Job#: 3013805

Job Description:

Apex Systems is a world class technology services business that incorporates industry or insights and experience to deliver solutions that fulfill our clients’ digital visions.

Apex has an opportunity for an Senior Manager, Clinical Affairs Project Management. For applicants who are interested in this opportunity, send your updated resume to Mike Konjoian, Account Manager, at [email protected].

Here are the details:

Position: Senior Manager, Clinical Affairs Project Management

Location: Remote

Project Duration: 6 month contract with potential for extension.

Rate: Negotiable Based on Experience



JOB DESCRIPTION

The Senior Manager of Clinical Affairs Project Management is responsible for leading and executing complex clinical projects and initiatives across global markets. This role ensures strategic alignment, operational excellence, and compliance with regulatory standards throughout all phases of clinical study planning and execution. The position requires strong leadership, cross-functional collaboration, and the ability to manage multiple priorities in a fast-paced environment.

Responsibilities:

· Lead and oversee clinical project management activities for multiple studies, ensuring adherence to timelines, budgets, and quality standards.

· Manage and mentor Clinical Project Managers and support staff, fostering a culture of accountability and continuous improvement.

· Champion process improvement initiatives to optimize workflows, establish best practices, and ensure consistent, efficient project management across all clinical studies.

· Develop and implement project plans, risk mitigation strategies, and contingency plans.

· Serve as the primary liaison between Clinical Affairs and cross-functional teams (Medical Affairs, R&D, Regulatory, Quality, Legal, and Operations).

· Oversee vendor selection, contract negotiations, and performance management for CROs and other external partners.

· Ensure compliance with applicable regulatory requirements, including GCP, ISO 14155, and FDA guidelines.

· Monitor study progress, resolve complex issues, and escalate as needed to senior leadership.

· Contribute to protocol development, IDE submissions, and interactions with regulatory authorities.

· Prepare and present project status reports and key performance metrics to stakeholders.

· Performs other duties as required.

Education and Experience:

· Bachelor’s degree in Life Sciences, Health Sciences, or related field (advanced degree preferred).

· Minimum 8+ years of experience in clinical research or project management within the medical device or pharmaceutical industry.

· Proven experience managing global clinical trials and cross-functional teams.

· Strong knowledge of regulatory requirements and clinical trial processes.

· Diabetes experience highly desirable.

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.

Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our ‘Welcome Packet’ as well, which an Apex team member can provide.