Lead Clinical Data Manager

About the Role

Medtek Dot Ai is looking for a seasoned and meticulous Lead Clinical Data Manager to take ownership of data management work for clinical studies run for pharmaceutical and biotech clients. The role focuses on ensuring that clinical data is captured, cleaned, processed, and delivered accurately, on time, and in line with regulatory expectations.

Medtek is a data science–driven company that helps accelerate drug development and healthcare outcomes. The company supports growing biotech and pharma organizations with data technology, data analysis, data mining, CDISC, visualization, and regulatory reporting.

Key Responsibilities

• Own and drive the full clinical data management lifecycle for assigned studies.
• Create, review, and maintain data management plans, CRFs/eCRFs, edit check logic, and database specifications.
• Work closely with Biostatistics, Clinical Operations, Medical Writing, and Regulatory Affairs teams.
• Manage database build, testing, and validation activities in EDC platforms such as Medidata Rave.
• Carry out continuous data review, manage discrepancies, and handle query creation and closure.
• Make sure database lock, database freeze, and related quality outputs are completed within project timelines.
• Track adherence to ICH-GCP, CDISC, FDA, EMA, and other applicable regulatory requirements.
• Serve as the main client contact for all data management-related matters.
• Perform reconciliation of safety and efficacy data.

Qualifications and Experience

The position calls for a candidate with strong clinical data management expertise and a solid understanding of clinical trial workflows, data standards, and regulatory compliance.

Preferred Background

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Health Informatics, or a related discipline.
• At least 9 years of experience in clinical data management within a CRO, pharmaceutical, or biotech setting.
• Hands-on experience with EDC systems such as Medidata Rave or Oracle InForm.
• Strong command of clinical trial processes and Good Clinical Practice.
• Working knowledge of CDISC standards, including SDTM, along with MedDRA and WHO Drug dictionaries.
• Excellent accuracy, analytical thinking, and problem-solving ability.
• Strong written and verbal communication, planning, organization, and project coordination skills.
• Comfort working independently while also thriving in a fast-moving team environment.

Additional Qualifications

• Exposure to oncology, rare disease, or other complex therapeutic areas is preferred.
• Familiarity with SAS or SQL would be an added advantage.
• A clinical data management certification such as CCDM from SCDM is considered a plus.

What’s on Offer

• The chance to contribute to advanced clinical research programs.
• A collaborative workplace that is flexible and supportive of professional growth.

Compensation

Annual compensation is listed as INR 17,00,000 to INR 25,00,000.