622 Clinical Trials Jobs - Page 3

We are seeking Pharmacy Freshers With Quality Assurance Training to ensure our products meet the highest standards of quality and safety. Responsible for preparation and review of SOPs, Protocols, and other cGMP documents. Required Candidate profile Pharmacy Freshers with Training in Quality Assurance or Exp as QA/QC from Pharma Industry, Exp in Compliance, Documentation, protocols, reports.

Create eCRF specifications, design, develop and unit test and functionally validate clinical trial setup process Create edit check specifications and program or modify checks at study level within EDC Setup different instances of study URL (e.g.: UAT (User Acceptance Testing), production, testing etc.,) Setup and configure user accounts for study teams Setup and manage blinded and unblinded study configurations Be the SME (Subject Matter Expert) for all database related activities Setup, configure, unit test and functionally validate and integrate other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc., Familiar with custom functions within EDC systems Work closely with EDC vendors regarding any tool related issues in the system Ability to troubleshoot database setup as per study needs Prepare, test and implement postproduction changes as per study needs Archive and retire the study URL after database lock Partner with appropriate team members to establish technology standards and governance models Establish and support business process SOPs. Oversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT (Information Technology), and Quality organizations Be a primary change agent to ensure adoption of new capabilities and business process Be the contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of quality. Work with leaders to resolve issues affecting the delivery of clinical trials Collaborate with standards team in creating standard CRF libraries for study level consumption Work closely with data engineers and data management programmers at study level integration and delivery Lead technology vendor oversight activities. Be a process expert for operational and oversight models.

Create eCRF specifications, design, develop and unit test and functionally validate clinical trial setup process Create edit check specifications and program or modify checks at study level within EDC Setup different instances of study URL (e.g.: UAT (User Acceptance Testing), production, testing etc.,) Setup and configure user accounts for study teams Setup and manage blinded and unblinded study configurations Be the SME (Subject Matter Expert) for all database related activities Setup, configure, unit test and functionally validate and integrate other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc., Familiar with custom functions within EDC systems Work closely with EDC vendors regarding any tool related issues in the system Ability to troubleshoot database setup as per study needs Prepare, test and implement postproduction changes as per study needs Archive and retire the study URL after database lock Partner with appropriate team members to establish technology standards and governance models Establish and support business process SOPs. Oversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT (Information Technology), and Quality organizations Be a primary change agent to ensure adoption of new capabilities and business process Be the contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of quality. Work with leaders to resolve issues affecting the delivery of clinical trials Collaborate with standards team in creating standard CRF libraries for study level consumption Work closely with data engineers and data management programmers at study level integration and delivery Lead technology vendor oversight activities. Be a process expert for operational and oversight models.

Need exposure to Inform or Medidata Rave database Responsible & Accountable for the assigned study conduct activities, in clinical trials Validate clinical trial data to ensure consistency, integrity, and accuracy based on project-specific guidelines. Generate data queries based on validation checks or raise Manual queries to resolve data inconsistencies. To perform reconciliation of data from external sources (e.g. Serious Adverse Events, IWRS, Central Laboratory). SPOC for the study communications Proactively highlight any risks associated with the study along with the mitigation plan. Establish a partnership with the stakeholders at the operational level to work seamlessly to deliver the assigned project/activity as per timelines. Identify process Improvement opportunities and ensure learning is shared Ensure deliverables and/or agreed activities/tasks with customers. are completed with the expected quality. Have worked on Study set-up, Study Conduct, and Study Closeout for various therapeutic areas. Have also worked on writing edit check specifications, CRF completion guidelines, and review and corrections of set-up documents for different versions

To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation Aggregate Safety Reports (PBRER, DSUR etc.) Eligibility: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) Working knowledge of MS Office applications Flexibility to work as per business requirements. Understands and interprets data/information and its practical application. Knowledge of industry and business principles related to biopharmaceutical products and combination products. Good interpersonal, verbal, and written communication skills

Role & responsibilities: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic Aggregate Safety Reports (PBRER, DSUR etc.). To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation.

SAS MACROS Pan India One of the leading Lifescience company in India mail at manjeet.kaur@mounttalent.com Whatsapp at 8384077438 Experience Required : 7 to 10 Years of experience 1)Primarily responsible for quality and timely delivery of SDTM and ADaM artifacts (Specifications, datasets, cSDRG, ADRG) and TFLs 2) Read and understand Clinical study protocol, Statistical Analysis Plan, Case Report Form (CRF), specifications and other study related documents. 3) Develop SAS programs to produce Analysis datasets, statistical tables, graphical representations, and data listings for individual study reports in accordance with the Statistical Analysis Plan (SAP) 4) Develop validation programs to validate outputs produced by other team members and perform validation on program code of other team members. 5) Provide support to Data Management in developing Edit check programs, listings or ad hoc reports as required 6) Develop, Debug Utility macros for reusability and efficiency Skill Set - 1)Experience working on ADAM and TFL deliverables on multiple therapeutic areas and phases in clinical trials. 2) Experience creating and working with Utility Macros 3) Experience creating specifications 4) Experience with CDSIC standards including CDASH or SDTM/ADaM 5) Ability to work independently and as part of a team 6) Being open to new learnings and sharing with team members 7) Excellent communication skills [Written, Verbal, Interpersonal and organizational skills] 8) Proficient in using SAS EG/Studio for programming 9) Familiar with Unix environment and programming 10) Prior working experience in Vaccines or Oncology is an added advantage 11) Familiarity with multiple statistical procedures and functions to create TFLs

About The Role Credit Card Process Manager Marketing HO Department Credit Card Products Location Infiniti IT park Reporting Relationship Position Grade Senior Manager Job Role Process designing for Credit Cards covering key aspects of Process Workflows (Digital / Physical), Compliance, Risk, Legal, Ops, Customer Experience, etc. Creating and documenting SOPs/Process notes of various Credit Card processes with clear defined roles and responsibilities to promote efficient implementation. Ability to think through end to end process at various touchpoints such as online channels, partners, Branches, Call center etc. Review processes in light of Fraud and Risk raised by RCU and ORM. Identification of Risks and Regulatory breach on cards processes and provide solution to mitigate risks and control reports to minimize process lapses. Monitor and govern if the defined processes are being executed from time to time, including regulatory changes In-depth understanding of KYC and Other Regulatory Guidelines. Providing tailor made solution to Product / Operations for specific business requirement. Ideate & suggest Product and Operations with end to end execution of a Process / Digital Journey"™s / new initiatives / features etc. Ensuring the Digital Journey controls and logics is in line with defined Process, Regulation and Risk perspective Responsible for the documentation of Business Processes, workflows. Publish MIS and Reports Job Requirement Graduate/Post-Graduate with at least 5 to 6 years of experience in Business Processes In-depth knowledge of Credit Cards business Knowledge of Regulatory requirements and market competition/intelligence will be an added advantage. Excellent communication skills Verbal & Written Good Logical reasoning and data analysis skill Should be able to think proactively for process changes from Business Process Re-engineering perspective Assertive attitude Self-Driven and ability to follow-up promptly Good analytical skills & eye for details

Experience in Document control, formatting, handling softwares, MS Word, Excel and PPT, SOPs, WIs, policies, maintaining trackers, good communication skills, coordination with other departments and vendors. System and Project audits. Required Candidate profile Good Communication;2-4 years of experience in QA;5-8 years of experience in Clinical Research/ Pharma / CRO,

Primary Responsibilities: Review and analyze patient medical records for accurate code assignment Ensure adherence to coding guidelines and regulatory requirements Learn to use medical coding software Apply understanding of anatomy and physiology to interpret clinical documentation and identify applicable medical codes Stay updated on industry changes and attend relevant training sessions Ensure confidentiality and security of all patient information Comply with the terms and conditions of the employment contract, company policies and procedures, and any and all directives (such as, but not limited to, transfer and/or re-assignment to different work locations, change in teams and/or work shifts, policies in regards to flexibility of work benefits and/or work environment, alternative work arrangements, and other decisions that may arise due to the changing business environment). The Company may adopt, vary or rescind these policies and directives in its absolute discretion and without any limitation (implied or otherwise) on its ability to do so #NTRQ Required Qualifications: Bachelors degree or masters degree, from a medical science backdrop or anything relevant Life Science or Bioscience, Pharmacy or Pharmaceutical Sciences, Nursing or Medicine Allied Health Good knowledge in medical terminology basics Good knowledge in Anatomy physiology basics Well-versed with ICD-10 guidelines and their implementation Proficient in reviewing medical records and determining the accuracy and completeness of the document Preferred Qualifications: AAPC/AHIMA Certification Risk Adjustment coding experience At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone of every race, gender, sexuality, age, location and income deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes an enterprise priority reflected in our mission.

Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel their best. Here, you will find a culture guided by diversity and inclusion, talented peers, comprehensive benefits and career development opportunities. Come make an impact on the communities we serve as you help us advance health equity on a global scale. Join us to start Caring. Connecting. Growing together Primary Responsibilities: Review and analyze patient medical records for accurate code assignment Ensure adherence to coding guidelines and regulatory requirements Learn to use medical coding software Apply understanding of anatomy and physiology to interpret clinical documentation and identify applicable medical codes Stay updated on industry changes and attend relevant training sessions Ensure confidentiality and security of all patient information Comply with the terms and conditions of the employment contract, company policies and procedures, and any and all directives (such as, but not limited to, transfer and/or re-assignment to different work locations, change in teams and/or work shifts, policies in regards to flexibility of work benefits and/or work environment, alternative work arrangements, and other decisions that may arise due to the changing business environment). The Company may adopt, vary or rescind these policies and directives in its absolute discretion and without any limitation (implied or otherwise) on its ability to do #NTRQ Required Qualifications: Bachelors degree or masters degree, from a medical science backdrop or anything relevant Life Science or Bioscience, Pharmacy or Pharmaceutical Sciences, Nursing or Medicine Allied Health Good knowledge in medical terminology basics Good knowledge in Anatomy physiology basics Well-versed with ICD-10 guidelines and their implementation Proficient in reviewing medical records and determining the accuracy and completeness of the document Preferred Qualifications: AAPC/AHIMA Certification Risk Adjustment coding experience At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone of every race, gender, sexuality, age, location and income deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes an enterprise priority reflected in our mission.

Job Title: Sr. QA Associate / QA Associate Clinical Trials Location: Mumbai Education: B.Pharm / M.Pharm / M.Sc. / B.Sc. / Life Sciences Job Description: We are looking for a proactive and detail-oriented Sr. QA Associate / QA Associate to join our Quality Assurance team for Clinical Trials. The ideal candidate will be responsible for ensuring GCP compliance across clinical trial activities, conducting internal and external audits, and supporting regulatory inspections in alignment with ICH-GCP, applicable regulatory requirements, and sponsor expectations. Key Responsibilities: Perform internal audits (e.g., system, process, and study-specific audits). Conduct vendor audits (e.g., clinical sites, laboratories, and service providers). Review and approve SOPs, protocols, CRFs, ICFs, and other essential trial documents. Ensure compliance with ICH-GCP, CDSCO, US FDA, EMA, and other applicable guidelines. Track and manage deviations, CAPAs, and non-conformance reports. Participate in inspection readiness activities and support sponsor/regulatory audits. Maintain QA metrics and dashboards for quality tracking and reporting. Provide GCP training to internal teams and vendor staff, as needed. Collaborate with cross-functional teams (Clinical, Regulatory, Data Management, etc.). Ensure timely escalation and resolution of quality issues. Desired Candidate Profile: 2 to 6 years of QA experience in Clinical Research, preferably in a CRO environment. In-depth knowledge of GCP, ICH guidelines, and applicable local/global regulations. Experience in conducting clinical trial audits (sites, systems, vendors). Strong verbal and written communication skills. Detail-oriented, analytical, and able to manage multiple projects simultaneously. Preferred Skills: Experience in handling sponsor or regulatory audits (e.g., USFDA, EMA). Familiarity with electronic QMS or eTMF systems. Certification in GCP or Quality Assurance will be an added advantage.

Location : Vijayawada , Andhra Pradesh Office timings : 1:30 Pm to 10 PM Client details : Channelsoft IT services Pvt Ltd Domain: Health Care (Clinical Trails) About Channelsoft Channel Soft is a pioneer in IT outsourcing and offshore software development business that envisioned and instigated the adoption of the flexible business practices that today enable our client companies to operate more efficiently and produce more value. Currently in India we have employees around 550+ working on various technologies like java,.net , DB, BI, AWS and support team . Office address : Nagarjuna nagar , near NTR university , Vijayawada . Responsibilities For Clinical SAS Programmer: Creating and executing SAS edit check programs Validating edit check programs using standard validation practices and processes Creating, validating and executing SAS programs and macros Utilizing SAS programming skills to provide ad-hoc reports (external and internal) and participating in project meetings (internal and external) Assist in developing programming specifications and in creating program specific validation plans Identifying and implementing solutions for complex reporting needs Creating and/or reviewing data editing and export specifications Working directly with clinical data manager and where needed with clinical project manager and other team members to ensure specifications are clear and accurate. Has a clear understanding of the contextual requirements for reporting outputs; and provides feedback Programming data cleaning/consistency checking programs to support internal applications for all therapeutic areas Programming and testing data export programs in accordance with specific client needs Documenting all programming and validation efforts in accordance with Good Clinical Practices Monitoring data integrity throughout a given study and utilizing SDTM guidelines to create transfer datasets Participating in the development of data editing conventions, specification documents and Clinical Data Management (CDM) processes Contributing to, designing and maintaining a library of reusable code Leading and managing enhancements to current CDM systems and providing inputs in the implementation of new systems Working independently and efficiently with minimal input required from the manager. Reviewing timelines; and projecting estimates and target dates in conjunction with direct supervisor and project team Adhering to target dates for project timelines and communicating any changes in target date to appropriate personnel including Project Manager Keeping department head informed of progress as well as potential impediments Adhering to established processes and standards Reading, understanding and adhering to organizational Standard Operating Procedures (SOP) Assisting in establishing and enforcing departmental standards Maintain and review clinical programming SOPs and participating in the modification of company SOPs Working with internal staff to resolve issues and exploring new opportunities to add value to organization and departmental processes Helping others to achieve results and performing other duties as assigned Attending and participating in applicable company-sponsored training Education: Bachelors or Masters degree in computer science, life sciences or related field preferred SAS Certified Professional considered a plus What were looking for 3 + years SAS programming experience in pharmaceutical related industry required (1 year with Masters degree) Experience working with CDISC, SQL and Relational Databases preferred Demonstrated programming skills required Working knowledge and solid understanding of database organization and how to extract data in order to generate listings and reports Proven ability in analyzing data and understanding of medical and/or clinical trial terminology is desirable Proven ability in problem solving and ability to work in group setting and independently; ability to adjust to changing priorities Excellent attention to detail and orientation toward meticulous work Strong interpersonal and communication skills, both verbal and written Strong documentation , organizational skills and ability to project and maintain a professional and positive attitude

Business Development Manager Location Ahmedabad /Mumbai/Hyderabad Life science market research company Identify business opportunities from the existing clients and convert them into workable projects.

Investigator Payment Associate - India, Chennai - Hybrid, 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 Investigator Payment Associate to join our diverse and dynamic team. As an Investigator Payment Associate at ICON, you will play a crucial role in facilitating investigator payments, ensuring compliance with regulations, and reviewing the financial aspects of clinical trials. What you will be doing: Processing investigator payments accurately and timely according to study protocols. Maintaining documentation and records related to investigator payments in compliance with regulatory requirements. Discussing with internal teams to resolve payment discrepancies and address inquiries from investigators. Assert the development and implementation of processes to streamline investigator payment procedures. Assisting in the preparation of financial reports and analysis related to investigator payments. Your profile: Bachelor s degree in finance, Accounting, or related field. 1-2 years of experience in finance or accounting roles, preferably in the pharmaceutical or clinical research industry. KNwledge of regulatory requirements related to investigator payments (e.g., Sunshine Act, FMV). Strong attention to detail and ability to work accurately in a fast-paced environment. Proficiency in Microsoft Excel and financial software (e.g., SAP, Oracle). Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams. 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 requirementsWe 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 EmployeePlease click here to apply

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 Commitment to Diversity and Inclusion: Accessibility and accommodation 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:

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 Design, implement, and manage data integration solutions using SAP Cloud Integration for Data Services (CI-DS) Collaborate with IT and business stakeholders in reviewing business requirements for new capabilities, enhancements, system upgrade or new deployment. Assist in the implementation and configuration of basic IBP functionalities. Deliver the IT solutions following best practices and aligning People, Process, Technology & Data. Engage with IT, Supply Chain and Business Insights & Analytics (BI&A) colleagues for Develop, configure, and maintain integration flows between SAP systems and external applications Actively participate in various meetings with internal and external stakeholders in driving timely closure of project and support activities. Ensure timely resolution of outstanding tickets (bug-fixes, enhancements) as per the SLA guidelines & data accuracy, integrity, and consistency across systems. Monitor and provide system support ensuring system operates under the service level agreement around availability, performance, accuracy & reliability. Perform unit and integration tests and assist with user acceptance testing and creation of configuration and technical specification documents. Provide system training on new capabilities to the business stakeholders. Qualifications and Experience 2-4 years of experience working with SAP CI-DS as a developer, focusing on data integration and transformation projects. Basic understanding of demand, supply and S&OP business processes. Experience with developing, implementing or supporting supply chain planning solutions (esp. SAP-IBP) Bachelor s Degree in technical engineering, science field or related discipline is required. Familiarity with SAP ECC, S/4HANA, or other SAP solutions is a plus. Exposure to data integration technologies (such as HCI, CPI) with SAP-ERP and other non-SAP systems. Agile and critical thinker with a passion for innovation and learning new skills. Excellent verbal, written and interpersonal communication skills; ability to strategically collaborate and influence in the defined area of scope. Ability to easily navigate through multiple tasks and initiatives. Good planning, problem solving, analytical, time management and organizational skills Ability to work independently and collaboratively in a team environment. SAP certification in CI-DS or IBP is an advantage. 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.

Sponsor-dedicated: Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, youll be at the heart of our clients innovation. As a Principal Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program. Position Overview: This position reports to the Director, Biostatistics and Programming in the FSP Services business unit in Cytel. The Principal Statistical Programmer works independently with only concept level instruction and very little supervision, tracks progress, and provides expert technical support to team members. We are looking for a highly experienced senior statistical programmer who will work on clinical development programs on different therapeutic areas and participate in overseeing CRO programmers to ensure that data summaries are delivered in a consistent, high-quality manner. This individual will be responsible for implementing all reporting and analysis activities for the Sponsor clinical trials. Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have: At a minimum bachelor s degree in computer science, data science, mathematics, or statistics major preferred 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device development, or intervention studies Exceptional SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment Extensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities Must be able to work independently Outstanding communication skills (written and verbal) and strong leadership skills Preferred Qualifications (nice to have) Prior work experience with pharmacokinetic data and the neuroscience field, proficiency in languages or tools other than SAS (e.g., R, Python, and Java, Shiny, Markdown, Unix/Linux and git) As a Principal Statistical Programmer, your responsibilities will include: Generate SDTM, ADaM specifications, datasets, reviewer s guide and define.xml files for multiple studies Develop SAS programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs needs Participate in overseeing CRO s statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelines Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions. Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros Participate in the development of CRFs, edit check specifications, and data validation plans Provide review and/or author data transfer specifications for external vendor data Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices

Role & responsibilities Lead, mentor, and manage the Pharmacovigilance QA team to ensure effective execution of QA activities. Develop, implement, and maintain QA processes, procedures, and tools aligned with regulatory guidelines (e.g., ICH, FDA, EMA). Monitor and ensure compliance of pharmacovigilance activities with applicable regulations and internal SOPs. Conduct risk assessments and develop mitigation plans to ensure PV compliance . Oversee the management and closure of CAPAs (Corrective and Preventive Actions) following audits or inspections. Plan, coordinate, and conduct internal and external audits of PV processes, systems, and vendors audits ( Risk Based Audit approach ). Lead audit preparedness activities and ensure timely resolution of audit findings. Collaborate with cross-functional teams to implement audit recommendations and continuous improvements. Maintain audit documentation and track audit metrics for management review. Ensure all QA activities support compliance with global pharmacovigilance regulations, including GVP (Good Pharmacovigilance Practices). Participate in regulatory inspections and provide QA support as needed. Review and approve quality documentation related to PV activities such as SOPs, training materials, and audit reports. Identify QA training needs for the PV team and develop training programs accordingly. Conduct and coordinate training sessions on quality standards, SOPs, and compliance requirements. Promote a quality culture and awareness within the PV department. Identify gaps and areas for improvement within PV and QA processes and implement best practices. Collaborate with PV operations and other departments to optimize workflows and enhance quality outcomes. Utilize metrics and KPIs to monitor quality performance and drive continuous improvement. Act as the key liaison between PV, QA, regulatory affairs, and other stakeholders. Provide guidance and support on quality-related matters to internal teams and external vendors. Facilitate effective communication to ensure alignment on quality expectations and deliverables. Plan, assign, and review work for QA team members and provide ongoing feedback and development opportunities. Facilitate team meetings and promote continuous communication and knowledge sharing within the team. Support recruitment, onboarding, and performance management of QA staff. Preferred candidate profile Bachelors degree in Pharmacy, Life Sciences, or related field (Master’s preferred). Extensive experience (typically 7+ years) in Pharmacovigilance with significant exposure to QA activities. Strong knowledge of global pharmacovigilance regulations, GVP, and quality management systems. Proven leadership and team management skills. Experience in conducting audits and managing CAPAs . Excellent communication, organizational, and problem-solving skills. Ability to work collaboratively with cross-functional teams and external vendors.

Paytm is India's leading mobile payments and financial services distribution company. Pioneer of the mobile QR payments revolution in India, Paytm builds technologies that help small businesses with payments and commerce. Paytm’s mission is to serve half a billion Indians and bring them to the mainstream economy with the help of technology. About the team Oil & Gas This team is directly responsible for growth of Oil and Gas offline transactions & users at Paytm. About the role Team Leader To work with the business to understand and manage Programs being run for the Clients/Brands. And for accelerating the core growth metrics focusing on sales & distribution. Provides guidance and instruction to a working group about a project or portfolio of projects. These leaders are responsible for monitoring the efforts of the team members and getting the work done effectively and efficiently with the proper utilization of resources. Skills that will help you succeed in this role: 2+ yrs. of experience in Distribution sales in fintech, Banking/ Sales, EDC Sales. Develop plans and strategies for developing business and achieving the company's sales goals. Create a culture of success and ongoing business and goal achievement. Manage the sales teams and resources to deliver growth. Hire and build a new team to support our growing needs and future projects. Define optimal sales force structure. Define and coordinate sales training programs that enable staff to achieve their potential and support company sales objectives. Manage customer expectations and contribute to a high level of customer satisfaction. Define sales processes that drive desired sales outcomes and identify improvements. Going to the Merchant and educating him/her about the benefits of the Swipe machine (EDC) converting them and managing their accounts. Exceptional communication, presentation skills and relationship building skills. Ability to aggressively manage the successful execution of a sales strategy. Ability to work independently and collaboratively in a team environment. Qualifications: Bachelor's degree in business, marketing, or a related field (MBA preferred). Should have a strong understanding of the local language. Self-motivated and goal-oriented, with a demonstrated ability to work independently and as part of a team. Willingness to travel as needed to meet with clients and attend industry events.

Role & responsibilities Identifying/selecting an investigator who will be Responsible for The conduct of The trial at The trial site. Liaise with doctors/consultants or investigators on conducting the trial. Setting up The trial sites, which includes ensuring each centre has The trial materials, including The trial drug often known as The investigational medicinal product. Training The study staff in standard operating procedure for The clinical trials as per applicable regulatory requirements. Verify that investigator and investigators team are adequately trained and comply with The protocol. Verify that IRB/IEC operates and complies as per GCP, SOP and applicable regulatory requirements. Monitoring The trial throughout specified duration involving Monitoring visit to The trial sites. Source data verification Informed consent form review, case report form review, investigational drug accountability, and adverse event review. Ensuring all unused trial supplies are accounted for. Writing visit reports, filing and collecting trial documentation and reports. Preferred candidate profile Pre-requisites for - Sr. Project Executive / CRA / Sr. CRA: B. Pharm/ BSc / Biotech + Clinical Research Degree / Diploma / Masters Candidate must possess excellent communication skills and ability to build excellent relationships with the trial staff and colleagues. ICH-GCP knowledge is a must. Ready to travel within and out of Mumbai at various trial sites. Willing to travel 50-60%. Attention to detail Good organisational and administrative skills (knowledge of word and Excel) Perks and benefits Salient Features of this job Chance to work in a supportive and flexible environment. Directly interact with customers from the USA and Europe. Vedic Lifesciences has been rated highly by our alumni last 22 years, as a great place to work and learn

Job description : As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in 100 countries, Fortrea is transforming drug and device development for partners and patients across the globe. Perform the role of the Lead Statistical Programmer. Plan, execute and oversee all programming activities on a study, including but not limited to, resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments and the client, etc. Develop and maintain SAS programs to create complete SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs. Produce Define XML/PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides to support SDTMs and ADaMs. Develop and/or lead the development of complex specifications for SDTMs and ADaM datasets and contribute to the development of Fortrea and Client standards. Review SAPs and TFL shells from a programming perspective for studies and advise on the development of complex TFL shells from a programming perspective. Mentor less-experience programmers in the processes around SDTMs, ADaMs and TFLs ensuring adherence to department practices and processes. Present and share knowledge at department meetings. Respond to QA and client audits and support qualification audits. Contribute to proposal activities and participate in bid defenses meetings in order to win new business. Continually identify and suggest ways to improve the efficiency, quality and productivity of statistical programming. And all other duties as needed or assigned.

Hi We are hiring for Leading ITES Company for Clinical Data Manager Profile. Role & responsibilities: Candidate should have 2-5 years of experience of CDM with experience in Conduct Scope of work Perform day-to-day Clinical Data Management activities. Experience in doing external data reconciliation Work and coordinate with the team to perform data management activities and deliver an error-free quality database in accordance with the data management plan and regulator standards. Read and understand the study protocol and the timelines. Perform test data entry in the TEST environment, data listing review, data reconciliation, and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate. Perform external checks to handle manual discrepancies and action the same. Ensure an error-free, quality data with no open queries. Escalate any discrepancy in the clinical data to the study lead as appropriate. Timely completion of training Any other tasks deemed appropriate To perform medical data collection and analysis of Prostate Cancer Data using databases like HIS/ EMR (Electronic Medical Record) and Caisis, Rave, CDM (startup, closeout, conduct) Client interaction and meetings. Bringing up new ideas and executing new plans to cope with the backlog. Training new team members as and when required. To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 205 b) To Apply for above Job Role ( Pune ) Type : Job Code # 206 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 207

SUMMARY Job Title: SAR & SAR-like Patient Safety Physician Reporting To: Patient Safety Physician SAR & SAR-like Coordinator Minimum Educational Qualifications and Experience Required Skills Proficient in delivering presentations Effective at collaborating across different cultures Strong preference for structured and process-driven tasks Committed to completing training and documentation on time Operational Responsibilities Compile PBRERs with a focus on medical aspects and safety sections of products, and analyze safety trends, including source data analysis based on queries Assist in identifying, analyzing, and drawing conclusions from safety data for cumulative trends Collaborate with Therapeutic Head to identify signals and address product safety concerns Engage with Therapeutic Area colleagues for enhanced understanding and development Measurable Goals Ensure 100% compliance with timely completion of all client and Cognizant required trainings Achieve 100% compliance with work allocation plan, including case closure based on agreed timelines and quality benchmarks Non - Measurable Attributes Self - motivated Goal-oriented Interdepartmental collaboration Personal grooming and etiquette Punctuality Team player and process-oriented Requirements Requirements: Relevant educational background and experience in patient safety or related field Strong presentation and communication skills Effective intercultural work capabilities Commitment to timely completion of tasks and documentation Analytical and problem-solving skills Collaboration and teamwork abilities

Design statistical analysis plans for clinical trialsobservational studiesand laboratory experiments. Perform statistical analyses using appropriate software (egSASRPython). 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 (egFDAEMA). 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.