Senior Clinical Project Manager

The Senior Clinical Project Manager (Sr. CPM) is responsible for leading and successfully delivering complex projects within Development Operations. This role involves close collaboration with stakeholders and cross-functional teams to ensure project scope, timelines, and quality standards are consistently met. The Sr. CPM is expected to work closely with internal teams and external partners, providing strategic business insights, assessing risks, and developing actionable implementation plans. The ideal candidate will have a strong background in managing intricate projects, possess exceptional leadership qualities, and demonstrate excellent communication skills.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Project Management: Oversee and support multiple projects, managing priorities, dependencies, scope, risks, and resources.
Timeline Development: Create integrated timelines across trials and functions, highlighting deliverables, competing priorities, and key milestones.
CRO Collaboration: Partner with Development Operations to discuss contract-related timelines, costs, and delivery expectations with CROs.
Program Oversight: Lead program and project reviews, ensuring all reporting requirements are met.
Risk Assessment: Collaborate with cross-functional teams to evaluate risks, define scope and budget, and develop comprehensive project schedules and plans.
Enrollment Management: Effectively model and manage patient enrollment forecasts, implementing risk mitigation strategies to keep enrollment on track.
Stakeholder Communication: Facilitate and manage cross-functional interactions with internal and external stakeholders, ensuring timely communication of information and materials for informed decision-making and adherence to study timelines.
Documentation Management: Develop and maintain key project management documents, including project plans, RAID logs, charters, and communication plans.
System Support: Manage and support SharePoint, Slack channels, Smartsheet, and other communication and tracking systems.
Reporting: Communicate project updates to stakeholders and escalate risks to the leadership team.
Portfolio Adherence: Ensure projects align with portfolio flow and that documentation and gate criteria meet project management standards.
Team Leadership: Foster a collaborative and high-performing project team environment, offering guidance, support, and mentorship to team members.
Process Improvement: Actively contribute to the development and implementation of best practices and standards for study management, and participate in Clinical Operations initiatives and process improvements.
Team Communication: Promote effective communication and teamwork among project members.

QUALIFICATIONS:

Education: BS/BA in physical sciences, Communication, Nursing, or a technical field (e.g., chemistry, engineering, biology, mathematics).
Experience: 10+ years of project management experience, with a focus on the pharmaceutical or biotechnology industry.
Expertise: Extensive experience in leading complex, cross-functional projects or programs, with a deep understanding of R&D, manufacturing, materials management, procurement, supply chain, quality, and regulatory affairs.
Skills: Proficiency in a wide range of disciplines, including business requirements analysis, project planning, scheduling, cost control, and economic analysis, to effectively manage projects and programs.
Time Management: Demonstrated skills in time management, particularly in calendar management and goal setting.
Technical Proficiency: Proficient in MS Office tools (PowerPoint, Word, Excel, Project, Visio) and other project management software such as SmartSheets.
Regulatory Knowledge: In-depth knowledge of governmental regulations, including FDA, EMA, and MHRA.

Preferences:

Strong knowledge of regulatory requirements.
Project Management Professional (PMP) certification from the Project Management Institute (PMI).

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Senior Clinical Project Manager