Sr Manager, Clinical Data Manager

Eliassen Group; United States; Hybrid; USD 90,000 - 96,000; Full time

Benefits offered by this job

Medical, Dental, Vision benefits

401k with company matching

Life insurance

Job summary

Eliassen Group's client, a small clinical-stage biotech focused on cardiovascular medicines, seeks a Senior Manager or Associate Director of Clinical Data Management to lead data management for a cardiovascular trial on a 12-month extendable engagement. Remote or hybrid work options available in Princeton, NJ or San Francisco, CA, with W2 benefits.

Responsibilities include end-to-end data management, CRF/eCRF design, EDC development, external data processing, and data review to ensure timely,

Qualifications

• At least 5 years of clinical data management experience at a managerial level.
• Sponsor-side CRO oversight experience for Phase III studies.
• Biotech or pharmaceutical industry background.
• Cardiovascular experience preferred.
• Degree preferred.

Responsibilities

• Lead end-to-end clinical data management for the cardiovascular 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.
• 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 SAE reconciliation.
• Review data listings and manage cross-functional data reviews to identify safety signals and support regulatory reporting.
• 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

Our client, a small clinical-stage biotech focused on cardiovascular medicines, seeks a Senior Manager or Associate Director level Clinical Data Manager for a 12-month 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.
• 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.