Senior Clinical Project Manager

Dainippon Sumitomo Pharma • Lansing, MI

417d • $137,100 - $171,500

About The Position

The Senior Clinical Project Manager is responsible for the planning, implementation, execution, and management of multiple clinical studies, including global studies. This role involves overseeing day-to-day operations and managing relationships with Clinical Research Organizations (CROs) to ensure clinical trials are conducted efficiently and in compliance with regulatory requirements.

Requirements

• S./M.S./Ph.D. in a related life science discipline is preferred.
• Thorough understanding of the oncology arena.
• Minimum of 3-5 years of industry experience in clinical drug or program development or equivalent academic experience in clinical trials.

Nice To Haves

• Proven leadership skills, executive presence, maturity, emotional intelligence, and written/oral communication skills.
• Demonstrated skills working within a matrix environment.
• Ability to work collaboratively with others within and external to the company, including investigators, CROs, vendors, and team members in the parent company in Japan.
• Interpersonal skills and influence to accomplish work without formal authority and to ensure optimal team performance.
• Strong experience facilitating project team meetings, cross-functional communication and decision making, and ensuring alignment with internal and external stakeholders.
• Strong attention to detail and the ability to establish priorities, schedule and meet deadlines.
• Sound judgment, problem solving, leadership, and collaboration in selecting methods and techniques for obtaining solutions to problems.
• Familiarity with the design and conduct of clinical trials and project management in relevant therapeutic areas.
• Experience evaluating outcomes of clinical trials and basic knowledge of clinical trial outcome standards.
• Strong analytical skills with a data-driven approach to planning, executing, and problem solving.
• Working knowledge of current global regulatory requirements and guidelines for clinical trials.

Responsibilities

• Represent and lead the study team to design, develop, and deliver the clinical study according to agreed timelines.
• Lead planning and communication with cross-functional teams to ensure proper execution and conduct of the clinical trial; generate quality clinical data.
• Serve as the primary contact and resource for CRO and vendor personnel as well as team members in the parent company.
• Provide oversight and management of CROs, consultants, and vendors.
• Monitor the management of clinical studies ensuring compliance with agreed study plans through regular CRO and/or investigator site contact.
• Monitor progress of clinical activity and report on the progress of assigned clinical trials including budget and timelines.
• Monitor the status of clinical data collection of assigned clinical trials.
• Prepare potential investigator site lists and assist with their evaluation for inclusion in the study.
• Prepare and review study-related documents when required.
• Review and approve study-related plans generated by CROs and vendors, ensuring compliance with GCP regulatory requirements and consistency with the protocol.
• Participate in the review and finalization of clinical study-related documents such as protocols, protocol amendments, clinical study reports (CSRs), regulatory submissions, and other publications as required.
• Participate in meetings such as Study Team Meetings, Investigator Meetings, Monitors' workshops, and CRO Training.
• Review correspondences and monitoring reports relating to the studies.
• Prepare and deliver program/study updates.
• Coordinate the delivery of clinical trial supplies in collaboration with CRO and other team members.
• Monitor budget for clinical study, and review budgets and contracts with CROs, vendors, and investigator sites in collaboration with Finance and Legal team.
• Request and critically evaluate proposals and change orders from CROs, vendors, and investigator sites.
• Provide input into contracts, work orders, and/or change orders.
• Manage escalation of study-related issues and communicate appropriately with management and other R&D functions.
• Anticipate potential study issues and prepare contingency plans with minimal oversight.
• Ensure assigned studies adhere to all applicable regulations and requirements.
• Provide input as the subject matter expert for assigned studies during regulatory inspections.
• Establish collaborative and productive relationships with parent company, internal/external partners, and relevant affiliates.
• Evaluate issues found in clinical studies, communicate and oversee CROs and vendors, and suggest and implement solutions and mitigations as required.
• Evaluate CRO and vendor performance and support improvement initiatives.
• Participate in the preparation, review, updating, and training of SOPs.
• Maintain knowledge of oncology therapeutic area, current medical practice, and pharmaceutical regulations to ensure best practices across all activities.
• May mentor other team members.
• Perform other duties as requested by senior management.

Benefits

• Merit-based salary increases
• Short incentive plan participation
• Eligibility for 401(k) plan
• Medical, dental, vision, life and disability insurances
• Unlimited paid time off
• 11 paid holidays plus additional time off for a shut-down period during the last week of December
• 80 hours of paid sick time upon hire and each year thereafter

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Master's degree