Senior Clinical Data Manager

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

📋 Description

• Oversee and coordinate several clinical studies, ensuring that data is collected, managed, and communicated clearly, accurately, and securely.

• Execute tasks in alignment with regulatory standards, industry guidelines, and company SOPs while fulfilling sponsor requirements and timelines.

• Act as the data management point of contact for project teams, sponsors, and external vendors.

• Independently oversee three to four simultaneous studies with little supervision and make decisions with limited managerial support.

• Participate in sponsor meetings and address data management inquiries.

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

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

• Program or assist with programming and sustain clinical databases.

• Validate and test clinical databases, which includes User Acceptance Testing.

• Generate eCRF completion guidelines and training materials; conduct training for site users and monitors.

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

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

• Aid in the development of external clinical data systems such as ePRO and IWRS, including documentation and testing of data transfers.

• Create data management plans and associated documentation.

• Conduct ongoing data review and cleaning throughout the study and during database lock/close phases.

• Code medical terms in clinical databases as needed.

• Produce data listings and reports for data review and database closure/lock.

• Track study progress and provide data status updates to project teams.

• Maintain comprehensive and up-to-date data management documentation in the trial master file.

• Assist EDC system users requiring support.

• Archive clinical databases and related documents.

• Contribute to defining, drafting, and updating data management Work Instructions.

• Mentor and train Clinical Data Coordinators and assist less experienced Clinical Data Managers.

• Supervise outsourced activities and vendors to ensure adherence to timelines, deliverables, work orders, sponsor requirements, protocol specifications, and SOPs.

• Assume other relevant responsibilities as assigned.

⛳️ Requirements

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

• 5 to 8 years of experience in clinical data management within the clinical research sector, specifically in biotechnology, pharmaceuticals, or contract research organizations (CRO).

• Familiarity with the drug development process and relevant regulations, including Good Clinical Practices and ICH Guidelines.

• Significant experience utilizing EDC systems and/or database structures.

• Proven skills in database programming are advantageous.

• Strong understanding of CDISC SDTM/CDASH standards.

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

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

• Proficient in MS Excel.

• Knowledge of SAS or similar tools is an added benefit.

• Exceptional problem-solving skills.

• Capability to thrive in a fast-paced environment while managing and prioritizing multiple competing demands.

• Familiarity with MedDRA and WHODrug dictionaries.

• Must possess legal authorization to work in Argentina.

• Availability to attend some meetings outside regular business hours, primarily in the evening.

🏝️ Benefits

• Flexible work schedule.

• Permanent full-time position.

• Continuous learning and development opportunities.

• Engaging work environment.

• Attractive opportunities for advancement.