Beaufort seeks a skilled Clinical Project Manager (CPM) to work alongside a top-notch team of clinical researchers. We participate in an exciting and growing industry and that growth fuels the need to continue to build our team and support our mission.
This is a unique opportunity to join a growing CRO where your leadership will directly impact trial success and client satisfaction.
Position Summary
The Clinical Project Manager (CPM) leads the end-to-end delivery of clinical trials across diverse therapeutic areas, ensuring strategic alignment, operational excellence, and regulatory compliance. This role serves as a cross-functional leader and primary liaison between sponsors, vendors, and internal teams to drive successful trial outcomes.
Key Responsibilities
Clinical Trial Oversight & Leadership
- Provide strategic and operational oversight for assigned clinical studies from start-up through close-out.
- Lead the cross-functional project team (e.g., clinical operations, data management, statistics, safety, and medical writing) to meet or exceed project goals.
- Act as primary contact for Sponsors and serve as a Subject Matter Expert (SME) for designated clinical programs.
- Ensure compliance with ICH-GCP, SOPs, protocols, and regulatory requirements.
Project Management
- Create, manage, and maintain detailed project plans including timelines, deliverables, KPIs, and milestones.
- Track project performance using appropriate systems, tools, and techniques (e.g., project dashboards, risk logs, scope change trackers).
- Identify project risks and develop proactive mitigation strategies in collaboration with sponsors and internal stakeholders.
- Implement structured change control processes to manage protocol amendments or scope changes.
- Lead regular internal and sponsor-facing status meetings, ensuring clear communication of project progress, challenges, and action items.
Project Financial Management
- Monitor and reconcile project budgets.
- Collaborate with finance teams to provide accurate forecasts and manage scope creep.
- Support financial performance analysis.
Site and Vendor Management
- Oversee site selection activities and review feasibility data to make final recommendations.
- Provide oversight and guidance to CRAs regarding monitoring activities, site management, and issue resolution.
- Participate in or lead site qualification visits, initiation visits, interim monitoring visits, and close-out visits as needed.
- Manage vendor performance and coordinate outsourced service providers to ensure quality and timelines.
Documentation and Reporting
- Review and/or contribute to key study documents such as protocols, CRFs, monitoring plans, site manuals, and data management plans.
- Ensure timely development and delivery of study reports, metrics, and sponsor communications.
- Support regulatory submissions and audit readiness activities.
Team Support and Organizational Collaboration
- Mentor junior team members, support team knowledge sharing and contribute to performance feedback.
- Assist with onboarding, and training of new clinical operations staff.
- Provide support for business development activities, participate in bid defenses and potential client meetings as needed.
Qualifications
Education & Certifications
- Bachelor’s degree in biological sciences, pharmacy, nursing, or a related health discipline required; advanced degree preferred.
- Certification(s) such as PMP, CCRP, CCRA, or equivalent highly preferred.
Experience
- Minimum of 5 years’ experience in clinical research with at least 3 years in a project management role.
- Proven history of leading complex global or domestic clinical trials within a CRO or sponsor environment.
- Experience managing clinical studies in in vitro diagnostics (IVD) and Medical Device
- Applied deep knowledge of ICH-GCP and global regulatory requirements to ensure compliance across all phases of clinical trial execution.
Skills & Competencies
- Proven leadership and stakeholder management skills; able to influence across teams and drive project success.
- Skilled in managing multiple priorities and timelines in fast-paced, deadline-driven environments.
- Experienced in global trial execution with cultural awareness and adaptability.
- Comfortable navigating ambiguity, making independent decisions, and knowing when to escalate.
- Proficient in CTMS, eTMF (e.g., VeevaVault), and project management tools (e.g., MS Project, Smartsheet)
- Committed to ethical conduct, client satisfaction, and continuous improvement.
Work Environment & Expectations
- Must be able to work independently and collaboratively in a remote or office-based setting.
- Ability to travel occasionally to attend meetings, site visits, or client engagements.
Why Join Beaufort?
Beaufort offers a different CRO experience. It’s not just about what we do, it’s how we do it. Together our team brings a level of passion knowledge and commitment to our projects and clients. We foster a culture of excellence clinical project management and regulatory support.
At Beaufort you will be part of industry leading expertise with a shared sense of purpose and unwavering accountability to help clients achieve successful market authorization.
Beaufort is an equal opportunity employer and values diversity. We offer a highly competitive compensation and benefits package.