Remote Clinical Data Manager (Manager to AD level)
Posted 1 week ago by 1753580000
Negotiable
Undetermined
Remote
San Diego, California
Summary: In this individual contributor role, the Remote Clinical Data Manager will oversee study-level data management, including CRO and vendor management, ensuring high-quality data for regulatory submissions. The position requires expertise in Veeva Vault eTMF and a proven track record in clinical data management, particularly in global Phase 3 trials. The candidate will not manage direct reports but will play a critical role in maintaining data integrity and compliance. Strong communication and project management skills are essential for success in this fast-paced environment.
Key Responsibilities:
- Oversee study-level data management and CRO/vendor management.
- Ensure high-quality, inspection-ready data for regulatory submissions.
- Utilize Veeva Vault eTMF for clinical trial data management.
- Monitor performance, resolve issues, and ensure quality assurance with CROs.
- Maintain compliance with GCP, ICH guidelines, and CDISC standards.
- Collaborate effectively with team members and stakeholders.
- Manage projects and timelines efficiently in a virtual environment.
- Contribute consistently across full trial lifecycles.
Key Skills:
- Bachelor’s degree in life sciences or related field; advanced degree preferred.
- 8+ years of clinical data management experience in pharmaceutical, biotech, or CRO environments.
- Proven CRO oversight experience with a focus on performance monitoring and quality assurance.
- Experience with Veeva Vault eTMF in clinical trials.
- Strong understanding of GCP, ICH guidelines, and CDISC standards.
- Excellent written and verbal communication skills.
- Detail-oriented with strong project and time management skills.
- Ability to work independently in a fast-paced, virtual environment.
- History of job stability in prior roles.
Salary (Rate): £72,000 yearly
City: San Diego
Country: United States
Working Arrangements: remote
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
In this individual contributor position, you will not manage direct reports but will be responsible for study-level data management oversight, including CRO and vendor management. You will play a key role in ensuring high-quality, inspection-ready data for regulatory submissions. Expertise in Veeva Vault eTMF and a solid track record of job stability in similar roles is required.
Qualifications:
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Bachelor’s degree in a life sciences or related field; advanced degree preferred.
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8+ years of clinical data management experience in the pharmaceutical, biotech, or CRO environment, with extensive experience managing global Phase 3 trials.
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Proven CRO oversight experience with a focus on performance monitoring, issue resolution, and quality assurance.
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Demonstrated experience with Veeva Vault eTMF in a clinical trial setting.
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Strong understanding of GCP, ICH guidelines, CDISC standards (CDASH, SDTM), and global regulatory requirements.
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Excellent written and verbal communication, interpersonal, and collaboration skills.
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Detail-oriented with strong project and time management skills.
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Ability to work independently in a fast-paced, virtual environment.
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History of job stability in prior roles, with consistent contributions across full trial lifecycles.
Preferred Qualifications:
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Experience supporting NDA/BLA submissions.
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Knowledge of major EDC systems (e.g., Medidata Rave, Oracle InForm).
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Background working in a small to mid-sized biotech or sponsor-side environment.
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Exposure to adaptive trial designs and decentralized trial models.
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