Sr. Mngr or A.D., Clinical Data Manager

Eliassen Group; United States; Remote; Confidential; Full time

Benefits offered by this job

Medical, dental, vision benefits

401k with company matching

Life insurance

Job summary

Eliassen Group is seeking a Senior or Associate Director level Clinical Data Manager for a 1-year extendable engagement in the cardiovascular space. The role involves leading data management for an assigned trial, including CRF/eCRF design, EDC development, data validation, and regulatory deliverables, with remote or hybrid options in Princeton, NJ or San Francisco, CA.

Ideal candidates have 5+ years of CDM experience, CRO oversight on Phase III, and a biotech/pharma background, with a degree

Qualifications

• 5+ years in clinical data management at a manager level
• Sponsor-side CRO oversight experience for Phase III studies
• Biotech or pharmaceutical industry background
• Cardiovascular experience preferred
• Degree preferred and able to work remote (proximity to Princeton, NJ or San Francisco, CA)

Responsibilities

• Lead end-to-end clinical data management for assigned cardiovascular clinical trial in accordance with SOPs, GCP, and ICH Guidelines.
• Review study protocol and develop or review database definition files.
• Oversee creation of CRFs/eCRFs, Data Validation Plans, and Edit Check Specifications.
• Perform or oversee UAT of eCRFs and edit checks for databases in development.
• Manage change requests after database go-live.
• Review CRF/eCRF for outsourced trials and generate queries as needed.
• Review edit check specifications, Data Management Plans, and Manual Review Guidelines for outsourced trials.
• Oversee Data Transfer Agreements with ancillary vendors.
• Ensure query resolution for outsourced trials and perform SAE reconciliation.
• Review data listings and manage cross-functional data reviews to identify safety signals and support regulatory reporting, including DSUR and SUSAR.
• Provide Data Management summary reports and ad hoc reports to management and Clinical Operations.
• Ensure database close and lock at trial end.
• Resolve complex data issues to support interim analyses and timely decision-making.

Job description

Description:

Remote

Our client, a small clinical-stage biotech focused on cardiovascular medicines, seeks a Senior Manager or Associate Director level Clinical Data Manager for a 1-year extendable engagement. The role will lead data management activities for an assigned cardiovascular clinical trial, including CRF/eCRF design, EDC database development, external data processing, medical coding oversight, data review, and database close/lock in alignment with SOPs, GCP, and ICH Guidelines. The position will ensure timelines and quality across data management deliverables and collaborate with clinical operations and cross‑functional stakeholders. The engagement may be remote or hybrid in Princeton, NJ or San Francisco, CA.

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: $65.00 to $70.00/hr. w2

Responsibilities:

• Lead end‑to‑end clinical data management for assigned cardiovascular clinical trial in accordance with SOPs, GCP, and ICH Guidelines.
• Review study protocol and develop or review database definition files.
• Oversee creation of CRFs/eCRFs, Data Validation Plans, and Edit Check Specifications.
• Perform or oversee UAT of eCRFs and edit checks for databases in development.
• Manage change requests after database go‑live.
• Review CRF/eCRF for outsourced trials and generate queries as needed.
• Review edit check specifications, Data Management Plans, and Manual Review Guidelines for outsourced trials.
• Oversee Data Transfer Agreements with ancillary vendors.
• Ensure query resolution for outsourced trials and perform SAE reconciliation.
• Review data listings and manage cross‑functional data reviews to identify safety signals and support regulatory reporting, including DSUR and SUSAR.
• Provide Data Management summary reports and ad hoc reports to management and Clinical Operations.
• Ensure database close and lock at trial end.
• Resolve complex data issues to support interim analyses and timely decision‑making.

Experience Requirements:

• At least 5 years of clinical data management experience operating at the manager level.
• Sponsor‑side CRO oversight experience for Phase III studies.
• Biotech or pharmaceutical industry background.
• Cardiovascular experience preferred.
• Degree preferred.
• Ability to work fully remote with preference for proximity to Princeton, NJ or San Francisco, CA.