[Hiring] Clinical Project Manager @Sumitomo Pharma America, Inc.

Role Description

The Clinical Project Manager is responsible for the planning, implementation, execution, and management of multiple clinical studies by overseeing day-to-day operations and directly managing outside Clinical Research Organizations.

Key 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 in overarching functions 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 they are conducted in compliance with the 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 the documentation is in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies.
• 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 as required.
• Participates in meetings – i.e., 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, and reviews budgets and contracts with CROs, vendors, and investigator sites (as applicable) in collaboration with Finance and Legal team.
• Requests and critically evaluates proposals and change orders from CROs, vendors, and investigator sites (as applicable).
• Provides input into contracts, work orders, and/or change orders.
• Manages escalation of study-related issues and communicates as appropriate with management and other R&D functions.
• Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight.
• Ensures assigned studies adhere to all applicable regulations and requirements.
• Provides input as the subject matter expert for the 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, communication, and oversight of CROs and vendors, and suggests and implements solutions and mitigations as required.
• 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 to ensure best practice across all activities.
• May mentor other team members.
• Performs other duties as requested by senior management.

Qualifications

• BS or MS in a related life science discipline is preferred.
• Minimum of 3 years of industry experience in clinical drug or program development or equivalent academic experience in clinical trials.
• 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.
• Thorough understanding of the oncology arena.
• 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.

Travel Requirements

• Primarily remote role with periodic on-site meetings in office.
• Must be able to travel domestically and internationally as needed.

Mental/Physical Requirements

• Fast-paced environment handling multiple demands is involved.
• Must be able to exercise appropriate judgment as necessary.
• Requires a high level of initiative and independence.
• Excellent written and oral communication skills required.
• Requires ability to use a personal computer for extended periods of time.

Benefits

• The base salary range for this role is $131,400.00 - $164,200.00.
• Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases.
• Short incentive plan participation.
• Eligibility for our 401(k) plan.
• Medical, dental, vision, life, and disability insurances.
• Leaves provided in line with your work state.
• Robust time-off policy includes flexible 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.
• Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education, and other factors permitted by law.