Remote Clinical Data Management Job Openings at Red Nucleus, Apply on Biotecnika
Associate / Senior Associate
Clinical Data Management
Reports to: Director/ Senior Director, Clinical Operations
Business Unit: SS&A
Department: Clinical Research
Location: Remote
Experience: 3+ years
Salary Range: ₹20 LPA – ₹25 LPA
Job Overview
The Associate / Senior Associate, Clinical Data Management is responsible for delivering and overseeing clinical and patient-reported data within electronic data capture (EDC) platforms, including iTakeControl. The role involves monitoring databases, ensuring data quality and integrity, and supporting research studies from conception to closeout. This position collaborates closely with Clinical Operations, Product Management, and Technical Delivery teams, providing specifications, documentation, and support for clinical operations, project management, and client projects.
Responsibilities
• Act as primary contact for stakeholders, lead calls, and manage interactions with supervision.
• Manage timelines, milestones, and ensure adherence to deadlines.
• Provide data management support across projects, sponsors, sites, and vendors.
• Ensure data integrity and compliance with GxP processes.
• Understand study requirements, EDC/EHR systems, user needs, and business logic.
• Work with ePRO systems for patient-centric research and engagement.
• Conduct clinical/ePRO data review (including video), query generation, and reconciliation.
• Manage data transfers, exports, extractions, and migrations as per client requirements.
• Develop Data Management Plans, CRF specifications, eCRFs, and related documentation.
• Prepare and manage training content, caregiver/site manuals, and conduct SIV/training sessions.
• Support UAT, product launches, audits, and quality control testing.
• Collaborate with cross-functional teams including biotech clients and developers.
• Explore options for remote monitoring of research site source data.
• Assist in literature searches, audit responses, and adoption of new technologies.
• Ensure compliance with SOPs, quality, and regulatory requirements.
Education, Experience, Training, and Knowledge
Education: Undergraduate degree from an accredited university.
Experience:
• Minimum 3+ years in clinical data management.
• Experience with clinical study protocols, amendments, registries, and observational research.
• Proficiency in data migrations, transfers, and reporting.
• Knowledge of FDA 21 CFR Part 11, Annex 11, HIPAA, GDPR, and compliance standards.
• Professional experience in biopharma, CRO, clinical study sites, or consulting.
• Understanding of registries and drug development (Phase 1–3).
• Project management experience managing multiple studies simultaneously.
Skills & Abilities:
• Strong proficiency in Microsoft Office and awareness of EDC/ePRO/EHR systems.
• Excellent communication, problem-solving, and project reporting skills.
• Ability to work independently and collaboratively in teams.
• Knowledge of clinical and health data standards (CDISC, CDASH, SDTM, FHIR, OMOP).
• Familiarity with MedDRA and WHO Drug coding.
• Ethical, detail-oriented, and passionate about innovation.
Preferred Qualifications
• Experience with digital/mobile health applications.
• Exposure to rare diseases, gene therapy, or long-term follow-up studies.
• Prior work with central/specialty labs or vendors.
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