Senior Clinical Project Manager

Role Summary

Senior Clinical Project Manager responsible for the overall management and coordination of operational activities involved in planning, conducting and completing clinical trials, including deliverables, budget adherence, and risk mitigation. Manages selected CROs and leads cross-functional project teams to ensure on-time, on-budget, high-quality project delivery.

Responsibilities

• Drive the planning, development, and execution of timelines while identifying and tracking the team’s critical path.
• Facilitate the project team kick-off meeting by identifying key stakeholders and resources.
• Execute and control project activities, including scope, schedule, budget, and risk, and report performance to senior management.
• Establish communication plans for information distribution to team members.
• Manage project/program meetings.
• Conduct project/program reviews at significant milestones or gates to evaluate successes as compared to baseline estimates.
• Integrate understanding of constraints across and within projects and recommend alternatives.
• Identify and track key study metrics to anticipate issues and conduct root-cause investigations for issue resolution or escalation as needed.

Qualifications

Education/Experience:

• Bachelor’s degree or equivalent in the life sciences or related field required. Additional coursework or certifications in clinical trial planning and operations desired.
• At least 5 years experience as a global clinical project manager.
• Experience in rare disease preferred.
• Experience working in a fully outsourced model.
• Experience in small, fast-paced biotech is a plus.
• Experience coordinating interdepartmental activities and efforts to meet protocol and program goals.
• Expert and extensive knowledge of CRO/vendor management and global protocol operations.

Knowledge, Skills And Abilities

• Working knowledge of GCP, ICH guidelines, and regulations.
• Proficiency in resource planning and financial management (clinical trial budgeting).
• Ability to manage multiple priorities with aggressive timelines.
• Strong oral and written communication skills.
• Strong interpersonal skills to build relationships with investigators, site staff, and CROs.
• Ability to work with minimal supervision, take initiative, meet deadlines, and resolve/escalate problems timely.
• Ability to find creative solutions to issues impacting timelines and budgets.

Additional Requirements

• Willingness and ability to travel domestically and internationally (approximately 10% of work time).