Clinical Project Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee clinical projects, which may involve cross-functional project teams and vendors, or collaborate with a global Project Lead on more intricate or large-scale studies.

• Set and uphold project timelines.

• Facilitate and conduct project team meetings, ensuring proper follow-up.

• Create and sustain project management plans.

• Evaluate functional area plans and project documents for consistency and alignment with the scope of work.

• Establish and supervise project vendor and site budgets.

• Anticipate budgets and activities, while monitoring out-of-scope activities.

• Ensure compliance with budget constraints by both internal and external team members.

• Oversee vendor contracts, site budgets, and any amendments to contracts.

• Manage the Investigator Grant Payment process.

• Negotiate client requests pertaining to changes in scope or business expansion.

• Coordinate resources across different functions and delegate tasks to staff and vendors.

• Identify additional resource requirements and provide performance evaluations.

• Act as the primary liaison between the project and clients.

• Foster and sustain positive relationships with clients and stakeholders.

• Identify, assess, and manage project risks and study trends.

• Organize inspection readiness initiatives and engage in audits and inspections.

• Review operational metrics and address project risks and issues.

• Provide progress reports to leadership and clients, including slides and presentations for oversight meetings.

• Cultivate relationships with global, cross-functional project team members.

• Train and mentor Project Management personnel, including Project Managers, APMs, and Project Associates.

• Assist Contracts and Proposals and Business Development teams with RFIs, RFPs, and bid defenses.

⛳️ Requirements

• Bachelor’s Degree, preferably in life sciences or public health.

• A minimum of 3 years of experience in clinical project management, ideally within a CRO setting.

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

• Familiarity with clinical trial processes and client expectations.

• Capability to lead various segments of clinical projects, including study initiation and closure.

• Proficiency in establishing and managing project budgets and developing project management plans.

• Understanding of protocol development and/or review processes.

• Knowledge of the drug development process, ICH-GCP guidelines, and federal regulations.

• Ability to proactively identify project challenges and guide resolution efforts within the team.

• Strong problem-solving skills, judgment, and the capacity to foresee necessary actions.

• Competence in making data-driven decisions and addressing issues proactively.

• Excellent written, verbal, presentation, and communication skills.

• Diplomatic negotiation abilities.

• Capability to lead, coordinate, and motivate teams.

• Proficiency in delegating and prioritizing tasks for oneself and team members.

🏝️ Benefits

• Medical insurance.

• Vision insurance.

• Dental insurance.

• HSA.

• FSA.

• EAP.

• Life and disability insurance.

• 401(k).

• Paid time off.

• Holidays.

• Parental leave.

• Bereavement leave.

• Flexibility for work-life balance.

• Opportunities for career advancement.

• Financial incentives.