Senior Clinical Data Manager

Worldwide Clinical Trials; North Carolina; On-site; USD 79,000 - 157,000; Full time

Job summary

Worldwide Clinical Trials is seeking a Senior Clinical Data Manager to lead data management services across multiple global projects. You will oversee startup through closeout, ensuring resources, timelines, and budgets are met while maintaining data integrity.

You will author essential DM documents, coordinate with QA, and mentor team members to drive process improvements and successful audits. This role requires strong collaboration with internal and external stakeholders.

Qualifications

• Strong knowledge of data management best practices for clinical trials.
• Excellent written and verbal communication skills.
• Independent and autonomous project oversight required.
• Experience with DM processes, databases, and trial documentation.

Responsibilities

• Provide independent leadership of data management services across global projects.
• Ensure resources are allocated to complete DM activities on time and within budget.
• Prepare DM documentation (DMPs, Database Specifications, Edit Check Specs, CCGs, DTAs).
• Ensure effective User Acceptance Testing (UAT) is performed.
• Write vendor reconciliation specifications for programming outputs (SAEs, IRT, Central Lab).
• Oversee data cleaning activities and ensure on-time database lock.
• Produce metrics to monitor trial progress and risks.
• Represent DM in study meetings and liaise with DM management.

Skills

Leadership

Data management

Communication

Analytical thinking

Project oversight

Budget awareness

Collaboration

Education

Bachelor’s degree or higher in biomedical sciences or related field

Job description

What The Senior Clinical Data Manager Does At Worldwide

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

What You Will Do

• Provide fully independent and autonomous leadership of data management services (start-up, conduct, and closeout) across multiple complex global projects/programs


• Ensure appropriate resources are allocated to complete all data management (DM) activities on time and within budget


• Prepare DM trial documentation, including Data Management Plans (DMPs), Database Specifications, Edit Check Specifications, CRF Completion Guidelines (CCGs), and Data Transfer Agreements (DTAs)


• Ensure effective User Acceptance Testing (UAT) is performed


• Write external vendor reconciliation specifications for programming reconciliation outputs (e.g., Serious Adverse Events, Interactive Response Technology (IRT), Central Laboratory)


• Oversee data cleaning activities


• Produce metrics to monitor progress of trial activities


• Ensure all database lock activities are completed on time


• Represent Worldwide Clinical Trials Data Management 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 outstanding issues (e.g., during Project Review Meetings)


• Collaborate with internal Worldwide Clinical Trials departments working on the same project


• Provide feedback on process improvements to DM Management and/or Subject Matter Experts (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.

What You Bring To The Role

• Excellent attention to detail


• Excellent written and verbal communication skills


• Strong knowledge of data management best practices and 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 processes, protocol documents (protocols, Statistical Analysis Plans (SAPs), Case Report Forms (CRFs), study reports), and related procedures


• Strong analytical and problem-solving skills


• Independent and autonomous project oversight skills

Your Experience

• Bachelor’s degree or higher in biomedical sciences, life sciences, computer science, or a related discipline, or equivalent relevant experience


• Minimum 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.

At Worldwide Clinical Trials, we are committed to fostering an inclusive and equitable workplace by providing transparent compensation.

The salary range for this position is annually (For hourly paid positions, the stated salary range reflects hourly rates):

United States of America - $79,000.00 - $157,000.00

The salary range provided is intended to give candidates an understanding of potential earnings. Compensation will fall within the provided range, and it not a guarantee of exact salary. The final salary will be determined based on relevant experience, performance, education, and internal equity. In addition to base salary, we offer a competitive benefits package depending on location. We ensure pay equity and transparency and comply with all applicable labor laws. Salary information will be discussed during the interview process, and we encourage candidates to inquire about compensation at any stage.

We love knowing that someone is going to have a better life because of the work we do.

To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.