Principal Clinical Data Manager
Principal Clinical Data Manager
Posted on :
08-03-2025
Employer Active
1 Vacancy
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Job Description
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:
- Bachelors degree in clinical biological or mathematical sciences nursing or a related field.
- Minimum of 6 years of clinical data management experience in pharmaceutical development or CRO environment.
- Extensive experience with clinical trials EDC databases IRT systems and diary applications for data collection.
- Strong knowledge of GCP ICH FDA and CDISC regulatory requirements governing clinical studies.
- Proven ability to develop SOPs risk management strategies and data management plans.
- Demonstrated leadership problemsolving and project management skills.
- Excellent organizational communication and collaboration skills with a teamoriented approach.
- Selfmotivated with a commitment to highquality ontime deliverables.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract
Employment Type
Contract
Key Skills
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