Clinical Project Manager

Clinical Project Manager (CPM)

Beaufort seeks a skilled Clinical Project Manager (CPM) to work alongside a top-notch team of clinical researchers. This is a unique opportunity to join a growing CRO where your leadership will directly impact trial success and client satisfaction.

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.

• 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.

• 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.

• Monitor and reconcile project budgets.
• Collaborate with finance teams to provide accurate forecasts and manage scope creep.
• Support financial performance analysis.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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., Veeva Vault), and project management tools (e.g., MS Project, Smartsheet)
• Committed to ethical conduct, client satisfaction, and continuous improvement.

• 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.

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 in 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.