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:

• 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.

Requirements:

• Bachelor's degree in Life Sciences or related field (master's 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.

Job Tags

Contract work,

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