Program Clinical Data Manager

Worldwide Clinical Trials•Carolina, NC

1d•Remote

About The Position

The Program Clinical Data Manager independently leads clinical data management activities across complex global projects and programs, from study start-up through conduct and close-out. The role oversees timelines, resources, budgets, scope, risks, data cleaning, vendor reconciliation, and database lock activities, ensuring high-quality delivery that meets sponsor expectations. The position collaborates with sponsors and cross-functional teams and serves as a subject matter expert to strengthen departmental processes, training, and quality. It also includes mentoring colleagues, co-leading process improvement initiatives, supporting proposals and sponsor presentations, and contributing expertise during audits and regulatory inspections. This is a remote role open to candidates based in the United States, with collaboration across global teams and multiple time zones.

Requirements

Bachelor’s degree or higher in biomedical sciences, life sciences, computer science, or a related discipline, or equivalent relevant experience.
At least 7 years of experience in clinical data management or a related role within the pharmaceutical, biotechnology, or medical device industries.
Expert knowledge of clinical data management best practices and technologies as applied to clinical trials.
Advanced understanding of the clinical trial process and key study documents, including protocols, statistical analysis plans, CRFs, and study reports.
Ability to independently oversee complex projects, solve problems, analyze issues, and maintain strong attention to detail.
Excellent written, verbal, interpersonal, and cross-functional communication skills for working with internal teams, external partners, and sponsors.
Proficiency in English.

Responsibilities

Lead data management activities independently across multiple complex global projects and programs from study start-up through conduct and close-out.
Develop and oversee trial documentation, including Data Management Plans, database specifications, edit check specifications, CCGs, and Data Transfer Agreements.
Drive user acceptance testing (UAT), data cleaning, external vendor reconciliation, progress metrics, and timely database lock activities.
Manage data management resources, timelines, scope, budgets, and risks; escalate concerns and keep leadership informed of project progress.
Represent Data Management in internal and external study meetings and collaborate with sponsors and cross-functional teams.
Provide subject matter expertise, guidance, and training for assigned data management processes.
Drive quality issue resolution, root cause analysis, CAPAs, and updates to guidance documents.
Mentor Data Management colleagues and co-lead departmental process, quality, and efficiency initiatives.
Support business development through sponsor proposals and presentations.
Contribute data management expertise during sponsor audits, regulatory authority inspections, and other third-party meetings.