Senior Clinical Data Manager

This is a fully remote position, open to applicants in India.

📋 Description

• Oversee and coordinate various clinical studies, ensuring that data collection, management, and reporting are conducted clearly, accurately, and securely.

• Ensure that all activities adhere to regulatory standards, industry best practices, company SOPs, sponsor requirements, and project timelines.

• Act as the data management liaison for project teams, sponsors, and external vendors.

• Independently handle three to four simultaneous studies with minimal oversight.

• Participate in sponsor meetings, addressing inquiries related to data management.

• Contribute to timeline planning and monitor the scope of work for timely and budget-compliant project completion.

• Create eCRF specifications, including data capture screens and edit checks, tailored for study-specific clinical databases and EDC systems.

• Program, maintain, validate, and test clinical databases, encompassing User Acceptance Testing.

• Develop eCRF completion guidelines and training resources; provide training to site users and monitors.

• Establish data transfer agreements and specifications with external data vendors.

• Reconcile external data with EDC data and sponsor safety databases as necessary.

• Assist in the development and integration of external clinical data systems like ePRO and IWRS.

• Formulate data management plans and associated documentation.

• Conduct ongoing data review and cleaning up to the database lock/close phase.

• Code medical terminologies in clinical databases as needed.

• Produce data listings, reports, and data status updates for study teams.

• Monitor study progress, including enrollment and CRF monitoring/approval processes.

• Ensure that all data management documentation in the TMF is complete and current.

• Address EDC user assistance requests promptly.

• Archive clinical databases and related documents appropriately.

• Define, draft, and revise data management Work Instructions.

• Mentor and train Clinical Data Coordinators while supporting less experienced Clinical Data Managers.

• Supervise outsourced data management vendors to ensure their deliverables align with sponsor, protocol, work order, and SOP requirements.

⛳️ Requirements

• Bachelor’s degree in a relevant field of study.

• 5 to 8 years of experience in clinical data management within the biotechnology, pharmaceutical, or CRO sectors.

• Comprehensive understanding of the drug development process and relevant regulations, including Good Clinical Practices and ICH Guidelines.

• Extensive experience with EDC systems and/or database structures.

• Proven database programming skills are advantageous.

• Solid understanding of CDISC SDTM/CDASH standards.

• Highly organized and detail-oriented, with strong project planning and time management abilities.

• Excellent verbal and written communication skills in English; proficiency in French is a plus.

• Strong knowledge of MS Excel.

• Familiarity with SAS or similar tools is an asset.

• Exceptional problem-solving skills.

• Ability to thrive in a fast-paced environment and effectively prioritize multiple competing tasks.

• Understanding of MedDRA and WHODrug dictionaries.

• Must have legal authorization to work in India.

🏝️ Benefits

• Flexible work schedule.

• Permanent full-time employment.

• Continuous learning and development opportunities.

• Home-based work arrangement.