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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