Senior Clinical Data Manager

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

📋 Description

• Oversee and manage all facets of the global clinical study data management process from initiation through database lock and support for regulatory submissions.

• Coordinate efforts with the DM Contract Research Organization (CRO), internal and external Biostatisticians, laboratory vendors, database programming, and trial operations to define and execute data management requirements.

• Develop and maintain processes pertaining to data compilation, tracking, maintenance, cleaning, and finalization.

• Create, execute, review, and manage data listings for laboratory and database information.

• Identify risks and report findings during ongoing studies to clinical management.

• Prepare materials and present to Clinical Research Associates (CRAs) and sites to ensure consistent and high-quality data capture.

• Facilitate and lead data cleaning activities, including issuing queries and providing guidance on query issuance and acceptable resolutions.

• Ensure that routine clinical data is complete, accurate, and consistent in structure.

• Coordinate weekly reconciliation with various vendors to ensure timely and quality data entry, lab completion, and compliance with eDiary data entry.

• Ensure that electronic Case Report Forms (eCRFs), Clinical Study Protocols (CCGs), Edit Checks, Standard Operating Procedures (SOPs), and Data Management Plans (DMPs) align with study requirements and assist with their updates.

• Assist with updates to the Medidata Rave EDC system, including associated User Acceptance Testing (UAT) and documentation updates.

• Collaborate with internal team members, CROs, and vendors to achieve project deliverables and timelines for clinical data acquisition, quality review, clinical study reports, regulatory submission documents, and other requirements.

• Work with Statistics and Clinical teams to manage regular Data Monitoring Committee (DMC) meetings, including timeline development, data cleaning, and management of EDC and lab data transfers.

• Support the study manager in tracking and managing database interim review and lock timelines, ensuring that Clinical Data Management (CDM) project milestones are achieved.

• Develop and maintain reporting metrics for the overall study team and upper management, tracking trends across different regions.

• Assist the clinical team with various ad-hoc tasks, such as newsletter preparation and CRA training.

• Support activities related to audit and inspection readiness at the study level.

• 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.

• At least 5 years of data management experience, including a minimum of two years with a Sponsor company.

• Familiarity and experience with Medidata Rave EDC software.

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

• Knowledge of interim analyses as well as freezing and locking databases.

• Exceptional communication and time management skills, with the ability to collaborate across multiple functional areas.

• Capability to prioritize workload and associated tasks effectively.

• The selected candidate must be self-reliant, proactive, and able to manage, own, and lead all aspects of data management while contributing to the overall study team.

🏝️ Benefits

• Equal employment opportunities regardless of age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability, or other protected class characteristics.

• Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities.