What are the responsibilities and job description for the Principal Clinical Data Manager position at cGxPServe?
Responsibilities :
- Lead data management activities, ensuring accuracy, consistency, and compliance with regulatory standards.
- Oversee database build activities, data collection, coding, cleaning, and database lock.
- Develop and execute data management plans, including risk management strategies.
- Work closely with internal and external stakeholders, including Biostatistics, Clinical Development, Quality Assurance, and Regulatory Affairs, to facilitate seamless data flow and compliance.
- Serve as the primary data management contact for assigned therapeutic areas, ensuring proper planning and issue resolution.
- Ensure timely and quality deliverables within project timelines and budget constraints.
- Develop and implement validation checks, conduct data reviews, and resolve data discrepancies to maintain high data standards.
- Ensure compliance with Good Clinical Practice (GCP), ICH guidelines, FDA regulations, and CDISC standards.
- Supervise database development, validation, and transfer processes in accordance with SOPs and regulatory requirements.
- Provide subject matter expertise in clinical data management systems, electronic data capture (EDC) platforms, and data standards such as CDISC.
- Develop and manage electronic Case Report Forms (eCRFs), data transfer specifications, and validation reports.
- Establish and refine data management standard operating procedures (SOPs) and best practices.
- Mentor and train junior data managers, fostering a collaborative environment and continuous learning culture.
- Ensure direct reports have adequate training and skills to meet regulatory and company standards.
- Guide teams on clinical data management best practices and evolving industry requirements.
- Maintain GCP inspection readiness by ensuring proper documentation and compliance with regulatory requirements.
- Serve as the primary point of contact for data management activities during audits and inspections.
- Review and approve key project documents, including Data Management Manuals, CRF Completion Guidelines, and validation specifications.
Requirements :
