Senior Clinical Data Manager

Worldwide Clinical Trials•Durham, NC

About The Position

Oversee, lead, manage, and provide technical expertise within the assigned projects to ensure that they are executed in an efficient, accurate, and timely manner to the Sponsor’s satisfaction.

Requirements

Excellent attention to detail.
Excellent written and verbal communication skills.
Strong knowledge of data management best practices & technologies as applied to clinical trials.
Excellent communication and interpersonal skills to collaborate with cross-functional internal and external teams.
Strong understanding of clinical trial process and protocols documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
Strong analytical and problem-solving skills.
Independent and autonomous project oversight skills.
Bachelor’s degree or higher in biomedical sciences, life sciences, computer science, or related discipline — or equivalent relevant experience.
Min of 5 years of experience in clinical data management or a related role within the pharmaceutical, biotechnology, or medical device industries.
Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.

Responsibilities

Provide fully independent and autonomous leadership of data management services (start up, conduct, and close out) across multiple complex global projects/programs, including:
Ensure appropriate resources are allocated to complete all DM activities on time and within budget.
Prepare DM trial documentation (DMP, DB Specifications, Edit check specifications, CCGs, DTAs).
Ensure effective UAT is performed.
Write external vendor reconciliation specifications for programming reconciliation outputs (e.g., Serious Adverse Events, IRT, Central Laboratory).
Oversee data cleaning activities.
Produce metrics to monitor the progress of trial activities.
Ensure all database lock activities are completed on time.
Represent WorldWide DM at both internal and external study meeting calls, including providing input.
Monitor project scope, budgets, and risks and alert DM Management of any concerns.
Liaise with DM Management at regular intervals to discuss progress and any issues outstanding (e.g., during Project Review Meetings).
Collaborate with internal Worldwide departments working on the same project.
Provide feedback on process improvements to DM Management and/or SMEs.
Participate in and lead process reviews.
Provide training, support, and mentorship to other members of the DM department.
Participate as necessary in sponsor audits, regulatory authority inspections, and other third-party meetings.
Perform other duties as assigned.
The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.