Senior Data Manager, CRO Oversight, Early Phase Studies

Description:
Remote

Our client is seeking a Senior Data Manager to provide operational support across multiple early-stage clinical studies in a wide variety of therapeutic areas. This individual will partner with cross-functional study teams and external CROs to ensure the timely delivery of high-quality clinical data that supports informed decision-making throughout Phase 1 first-in-human and Phase 1b/2 patient studies. This is a highly operational role requiring the ability to manage multiple programs simultaneously and serve as a trusted partner to study teams, while maintaining flexibility in a fast-paced, resource-efficient environment. This individual will report into our client's Associate Director of Data Management & Technology.

Due to client requirements, applicants must be willing and able to work on a w2 basis. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance.

Rate: $80.00 to $90.00/hr. w2

Responsibilities:

• Review and contribute to study-specific data management plans, edit check specifications, data review plans, CRF/eCRF design, database specifications, and data transfer agreements.
• Participate in protocol review to ensure data collection strategies support study objectives while minimizing operational complexity.
• Serve as sponsor-side oversight of CRO and specialty vendor data management deliverables, including scope and specifications, timelines, quality, metrics review, and issue escalation, while retaining accountability for partner-executed work.
• Own database build oversight, user acceptance testing (UAT), database lock activities, and study closeout.
• Drive ongoing data review, query management, reconciliation activities including safety, laboratory, and external vendor data, and issue resolution throughout study conduct.
• Deliver clean, near-real-time data on compressed timelines to support dose-escalation decisions, safety review committee meetings, DLT assessment, and interim data cutoffs.
• Monitor data quality metrics and proactively identify risks that may impact study timelines, database quality, or regulatory readiness.
• Support the preparation for interim analyses, regulatory submissions, and clinical study reports by ensuring timely, high-quality datasets.
• Serve as the Medidata user administrator at the URL level, including assigning access to CRO study builders, coders, and data managers at the CRO.
• Evaluate and recommend improvements to clinical data management systems, technologies, and workflows as appropriate.
• Contribute to inspection readiness activities and ensure compliance with applicable Google Cloud Platform, ICH, FDA, EMA, and other regulatory requirements.

Experience Requirements:

• Bachelor's degree in Life Sciences, Computer Science, Biostatistics, Data Science, or related field.
• 8-12 years of data management experience, with the majority on the sponsor side.
• Minimum 3+ years leading Phase 1 studies, including first-in-human healthy volunteer SAD/MAD and Phase 1b/2 patient studies as Lead Data Manager.
• Sponsor-side oversight of CRO and specialty vendor data management, including specification review, deliverable and timeline oversight, and escalation of underperformance.
• Hands-on Medidata Rave experience, including study configuration, edit check specification, and Rave reporting. Working knowledge of other EDC platforms such as Veeva or Oracle InForm is a plus.
• Familiarity with CDISC standards (SDTM), data reconciliation processes, coding dictionaries, and database lock activities.
• Solid understanding of ICH-Google Cloud Platform, FDA, EMA, and other applicable clinical data management regulations and guidance.
• Excellent analytical, organizational, and communication skills with strong attention to detail and the ability to collaborate across cross-functional scientific and operational teams.
• Nice to have: Experience working alongside a Biometrics vendor responsible for biostatistical activities.

Education Requirements:
Bachelor's degree in Life Sciences, Computer Science, Biostatistics, Data Science, or related field.

Recruitment Transparency Notice



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Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range.

W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality.
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About Eliassen Group:

Eliassen Group is a strategic consulting firm that helps organizations reach further and achieve more through our technology, business advisory, and life sciences solutions. For nearly 40 years, we have combined exceptional people, deep domain expertise, and intelligent capabilities to expand our clients' capacity and accelerate meaningful outcomes. We are driven by a purpose to positively impact the lives of our employees, clients, consultants, and the communities we serve.

Eliassen is committed to building a diverse and inclusive team from a variety of backgrounds, perspectives, and skills. We are an Equal Opportunity and Affirmative Action Employer and all employment decisions are based on merit, performance, and business needs. Eliassen does not discriminate on the basis of race, color, gender identity or expression, sexual preference or orientation, sex (including pregnancy, childbirth, and related medical conditions), marital status, creed, religion, physical or mental disability, genetic information, military or veteran status, age, ancestry, national origin, citizenship status, prohibited criminal record inquiries of applicants and employees, or any other category protected by federal, state, or local laws.

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