Lead Clinical Data Manager
Lead Clinical Data Manager
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Job Description
Job Description:
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.
Requirements:
- Bachelors or masters 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 and
- Hands-on experience with EDC systems (e.g. Medidata Rave Oracle Inform Veeva Vault etc.).
- Excellent communication problem-solving and leadership skills.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract
Employment Type
Contract
