Senior Clinical Project Manager

Dainippon Sumitomo Pharma • Atlanta, GA

416d • $137,100 - $171,500

About The Position

The Senior Clinical Project Manager at Sumitomo Pharma 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) and vendors to ensure compliance with study plans and regulatory requirements. The position requires strong leadership, communication, and project management skills to deliver quality clinical data and meet project timelines.

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

• Represents and leads the study team to design, develop and deliver the clinical study to agreed-upon timelines.
• Leads planning and communication with cross-functional teams to ensure proper execution and conduct of the clinical trial; generates quality clinical data.
• Serves as primary contact and resource for CRO and vendor personnel as well as team members in the parent company.
• Provides oversight and management of CROs, consultants, and vendors.
• Oversees and monitors the management of clinical studies ensuring compliance with agreed study plans through regular CRO and/or investigator site contact.
• Monitors progress of clinical activity and reports on the progress of assigned clinical trials including budget and timelines.
• Monitors the status of clinical data collection of assigned clinical trials.
• Prepares potential investigator site lists and assists with their evaluation for inclusion in the study.
• Prepares and reviews study-related documents when required.
• Reviews and approves study-related plans generated by CROs and vendors, ensuring compliance with GCP regulatory requirements and consistency with the protocol.
• Participates in the review and finalization of clinical study-related documents such as protocols, protocol amendments, clinical study reports (CSRs), regulatory submissions, and other publications.
• Participates in meetings such as Study Team Meetings, Investigator Meetings, Monitors' workshops, and CRO Training.
• Reviews correspondences and monitoring reports relating to the studies.
• Prepares and delivers program/study updates.
• Coordinates the delivery of clinical trial supplies in collaboration with CRO and other team members.
• Monitors budget for clinical study, reviews budgets and contracts with CROs, vendors, and investigator sites in collaboration with Finance and Legal team.
• Requests and critically evaluates proposals and change orders from CROs, vendors, and investigator sites.
• Provides input into contracts, work orders, and/or change orders.
• Manages escalation of study-related issues and communicates appropriately with management and other R&D functions.
• Anticipates potential study issues and prepares contingency plans with minimal oversight.
• Ensures assigned studies adhere to all applicable regulations and requirements.
• Provides input as the subject matter expert for assigned studies during regulatory inspections.
• Establishes collaborative and productive relationships with parent company, internal/external partners, and relevant affiliates.
• Evaluates issues found in clinical studies, communicates and oversees CROs and vendors, and suggests and implements solutions and mitigations.
• Evaluates CRO and vendor performance and supports improvement initiatives.
• Participates in the preparation, review, updating, and training of SOPs.
• Maintains knowledge of oncology therapeutic area, current medical practice, and pharmaceutical regulations.

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