Job Title: Associate / Senior Associate, Clinical Data Management
Department: Scientific Services – India
Location: Remote (India)
Job Overview
The Associate/Senior Associate in Clinical Data Management is responsible for delivering and overseeing clinical and patient-reported data within electronic data capture (EDC) platforms, including iTakeControl (iTC). The role ensures database integrity, maintains data quality, and supports clinical operations from study conception to closeout. Close collaboration with Clinical Operations, Product Management, and Technical Delivery teams is essential.
Key Responsibilities
Serve as a point of contact for internal and external stakeholders, maintaining daily communication and leading calls under supervision.
Manage data management timelines, milestones, and deadlines with supervision.
Support project, sponsor, site, and vendor management under guidance.
Understand real-world protocols, data collection processes, and GxP compliance.
Maintain data integrity and adhere to study requirements and EDC/EHR systems.
Understand ePRO systems for patient-centric research and engagement under guidance.
Perform clinical and/or ePRO data review, query generation, and data reconciliation under supervision.
Manage data transfer, export, and migration processes as needed.
Develop and maintain documentation, including:
Data Management Plans (DMP)
CRF Specifications and eCRFs
Training content, caregiver/site manuals
Participate in Site Initiation Visits (SIV) and site/central rater training.
Support User Acceptance Testing (UAT) and product launch requirements.
Ensure adherence to quality, SOPs, regulatory, and compliance standards.
Prioritize project schedules and report progress effectively.
Collaborate with clients, cross-functional teams, technical developers, and biotech stakeholders.
Explore remote data monitoring options for research site source data.
Conduct literature searches to support requests from the team or clients.
Assist with quality control testing.
Support external audits and audit response efforts.
Support and mentor team members.
Demonstrate willingness to learn new technologies, including iOS and Android applications.
Education
Undergraduate degree from an accredited university.
Experience
Experience with data management per clinical study protocols, amendments, observational research, and registries.
Experience with data migration, reporting, and transfers.
Experience with health data collection and compliance standards (FDA 21 CFR Part 11, Annex 11, privacy policies).
Professional experience in biopharma, pharmaceutical industry, CROs, clinical study sites, or consulting.
Knowledge of GCP, ICH, HIPAA, GDPR, and FDA requirements for human subject research.
Knowledge of registries and/or clinical drug development pathways (Phase 1–3 studies).
Project management experience, managing multiple projects/studies with varied scope.
Skills & Abilities
Proficient in Microsoft Office (Word, Excel, PowerPoint) and aware of project management, technology management, and research systems (EDC, ePRO, EHR).
Strong verbal and written communication skills; able to escalate and negotiate solutions.
Proactive problem solver, flexible, creative, and innovative.
Collaborative in a team environment; confident working independently or under supervision.
Highly ethical and detail-oriented.
Comfortable learning new technologies, applications, and systems.
Knowledge of clinical and health data standards (CDISC/CDASH/SDTM/FHIR/OMOP).
Familiarity with medical terminology and coding dictionaries (MedDRA, WHO Drug).
Ability to provide a relevant portfolio/history of projects, studies, or applications.
Preferred Qualifications / Experience
0–10 years professional experience.
Experience with digital or mobile apps.
Experience in rare diseases, gene therapy, and long-term follow-up studies.
Previous experience working with central or specialty labs/vendors.
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