Manager, Clinical Data Management
New
O
OraClinical research
Remote - USFull-TimeManager
Salary not disclosed
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Job Details
- Experience
- At least five (5) years of experience in Clinical Data Management including leading several clinical studies with a master’s degree; or a minimum of six (6) years of experience in clinical trials with a bachelor’s degree or equivalent education and work experience; or current Certified Clinical Data Manager (CCDM) status and six (6) years of experience in clinical trial. Two (2) years of experience direct management of personnel is required.
- Required Skills
- Project ManagementPeople Management
Requirements
- Hold a master’s degree, preferably in Engineering, Applied Science, or Life Science, and have at least five years of Clinical Data Management experience, including leading several clinical studies; or hold a bachelor’s degree or equivalent education and work experience with at least six years of clinical-trial experience; or hold current Certified Clinical Data Manager (CCDM) status and have six years of clinical-trial experience.
- Have at least two years of direct personnel management experience.
- Bring extensive clinical research experience.
- Have expert knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations.
- Demonstrate project management abilities, including analytical evaluation, organization, delegation, team management, negotiation, and resource management.
- Have leadership, budget forecasting, and implementation skills.
- CRO clinical research experience is preferred.
- CDISC SDTM training is preferred.
- Experience with multiple EDC systems, including Medidata Rave, is preferred.
- Be available to travel up to 10% if required.
Responsibilities
- Manage assigned clinical studies to ensure quality, timely delivery, and adherence to study budgets.
- Manage allocated staff, including mentoring, training, and conducting performance reviews.
- Serve as a subject matter expert in client and vendor meetings.
- Support business development through capabilities presentations to prospective and current clients.
- Provide input for department and clinical study budgets.
- Coordinate with internal and external cross-functional teams, sponsors, and vendors.
- Plan project work and allocate resources to support successful execution.
- Develop or update Standard Operating Procedures, Work Instructions, Forms, and Templates.
- Monitor team performance and partner with Data Management leadership on process and resource improvements.
- Maintain compliance with quality systems, data integrity, business ethics, and regulatory requirements.
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