Job Description

Job Description

Job Description

Job Summary:
We are seeking an experienced Lead Clinical Data Manager to oversee and manage all aspects of clinical data management activities for multiple clinical studies. The ideal candidate will ensure the accuracy, integrity, and quality of clinical trial data while collaborating with cross-functional teams, including biostatistics, clinical operations, and regulatory affairs.
Responsibilities:

• Lead and manage end-to-end clinical data management activities for assigned clinical studies.
• Develop and maintain Data Management Plans (DMP), CRF design, and edit check specifications.
• Oversee the database design, validation, and UAT testing to ensure compliance with study requirements.
• Coordinate with CROs, vendors, and internal teams to ensure timely and high-quality data deliverables.
• Perform data cleaning, query resolution, and reconciliation with clinical, safety, and laboratory teams.
• Ensure compliance with CDISC/CDASH, GCP, ICH, and regulatory guidelines.
• Participate in study start-up, interim monitoring, and database lock activities.
• Train and mentor junior data managers and team members.
• Contribute to process improvement initiatives in clinical data management.

• Bachelor's or Master's degree in Life Sciences, Pharmacy, Computer Science, or a related field.
• 5+ years of experience in clinical data management, with at least 2 years in a leadership role.
• Experience in oncology required.
• Strong knowledge of clinical trial processes, regulatory requirements.
• Hands-on experience with EDC systems (e.g., Medidata Rave, Oracle InForm, Veeva Vault, etc.).
• Excellent communication, problem-solving, and leadership skills.

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