complex business environments preferred Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and award Job Location: Sun House, Goregaon East, Mumbai

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5.0 - 9.0 years

22 - 27 Lacs

Mumbai

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YOUR TASKS AND RESPONSIBILITIES: Core scientific member of cross-functional franchise team and a disease area expert, responsible for scientific enablement of respective business cluster Conceptualization and project management of wide range of medical activities that are aligned to the respective franchise strategy like: New Product Ideation New Product Evaluation Therapeutic rationale relevant Medical support for regulatory submissions Preparation of SEC presentations defense in SEC meeting Pre-launch launch preparations including product monograph, training manuals, training CME slides Franchise Medical Education programs Promotional and non-promotional material review approval Answering queries Marketing and Sales training Real World Clinical Research and Publications - Planning and Execution Advisory board meetings Developing Insight driven Medical Plans Interaction Engagement of identified Key Opinion leaders in a peer-to-peer capacity through medical affairs activities, in alignment with the overall strategic plan to shape disease areas of interest A therapeutic area scientific expert, responsible for discussing the scientific data pertaining to products on proactive and reactive basis, obtain insights into patients treatment trends and insights in the disease areas of interest and to be considered a trusted scientific counterpart Responsible for identifying knowledge gaps, practice gaps and data gaps and provide recommendations for devising medical product education programs, evidence generation and special projects Ability to convert insights on disease trends and treatment patterns from KOLs into viable and formidable solutions to shape the therapeutic areas of interest Devise optimal training plan to ensure flow of latest medical developments in the given to sales marketing team Jointly responsible with marketing teams to support optimal patient outcomes through communication of data, information, and insights to shape disease areas of interest Represent the organization in various internal external scientific platforms Collaborate with thought leaders to conduct therapy specific reviews, meta-analysis, case studies, case series, patient reported outcomes and publish them in journals of repute Receiving and processing scientific information requests received from physicians internal stakeholders Ability to handle complex questions from health care professionals related to company products or disease area to satisfaction Responsible for ensuring that all promotional materials are approved within stipulated timelines and in alignment with company approval process Conduct of robust medical evaluation of new products through thorough desk research and interactions with KOLs WHO YOU ARE: Education: MD (Pharmacology) Experience: 3+ years working experience in the pharmaceutical industry or research company in a capacity of HO Medical Advisor or Sr. Medical Advisor Training in medical writing, clinical trial methodologies, research design and ICH - GCP will be added advantage Must have working knowledge of Indian regulations pertaining to Health care professionals interactions (MCI code of ethics for doctors UCPMP Code for Pharma) and Drugs and Cosmetic Act regulations pertaining to clinical trials and new drug approvals Strong academic record with deep knowledge of the therapeutic area, strength in research with knowledge of research methodologies and interpretation of medical data Strategic mindset with scientific acumen and communication skills in order to be accepted by leading specialists in peer-to-peer capacity Experience with complex business environments preferred Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and award Job Location: Sun House, Goregaon East, Mumbai

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0.0 - 1.0 years

6 - 7 Lacs

Mumbai

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Job Summary: This role will responsible for preparation of clinical high-quality protocol, investigator brochures, regulatory documents, data review, clinical study report, publications, and related clinical documents. Manuscript writing, poster/abstract preparation for conferences, co-ordinate with vendors for out-sourced activities and assist for procurement of scales. YOUR TASKS AND RESPONSIBILITIES: Systems and Processes: Ensure to follow all clinical and regulatory guidelines, processes and systems for medical science activities and ensure compliance to internal medical writing SOPs for Clinical trial To follow the designed process to write, review protocol for new trials and work closely with operation team to ensure high quality operationally feasible protocol for clinical trial To co-ordinate with a process for review of all study synopsis from clinical, regulatory and operational perspective Prepare and review SOPs specific for medical writing for clinical trial Work closely with medical monitors for review of study documents (such as statistical analysis plan, data monitoring plan, coding plan, CRF) and data review activities Identify, recommend and lead process improvement initiatives Create and evaluate metrics to assess performance and implement plans for course correction Well versed with systems (MedDRA and WHO-DD) for data coding including coding of adverse events and drugs Good knowledge of different randomization procedures and different blinding techniques to be used in clinical trials Identify, recommend and lead process improvement initiatives Create and evaluate metrics to assess performance and implement plans for course correction. Activities: Responsible for clinical trial medical science related activities like preparation of protocol, Clinical Study Report (CSR) and appendices, and SOPs in line with ICH GCP requirement, Indian and global regulatory requirement Conduct relevant literature search for required for protocol, CSR, and manuscript writing Responsible for writing clinical journal manuscripts, clinical journal abstracts, and study article for publication Responsible for preparation of protocol and clinical study reports presentation in subject s expert committee (SEC) regulatory meeting Responsible for collaboration with vendors for manuscript writing, abstract/poster preparation, procurement of clinical scales/PROs (Patient reported Outcomes) Responsible for coordination with data management team to ensure timely review of data extract and data cleaning activities to ensure timely database lock and release of tables, figures, and listings (TLFs) Responsible for coordinating with biostatistician to engage early with the study team for sample size certificate, review of statistical analysis plan (SAP) apart from review of mock and/or blinded tables, figures, and listings (TFLs), and narrative and discussion planning for relevant documents in co-ordination with medical monitor Responsible for registering on clinical trials registries (e. g. CTRI) Ensures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines Creates and maintains standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables Ensures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines Creates and maintains standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables Responsible for mentoring and leads less experienced medical writers on complex projects, as necessary WHO YOU ARE: B. Pharma/M. Sc/M. Pharma/PhD/BAMS/BHMS/life sciences educational background 0-1 years of relevant medical writing experience Excellent medical writing skills Well versed with different guidelines such as IMRAD, CONSORT and different publication guidelines Well versed with different guidelines such as IMRaD, CONSORT and relevent publication guidelines Well versed with current GCP/GDP regulations Thorough knowledge of GCP guidelines, ICMR guidelines 2017 and Drugs and Cosmetic Act regulations pertaining to clinical trials and other regulatory guidelines like FDA Experience of working in matrix business environments preferred Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards Strong medical knowledge of different therapeutic area Sound functional knowledge of clinical research and medical writing activities Collaboration and teaming with ability to work in a matrix environment Strategic thinking sound analytical skills Good writing and communication skills Sense of urgency desire to excel Proficiency with Excel or software statistical tools. Self-awareness and adaptability to work in a matrix environment Result oriented and performance driven Excellent interpersonal communication skills to effectively interact with a broad range of audience Job location: Sun House, Goregaon East, Mumbai

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1.0 - 3.0 years

1 - 4 Lacs

Chennai, Thiruvananthapuram

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Imaging Support Specialist _ Office Based ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking an Imaging Support Specialist to join our diverse and dynamic team. As an Imaging Support Specialist at ICON, you will play a vital role in providing technical support and assistance for imaging operations within clinical trials. You will ensure that imaging processes run smoothly, facilitating effective communication and coordination among teams and stakeholders. What You Will Be Doing: Providing day-to-day technical support for imaging systems and processes, troubleshooting issues as they arise. Assisting in the setup and maintenance of imaging equipment, ensuring compliance with safety and regulatory standards. Collaborating with clinical teams to ensure proper execution of imaging protocols and adherence to study timelines. Training staff on imaging procedures, software, and best practices to optimize workflow and data quality. Maintaining accurate records of imaging data, system performance, and support requests to facilitate continuous improvement. Your Profile: Bachelor s degree in medical imaging, radiologic technology, or a related field; relevant certifications preferred. 1-3 years of experience in imaging support or a related role, ideally within a clinical research setting. Strong technical skills and familiarity with imaging equipment and software. Excellent problem-solving abilities, with attention to detail and a proactive approach to support. Strong communication and interpersonal skills, with the ability to work effectively in a team-oriented environment. What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

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1.0 - 3.0 years

3 - 6 Lacs

Chennai, Thiruvananthapuram

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Imaging Support Specialist _ Office Based We are currently seeking an Imaging Support Specialist to join our diverse and dynamic team. As an Imaging Support Specialist at ICON, you will play a vital role in providing technical support and assistance for imaging operations within clinical trials. You will ensure that imaging processes run smoothly, facilitating effective communication and coordination among teams and stakeholders. What You Will Be Doing: Providing day-to-day technical support for imaging systems and processes, troubleshooting issues as they arise. Assisting in the setup and maintenance of imaging equipment, ensuring compliance with safety and regulatory standards. Collaborating with clinical teams to ensure proper execution of imaging protocols and adherence to study timelines. Training staff on imaging procedures, software, and best practices to optimize workflow and data quality. Maintaining accurate records of imaging data, system performance, and support requests to facilitate continuous improvement. Your Profile: Bachelor s degree in medical imaging, radiologic technology, or a related field; relevant certifications preferred. 1-3 years of experience in imaging support or a related role, ideally within a clinical research setting. Strong technical skills and familiarity with imaging equipment and software. Excellent problem-solving abilities, with attention to detail and a proactive approach to support. Strong communication and interpersonal skills, with the ability to work effectively in a team-oriented environment. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

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4.0 - 9.0 years

6 - 11 Lacs

Hyderabad

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A Day in the Life This role is responsible for CASE (CASE is a global adjudication tool that harmonizes the adjudication process and houses the data in a single global tool. The tool is designed for end users to configure new studies and corresponding rules of the adjudication and for adjudicators to capture their responses. ) application development. There are periodic releases, which consist of making changes to the existing functionality or adding enhancements. This role is responsible for Development (including GUI design, if required), system design, documentation, coding, and testing/debugging applications. This is critical application for Clinical Trials and is home grown. We must build the development capabilities within MDT, so we can support this app long term. Responsibilities may include the following and other duties may be assigned. Responsible for configuration & Implementation work that focuses on programming and configuration of an Enterprise Resource Planning (ERP) application that is integrated with business processes/data and IT infrastructure (i.e. an application system ). Includes Building and developing application tables/panels/reports, and coding individual modules and complex functions for a client/server enterprise application. Integrating software, developing external interfaces, and maintaining technical documentation. Designing and developing most aspects of data conversion. Troubleshooting and resolving testing issues. For example - Mobile, Web, iOS development. TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies - from design to implementation - while adhering to policies, using specialized knowledge and skills. DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others work product. Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a Baccalaureate Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience. (For degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. 214.2(h)(4)(iii)(A)). About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission to alleviate pain, restore health, and extend life unites a global team of 95,000+ passionate people. We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here

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1.0 - 6.0 years

3 - 7 Lacs

Pune

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Preparing interview questions, communicating and interacting with patients,and summarizing results. Liaising with laboratories regarding research findings. Monitoring the study to ensure that it complies with protocols. Directing the collection, labelling, storage, and transport of all specimen. Noting the clinical data from records, recording dietary intake patterns, physical activity, sample separation, and patient follow-up. Analyze data using various statistical methods and maintain accurate and complete records. Co-ordinate with Bioinformaticians, Genetic Counselors, Clinicians, and clinical geneticists for data analysis. Reviews and processes orders for laboratory procedures for patient samples. Demonstrate strong scientific and communication skills. Maintain precise and up-to-date documentation of the ethics, biosafety committee, and DSIR. Overseeing the trouble-free running of patient's enrolment for research studies. M.Sc./B.Sc. in life science (Biotechnology/Medical Microbiology / Microbiology / Medical Biochemistry) Minimum of 1 year work experience for M.Sc./B.Sc., and expertise in counseling patients and dry lab techniques.

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1.0 - 6.0 years

0 - 3 Lacs

Pune, Bengaluru, Mumbai (All Areas)

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TCS is hiring for Medical Monitor!!! Job Location Mumbai/Pune/Bangalore Experience Range 1 to 6 Years Educational Qualification(s) Required MBBS/MD Interested can please share CV on babeeta.shahi@tcs.com Review protocol and provide suggestions Respond to queries/ clarifications from EC/ IRBs Answer medical questions from sites or project team Respond to queries from sites with regard to protocol Attend drug safety meetings/ external meetings Patient eligibility review Review AE/ SAEs Protocol training to site staff, CRAs etc Attend, participate/ present in investigator meetings

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1.0 - 4.0 years

3 - 6 Lacs

Pune

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At PrimeVigilance, Junior PV Officer/ PV Officers are experienced case processing team members who are expected to manage a variety of case processing and quality review activities with minimal guidance from senior team members. Responsibilities include: Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines, focusing on triage, data entry, quality review and submissions workflow steps. Reconciliation activities for all types of received reports Workflow management activities Requirements: Life science / bio medical background - healthcare related degree (chemistry, biology, biotechnology, veterinary science) Demonstrated full start to finish case processing experience and quality review exp

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5.0 - 6.0 years

20 - 25 Lacs

Chennai

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A productive, hands on programmer who applies technical knowledge and practical experience to deliver statistical programming deliverables to support assets and study teams with limited supervision early in role and independently later in role. Ensures excellence in th e programming of analysis ready datasets, tables, listings, and figures for which they are responsible Ensures adherence to high quality programming standards in their daily work. Accountable for the quality and timely delivery of datasets and displays required for their clinical study reports as well as other asset level deliverables they may be programming. Ensures appropriate documentation and QC across the lifespan of the study for all of their programming deliverables. Exhibi ts routine and occasionally complex problem solving skills, seeking direction when appropriate. Works with statisticians and programming leads to ensure clear specifications for their programmed deliverables are in place. Will be knowledgeable in core safe ty standards as well as TA standards pertinent to their project, may aid in development of standards necessary for their study May contribute to department level initiatives. QUALIFICATIONS Bachelor or Master (prefer red) Degree in Statistics, Biological Sciences, IT, or related field. At least 3 years relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency. Statistical Programming and SAS hand - on experience Clinical trials expertise with an understanding of data operations required for the reporting of clinical trial data. Good understanding of ICH and regulatory guidelines Working knowledge of clinical data and relevant data standards Work Location Assignment: Flexible Work Location Assignment: Hybrid Medical #LI-PFE

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3.0 - 8.0 years

6 - 10 Lacs

Gurugram

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The Clinical Research Monitor / CRA / Site Monitor will coordinate clinical studies and shall be responsible for study execution, monitoring, site-training and close-out. Responsibilities will include: 1. Managing execution of clinical trial projects from initiation to closeout - across multiple projects, sites and teams. 2. Managing site relationships for ensuring and securing compliance with regulations, budgets and timelines. 3. Providing operational insights for compliance with Protocol, SOPs, policies and practices. 4. Collaborating with project teams and sponsors. 5. Site qualification, contract negotiation, IRB/EC submissions, study initiation, monitoring, and site close-out. 6. Training and oversight of site staff. 7. Periodic reviews of site-level KRIs. 8. Early identification of site-level risk/issue(s) occurring during study conduct; Escalating issues to project teams. 9. Maintaining Trial Master File (TMF). 10. Coordinating study supplies, biospecimen management, and coordination with various stakeholders. 11. Data query resolutions. 12. Supporting audit readiness and preparations. 13. Preparing study progress and performance metrics. 14. Travel to investigative sites (up to 25%). Preferred candidate profile 1. Rich experience in clinical research operations and project management, preferably in global clinical trials. 2. A degree in medicine, pharmacy or life sciences. 3. In-depth understanding of clinical research regulations, industry standards and GCP. 4. Excellent verbal and written communication skills. 5. Proficiency in using MS Word & MS Excel.

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1.0 - 4.0 years

2 - 5 Lacs

Pune

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At PrimeVigilance, Junior PV Officer/ PV Officers are experienced case processing team members who are expected to manage a variety of case processing and quality review activities with minimal guidance from senior team members. Responsibilities include: Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines, focusing on triage, data entry, quality review and submissions workflow steps. Reconciliation activities for all types of received reports Workflow management activities

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1.0 - 3.0 years

18 - 19 Lacs

Mumbai

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YOUR TASKS AND RESPONSIBILITIES: Core scientific member of cross-functional franchise team and a disease area expert, responsible for scientific enablement of respective business cluster Conceptualization and project management of wide range of medical activities that are aligned to the respective franchise strategy like: New Product Ideation New Product Evaluation Therapeutic rationale relevant Medical support for regulatory submissions Preparation of SEC presentations defense in SEC meeting Pre-launch launch preparations including product monograph, training manuals, training CME slides Franchise Medical Education programs Promotional and non-promotional material review approval Answering queries Marketing and Sales training Real World Clinical Research and Publications - Planning and Execution Advisory board meetings Developing Insight driven Medical Plans Interaction Engagement of identified Key Opinion leaders in a peer-to-peer capacity through medical affairs activities, in alignment with the overall strategic plan to shape disease areas of interest A therapeutic area scientific expert, responsible for discussing the scientific data pertaining to products on proactive and reactive basis, obtain insights into patients treatment trends and insights in the disease areas of interest and to be considered a trusted scientific counterpart Responsible for identifying knowledge gaps, practice gaps and data gaps and provide recommendations for devising medical product education programs, evidence generation and special projects Ability to convert insights on disease trends and treatment patterns from KOLs into viable and formidable solutions to shape the therapeutic areas of interest Devise optimal training plan to ensure flow of latest medical developments in the given to sales marketing team Jointly responsible with marketing teams to support optimal patient outcomes through communication of data, information, and insights to shape disease areas of interest Represent the organization in various internal external scientific platforms Collaborate with thought leaders to conduct therapy specific reviews, meta-analysis, case studies, case series, patient reported outcomes and publish them in journals of repute Receiving and processing scientific information requests received from physicians internal stakeholders Ability to handle complex questions from health care professionals related to company products or disease area to satisfaction Responsible for ensuring that all promotional materials are approved within stipulated timelines and in alignment with company approval process Conduct of robust medical evaluation of new products through thorough desk research and interactions with KOLs WHO YOU ARE: Education: MD (Pharmacology) Experience: 1-3 years working experience in the pharmaceutical industry or research company in a capacity of HO Medical Advisor or Sr. Medical Advisor Training in medical writing, clinical trial methodologies, research design and ICH - GCP will be added advantage Must have working knowledge of Indian regulations pertaining to Health care professionals interactions (MCI code of ethics for doctors UCPMP Code for Pharma) and Drugs and Cosmetic Act regulations pertaining to clinical trials and new drug approvals Strong academic record with deep knowledge of the therapeutic area, strength in research with knowledge of research methodologies and interpretation of medical data Strategic mindset with scientific acumen and communication skills in order to be accepted by leading specialists in peer-to-peer capacity Experience with complex business environments preferred Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and award Job Location: Sun House, Goregaon East, Mumbai

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3.0 - 5.0 years

1 - 5 Lacs

Nagapattinam

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We are looking for a skilled professional with 3 to 7 years of experience to join our team as an Area Receivable Manager - MF in Equitas Small Finance Bank Ltd, located in the BFSI industry. Roles and Responsibility Manage and oversee the receivables process for efficient cash flow. Develop and implement strategies to reduce delinquencies and improve collection rates. Collaborate with cross-functional teams to resolve customer issues and enhance service quality. Analyze financial data to identify trends and areas for improvement in the receivables process. Ensure compliance with regulatory requirements and internal policies. Lead and motivate a team to achieve business objectives and goals. Job Minimum 3 years of experience in a related field, preferably in BFSI or finance. Strong knowledge of financial regulations and laws governing the BFSI sector. Excellent leadership and management skills, with the ability to motivate teams. Strong analytical and problem-solving skills, with attention to detail. Effective communication and interpersonal skills, enabling strong relationships with customers and stakeholders. Ability to work in a fast-paced environment and adapt to changing priorities.

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1.0 - 5.0 years

1 - 3 Lacs

Vijayawada, Eluru, Bhimavaram

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We are looking for a highly skilled and experienced Receivable Executive to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 1-5 years of experience in the BFSI industry. Roles and Responsibility Manage and maintain accurate records of receivables, including invoices, payments, and outstanding balances. Develop and implement effective strategies to improve cash flow and reduce delinquencies. Collaborate with cross-functional teams to resolve customer complaints and disputes. Analyze financial data to identify trends and areas for improvement in receivable management. Ensure compliance with regulatory requirements and internal policies related to receivables. Provide excellent customer service to clients, responding promptly to their queries and concerns. Job Requirements Strong knowledge of accounting principles, financial regulations, and banking practices. Excellent communication, interpersonal, and problem-solving skills. Ability to work in a fast-paced environment with multiple priorities and deadlines. Proficiency in MS Office and other relevant software applications. Strong analytical and organizational skills with attention to detail and accuracy. Experience working with receivables, including invoicing, payment processing, and collections.

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5.0 - 8.0 years

1 - 3 Lacs

Pallavaram, Chennai, Kanchipuram

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We are looking for a skilled Branch Receivable Officer to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 5 years of experience in the BFSI industry. Roles and Responsibility Manage and oversee the branch's receivable portfolio, ensuring timely payments and minimizing bad debts. Develop and implement effective strategies to improve cash flow and reduce outstanding amounts. Collaborate with the collections team to resolve customer issues and enhance overall customer satisfaction. Analyze financial data to identify trends and areas for improvement in the bank's receivable operations. Maintain accurate records and reports on receivables, including aging analysis and credit risk assessments. Ensure compliance with regulatory requirements and internal policies related to receivables management. Job Requirements Strong knowledge of accounting principles, financial regulations, and banking practices. Excellent communication, interpersonal, and problem-solving skills. Ability to work effectively in a fast-paced environment and meet deadlines. Proficiency in MS Office and other relevant software applications. Strong analytical and decision-making skills with attention to detail. Experience working in a similar role within the BFSI industry is preferred.

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5.0 - 7.0 years

1 - 3 Lacs

Pudukkottai, Aranthangi, Tiruchirapalli

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We are looking for a skilled Branch Receivable Officer to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 5-7 years of experience in the BFSI industry. Roles and Responsibility Manage and oversee the branch's receivable portfolio, ensuring timely payments and minimizing bad debts. Develop and implement strategies to improve cash flow and reduce outstanding amounts. Collaborate with the collections team to resolve customer issues and enhance credit quality. Analyze financial data to identify trends and areas for improvement in the bank's receivables. Maintain accurate records and reports on receivables, including aging analysis and delinquency tracking. Ensure compliance with regulatory requirements and internal policies related to receivables management. Job Requirements Strong knowledge of accounting principles, financial regulations, and banking practices. Excellent analytical, problem-solving, and communication skills. Ability to work effectively in a fast-paced environment and meet deadlines. Proficiency in MS Office and other relevant software applications. Strong attention to detail and organizational skills, with the ability to prioritize tasks and manage multiple projects simultaneously. Experience working in a similar role within the BFSI industry, preferably in a banking or finance setting.

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3.0 - 4.0 years

1 - 3 Lacs

Kurnool

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We are looking for a skilled Branch Receivable Officer to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 3-4 years of experience in the BFSI industry. Roles and Responsibility Manage and oversee the daily operations of the branch receivables function. Develop and implement strategies to improve collection efficiency and reduce delinquencies. Collaborate with internal stakeholders to resolve customer complaints and issues. Analyze and report on key performance indicators related to receivables management. Ensure compliance with regulatory requirements and company policies. Provide training and guidance to junior staff members. Job Requirements Strong knowledge of financial regulations and laws governing the BFSI sector. Excellent communication and interpersonal skills for effective stakeholder interaction. Ability to work in a fast-paced environment and meet deadlines. Strong analytical and problem-solving skills to resolve complex issues. Proficiency in Microsoft Office and other relevant software applications. Experience working in a similar role within the BFSI industry is preferred.

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