Join Our Team as a Senior Clinical Data Manager

Company: Precision for Medicine

Job Title: Senior Clinical Data Manager

Location: Multiple Locations Available with Occasional Travel

Position Summary

We are currently seeking a Senior Clinical Data Manager to manage and oversee all aspects of the clinical trial data management process from study start-up to post-database lock for assigned projects. This role requires adherence to Standard Operating Procedures, regulatory directives, and specific plans and guidelines.

Key Responsibilities

As a Senior Clinical Data Manager, your core responsibilities will include:

• Serving as the primary contact for data management on assigned clinical projects.
• Overseeing the project data entry process, including development of guidelines and training.
• Developing CRF specifications from clinical study protocols and coordinating stakeholder feedback.
• Conducting database build User Acceptance Testing (UAT) and ensuring database quality.
• Creating and maintaining essential data management documentation.
• Training clinical research personnel on study-specific CRFs, EDCs, and other project-related items.
• Reviewing and querying clinical trial data in accordance with the Data Management Plan.
• Coordinating with third-party vendors to support project timelines and deliverables.
• Identifying and resolving operational problems and issues within clinical studies.

Qualifications

Minimum Required:

• Bachelor's degree or equivalent combination of education and experience.
• Minimum of 8 years’ experience in clinical data management.
• Proficiency in Microsoft Office applications.
• Strong organizational and communication skills.
• Professional proficiency in English (both written and oral).

Preferred:

• Experience in clinical, scientific, or healthcare disciplines.
• Knowledge of medical coding dictionaries (MedDRA, WHODrug).
• Understanding of CDISC standards (CDASH, SDTM, ADaM).
• Experience with oncology and/or orphan drug therapeutic areas.

Why Precision for Medicine?

At Precision for Medicine, you will join a team committed to advancing life-changing treatments and therapies in healthcare and clinical trials. We are an Equal Opportunity Employer, valuing diversity and inclusion across our workforce.

Qualified individuals with disabilities who require reasonable accommodations during the application process or who have difficulty accessing the application and wish to request an alternative method for application are encouraged to contact Precision Medicine Group at [email protected].

We look forward to receiving your application and potentially welcoming you to our team!