Senior Clinical Project Manager

AMER • Fishers, IN

1d

About The Position

The Senior Clinical Project Manager (SCPM) reports to the Senior/Director of Clinical Operations who bears primary responsibility for the execution of Telix’s clinical trials. The SCPM is responsible for the successful execution of national and global clinical trials (early phase to registration) from protocol conception, start-up through the clinical study report, including all aspects of project document development, budget, safety, quality, and team management in an environment where problem solving, critical thinking, teamwork and flexibility are vital to success. The SCPM ensures completion of study deliverables and proactively identifies and resolves clinical project issues.

Requirements

• Bachelor’s degree in life sciences required, PMP preferred
• 5+ years of relevant experience in Clinical Trial Project Management required
• Experience with late phase clinical trials (Phase 3 - 4, registration trials), oncology and/or radiopharmaceutical experience preferred.
• Excellent oral and written communication, organizational, and problem-solving skills while working under strict timelines.
• Team oriented mindset and demonstrates ability to work with cross functional teams.
• Experience managing global clinical trials.
• Thorough knowledge of ICH Good Clinical Practice (GCP) and regulatory processes.
• Demonstrated ability to pivot study strategy quickly and lead teams in the right direction.
• Strong analytical, organisational, planning, decision making, negotiation, and conflict management skills.
• Fluent in Microsoft Office suite (Word, Excel, SharePoint, Teams, etc.) and experienced in working in mainly electronic record-keeping environment.
• Demonstrated leadership skills and ability to cultivate development of others
• Start-up experience (country and site feasibility, ethics & regulatory submissions in multiple regions (APAC, EMEA, NA))
• 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 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

Responsibilities

• Proactively managing all aspects of the trial process including vendor selection, site feasibility and selection, trial timelines, budgets, resources, and vendor relationships from protocol finalization through to study closeout.
• Forecast and identify opportunities to accelerate activities to bring spend forward or identify if spend will shift.
• Independently develop integrated study management plans with the core project team.
• Developing and managing all study-related documents such as study protocol, informed consent, clinical manuals, and implementing quality standards.
• Monitoring all work performed by the external partners to ensure quality of the service with respect to mutually agreed timelines and budget.
• Ensuring effective project plans are in place and operational for each trial within trial appropriate SOPs.
• Managing risks proactively and leading problem solving and resolution efforts
• Support the development and maintenance clinical SOPs & trial process’ as required.
• Developing project delivery strategy for RFPs.
• Lead in bid defense preparations.
• Understand project strategy and translate the agreed upon approach.
• Management of complex multi-national, multi-center clinical research projects
• Develop patient recruitment strategies
• Conduct contract and budget negotiations with sites and vendors
• Communicate trial status, issues, and mitigations to leadership and relevant cross-functional stakeholders
• Train study team members and act as mentor for CPMs
• Work independently with limited supervision
• Attend medical conferences and represent clinical operations through investigator engagement and/or presentations

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level