Clinical Project Manager

**Must work on our W2.**

**NO C2C**

**This is a high-level position, please only apply if you meet the qualifications**

The Senior Clinical Project Manager is responsible for overseeing and successfully delivering complex projects for Development Operations. You will collaborate with stakeholders and cross-functional teams to ensure project scope is met on time with the highest level of quality. The Sr. CPM collaborates with internal teams and external partners, develops objective business perspectives, assesses risks, and creates measurable implementation plans. The ideal candidate will have a proven track record of managing complex projects, exceptional leadership abilities, and excellent communication skills.

**MUST HAVE STRONG ONCOLOGY BACKGROUND

ESSENTIAL DUTIES AND RESPONSIBILITIES:

· Manage and support multiple projects' priorities, dependencies, scope, risks, and project resources.

· Build integrated timelines across trials and functions to exhibit deliverables, competing priorities, major milestones.

· Collaborate with DevOps for CRO delivery discussion regarding timelime, cost and delivery per the contract.

· Lead program and project reviews, fulfilling reporting requirements.

· Collaborate with cross-functional teams to assess risks, define scope and budget, and develop project schedules and plans.

· Effectively model and manage patient enrollment forecasts; implement risk mitigation strategies to ensure enrollment remains on track

· Facilitate and manage cross-functional interactions with internal and external stakeholders to ensure relevant and timely communication of information and materials for decision making purposes as well as ensure adherence to study timeline.

· Build and maintain project management documents such as project plan, RAID (risks, actions, issues, and decisions) log, charter, and communications plan.

· Ownership and support of SharePoint, Slack channels, Smartsheet, and other communication & tracking systems.

· Communicate and report project updates to stakeholders and risk escalations to leadership team.

· Ensure projects adhere to portfolio flow, and documentation and gate criteria meet project management standards.

· Foster a collaborative and high-performing project team environment, providing guidance, support, and mentorship to team members.

· Actively contribute to and implement best practices and standards for study management; participate in the development of initiatives and process improvement within Clinical Operations

· Promote effective communication and teamwork among project members.

QUALIFICATIONS

· BS/BA in physical science, Communication, Nursing or technical field (such as chemistry, engineering, biology, mathematics)

· 10+ years project management experience with focus in pharmaceutical or biotechnology industry.

· Extensive experience in leading complex, cross-functional projects or programs with expertise in R&D and understanding of manufacturing, materials management, procurement, supply chain, quality, and regulatory affairs.

· Ability to apply a wide range of disciplines, including business requirements analysis, project planning, scheduling, cost control, and economic analysis, to manage projects and programs effectively.

· Demonstrated time management skills, particularly in calendar management and goal setting.

· Proficient in MS Office tools (PowerPoint, Word, Excel, Project, Visio) and other project management software such as SmartSheets.

· Well-versed in governmental regulations, including FDA, EMA, MHRA regulations

Preferences

· Strong knowledge of regulatory requirements

· Certification as a Project Management Professional by the Project Management Institute (PMI)