Senior Data Manager, CRO Oversight, Early Phase Studies
Anywhere
Category: Clinical Ops
Industry: Life Sciences
Workplace Type: Remote
Reference ID: JN -072026-108144
Date Posted: 07/30/2026
Shortcut: http://careers.eliassen.com/CzFCkb
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 GCP, 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-GCP, 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.
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.
If anyone reaches out to you about an open position connected with Eliassen Group, please ensure that you are working directly with us by confirming the following:
· When you work with Eliassen Group, all email communication will come from an Eliassen.com address, never Gmail, Yahoo, etc.
· Eliassen Group will never ask you for personal information (home address, bank account, or check routing number) until you have worked with someone clearly associated with Eliassen Group.
If you have any indication of fraudulent activity, please contact fraud@eliassen.com.
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Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. Eliassen Group’s Affirmative Action Plan (AAP) is available for inspection by any employee or applicant for employment upon request, during normal business hours of Monday through Friday, 8:30am to 5:30pm EST. Interested persons should contact Phaedra Wells at pwells@eliassen.com for assistance. It is unlawful in Massachusetts and Maryland to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Applicants with disabilities that believe they require an accommodation or assistance with a position, please email our HR team at hradmin@eliassen.com. This email inbox is designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Emails sent for other purposes will not receive a response.
Please be advised that a number of fraudulent job postings have been released under the Eliassen Group brand.
Unfortunately, fraudulent job postings can happen. If anyone reaches out to you about an open position connected with Eliassen Group, never provide personal or financial information to anyone who is not clearly associated with Eliassen Group
If anyone seemingly from Eliassen Group has ever requested this personal information in the past or does so in the future, please contact fraud@eliassen.com.
Please ensure that you are working directly with us by confirming the following:
- When you work with Eliassen Group, all email communication will come from an Eliassen.com address, never Gmail, Yahoo, etc.
- Eliassen Group will never ask you for personal information (home address, bank account, or check routing number) until you have worked with someone clearly associated with Eliassen Group, as indicated above