Senior Clinical Data Manager – Contract

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Oversee and handle all components of the global clinical study data management process from the initiation of the study to database lock and regulatory submission assistance.

• Coordinate data management tasks with the DM Contract Research Organization, internal and external biostatistics, laboratory vendors, database programming, and trial operations.

• Create, execute, review, and sustain laboratory and database data listings.

• Identify risks and highlight findings during ongoing studies; develop materials and present them to CRAs and sites to ensure consistent and high-quality data capture.

• Lead data cleaning efforts, including issuing queries and providing direction on query issuance and acceptable resolutions.

• Ensure the completeness, accuracy, and consistency of routine clinical data and its structure.

• Coordinate weekly reconciliations with multiple vendors for timely and quality data entry, laboratory completions and results, as well as eDiary entry and compliance.

• Ensure eCRFs, CCGs, edit checks, SOPs, and DMPs align with study requirements and assist with necessary updates.

• Support updates to the Medidata Rave EDC system, including associated UAT and documentation.

• Collaborate with internal teams, CROs, and vendors to meet deliverables and timelines for clinical data acquisition, quality review, clinical study reports, and regulatory submission documents.

• Work with Statistics and Clinical teams to manage DMC meetings, timelines, data cleaning, EDC and laboratory data transfers, and related activities.

• Assist the study manager in tracking database interim reviews and lock timelines, as well as meeting CDM milestones.

• Develop and maintain reporting metrics for the study team and upper management, including monitoring trends across various regions.

• Support ad hoc clinical team activities such as newsletter preparation and CRA training.

• Facilitate study-level audit and inspection readiness activities as necessary.

• Perform additional duties as assigned.

⛳️ Requirements

• Bachelor’s degree in biological sciences, biometrics, mathematics, or a related field, or an equivalent combination of experience and education.

• A minimum of 5 years of experience in data management, with at least 2 years at a sponsor company.

• Proficiency and familiarity with Medidata Rave EDC software.

• Knowledge and experience with Phase I, II, and III trials, preferably on a global scale.

• Familiarity with interim analyses and the processes of freezing and locking databases.

• Strong communication and time management skills, including the ability to collaborate across various functional disciplines.

• Capable of prioritizing study loads and associated tasks effectively.

• Must be self-sufficient and independent, demonstrating initiative while managing, owning, and leading all aspects of data management, contributing to the overall study team.

🏝️ Benefits

• Contract role.

• Full-time schedule.

• Equal employment opportunity protections.

• Commitment to compliance with federal, state, and local laws.