Lead Clinical Data Manager
Lead Clinical Data Manager
Posted on :
20-09-2025
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1 Vacancy
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Job Description
Job Description:
We are seeking a highly skilled Lead Clinical Data Manager to join our team on a contract basis. The ideal candidate will have extensive experience in Clinical Data Management (CDM) within the Medical Device or Pharmaceutical industry with deep expertise in Medidata Rave. Therapeutic area knowledge in Cardiovascular Neurovascular or General Surgery is required.
Responsibilities:
We are seeking a highly skilled Lead Clinical Data Manager to join our team on a contract basis. The ideal candidate will have extensive experience in Clinical Data Management (CDM) within the Medical Device or Pharmaceutical industry with deep expertise in Medidata Rave. Therapeutic area knowledge in Cardiovascular Neurovascular or General Surgery is required.
Responsibilities:
- Lead end-to-end data management activities for clinical trials across assigned studies.
- Oversee data collection cleaning validation and database lock activities.
- Develop and review CRFs edit checks and data validation plans in Medidata Rave.
- Collaborate with cross-functional teams (Clinical Operations Biostatistics Medical Writing).
- Ensure compliance with GCP ICH guidelines and regulatory requirements.
- Manage timelines deliverables and vendor oversight for data management.
- Mentor junior data management staff and provide technical guidance.
- Bachelors degree in Life Sciences or related field (masters preferred).
- 6 years of Clinical Data Management experience in Medical Device or Pharmaceuticals.
- Strong hands-on expertise with Medidata Rave (design build and validation).
- Therapeutic area expertise in Cardiovascular Neurovascular or General Surgery.
- Experience leading studies from start-up to database lock.
- In-depth knowledge of CDISC standards and regulatory requirements.
- Excellent communication leadership and problem-solving skills.
Employment Type
Full-time
Key Skills
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