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Role Description

The Clinical Project Manager (CPM) is responsible to support and oversee the day-to-day responsibilities of multiple early phase regional clinical trials from protocol conception, start-up through the clinical study report, including all aspects of project document development, budget, safety, and quality in an environment where problem solving, critical thinking, teamwork and flexibility are vital to success.

• Support the planning and setup, maintenance and closeout phases of multiple concurrent clinical research studies
• Proactively manage all aspects of the trial process including vendor selection, site feasibility and selection, trial clinical timelines, clinical budgets, resources, and vendor relationships
• Provide day-to-day study management including oversight of CRO, study vendors and investigational sites in coordination with various cross-functional team members and study team
• Monitor all work performed by external partners to ensure quality of service with respect to mutually agreed timelines and budget
• Support the drafting, review and updating of documents related to clinical development such as Clinical Trial Protocols, Informed Consent Forms, Investigator’s Brochure, Laboratory Manual, IMP Handling Manual, etc.
• Ensure effective project plans are in place and operational for each trial within trial appropriate SOPs
• Identify and mitigate risks and apply strong problem-solving skills to ensure timely resolution of all study related issues
• Manage, facilitate and/or monitor the completion of interdisciplinary project tasks including site monitoring/audits, CRF and database development/revision, data collection, patient safety/AE management, document management, statistical analysis/final report writing, and study close out
• Management of small or medium-sized projects or regional leadership of complex multi-center clinical research projects
• Oversee the study specific Trial Master File (TMF) and assist with periodic audit of the TMF
• Perform any other tasks/duties as assigned by management

Qualifications

• Bachelor’s degree in life sciences
• At least 2 years of relevant experience in Clinical Trial Project Management
• Strong understanding of all aspects of clinical trials; experience with early phase clinical trials (Phase 1 - 2), oncology and/or radiopharmaceutical experience preferred
• Ability to deal with multiple priorities with aggressive timelines
• Thorough knowledge of ICH GCP, drug development, clinical research industry practices and regulatory processes
• Strong analytical, organizational, planning, decision making, negotiation, and conflict management skills
• Ability to build and maintain successful professional relationships with internal cross-functional teams, vendors and investigational sites
• Fluent in Microsoft Office products (Word, Excel, SharePoint, Teams, etc.) and proficiency using electronic platforms (CTMS, eTMF)
• Regional start-up experience (site feasibility, ethics & regulatory submissions)
• Demonstrated ability to pivot study strategy quickly and lead teams in the right direction working in a fast-paced environment
• Experience in conflict resolution, clinical project management practice, risk management, and an understanding of project financials

Key Capabilities

• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
• Results-oriented: Driven to achieve goals and corporate objectives, with a strong focus on delivering measurable results
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
• Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills