Senior Clinical Data Manager
On-siteMalvern, Pennsylvania, United States
Job Summary
Oversee clinical data management efforts including database design, CRF development, and validation for both clinical development programs and marketed products. Lead inspection readiness, ensure documentation completeness, and serve as a subject matter expert during audits while guiding the team in applying GCP, ICH, CDISC, and internal compliance standards. Mentor junior staff, manage vendors, and develop data management plans to streamline workflows and mitigate risks proactively. Partner with Biometrics, Clinical, and Regulatory teams to implement research protocols and ensure seamless data flow from collection to final analysis. Requires 5-7 years of experience in biopharma or CRO environments with strong knowledge of regulatory requirements.
Required Qualifications
- BS degree in clinical, biological or mathematical sciences, or related field, or nursing qualification, or work- related equivalent
- 5-7 years of clinical data management experience in biopharma or CRO environment
- Experience with clinical trials
- Experience with CRFs, and in the development process of EDC databases, IRT systems and diary applications for data collection
- Strong knowledge of GCPs, ICH, FDA, and CDISC regulatory requirements governing clinical studies
- Demonstrated attention to detail and outstanding organization skills
- Self-motivated with a commitment to high quality, on-time deliverables
- Excellent communication and collaboration skills with a team-oriented approach
- Demonstrated ability to identify and resolve issues and effectively manage timelines
- Able to work in a fast-paced environment
- Must be available outside of these hours to handle priority business needs
Desired Qualifications
- Veeva experience is preferred
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