Clinical Project Manager

Rho Inc

3h

About The Position

Rho is hiring a Clinical Project Manager to join its US team. The Project Management function is responsible for planning, implementing, monitoring, executing, and closing clinical trial projects in compliance with Good Clinical Practices (GCP) and the standard procedures agreed upon in each client contract. The Clinical Project Manager provides leadership to project team members and ensures contractual expectations and obligations are met. The role may lead clinical projects independently or work alongside a global Project Lead on larger, complex, or global studies requiring multiple project managers.

Requirements

• Bachelor’s degree, preferably in life sciences or public health.
• At least 3 years of experience working in clinical project management, ideally within a CRO environment.
• Knowledge of clinical trial processes and client expectations.
• Ability to lead components of clinical projects, including study start-up and close-out; establish and manage project budgets; and develop project management plans.
• Understanding of protocol development and/or review, the drug development process, ICH-GCP guidelines, and federal regulations.
• Ability to proactively identify project issues and lead resolution within the team, with assistance; developing problem-solving skills, judgment, and ability to anticipate necessary action.
• Ability to make data-driven decisions and resolve issues proactively.
• Strong written, verbal, presentation, and communication skills, along with diplomatic negotiation skills.
• Ability to lead, coordinate, and motivate teams, and to delegate and prioritize work for oneself and team members.

Nice To Haves

• Experience in neurology, analgesia, respiratory, immunology, or dermatology.

Responsibilities

• Lead clinical projects, including managing cross-functional project teams and vendors, or work alongside a global Project Lead on larger, complex, or global studies.
• Establish and maintain project timelines; organize and lead project team meetings and manage follow-up.
• Develop and maintain project management plans, and review functional area plans and other project documents for consistency with each other and the scope of work.
• Establish and manage project vendor and site budgets; forecast budgets and activities; track out-of-scope activities; and ensure budget adherence by internal and external team members.
• Oversee vendor contracts and site budgets and contract amendments; manage the Investigator Grant Payment (IGP) process and ensure sufficient contracted funds support projected enrollment and site-related costs throughout the study.
• Negotiate client requests that change scope or present opportunities to expand business or scope.
• Manage cross-functional project resources, assign project tasks to staff and vendors, identify additional resource needs, provide timely and accurate performance feedback, and escalate issues to management as appropriate.
• Serve as the primary project and client liaison, providing timely, clear communication and appropriate customer service.
• Build and maintain positive client and stakeholder relationships; understand project requirements and satisfaction with progress and performance; and recognize opportunities to expand business or scope.
• Identify, evaluate, and manage project risks and study trends with internal and external stakeholders, escalating when appropriate.
• Coordinate inspection readiness by proactively managing project documentation, identifying compliance gaps, and participating in audits and inspections.
• Review project operational metrics, identify project risks and issues, and work with the project team to address concerns.
• Provide status updates to leadership and clients, including developing slides and presentations for project oversight meetings.
• Build relationships with global, cross-functional project team members.
• Train and mentor Project Management employees, including Project Managers, APMs, and Project Associates.
• May support Contracts and Proposals and Business Development teams with RFIs and RFPs, including participating in bid defenses.

Benefits

• Comprehensive benefits package for benefit-eligible employees, including medical, vision, and dental coverage, HSA, FSA, EAP, life and disability insurance, and 401(k).
• Paid time off.
• Paid holidays.
• Parental leave.
• Bereavement leave.
• A flexible approach that encourages work-life balance.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level