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

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, Google Cloud Platform, 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, Google Cloud Platform, 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.

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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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