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

Role Description

Responsible for assisting the Clinical Project Manager (CPM) with the planning, implementation, execution, and management of multiple clinical studies by supporting the CPM in overseeing day-to-day operations and assisting as needed with the management of outside Clinical Research Organizations.

Job Duties and Responsibilities

• Supports the CPM to design, develop, and deliver the clinical study per agreed upon timelines.
• Assists in the planning and communication with cross-functional teams to ensure proper execution and conduct of the clinical trial; generates quality clinical data.
• Monitors the status of clinical data collection of assigned clinical trials.
• Assists with preparation of potential investigator site lists and assists with their evaluation for inclusion in the study.
• Prepares and reviews study-related plans and documents when required.
• Reviews study-related plans generated by CROs and vendors, and ensures the documents are 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.
• Prepares and delivers program/study updates as determined by project team.
• Coordinates the delivery of clinical trial supplies in collaboration with CRO and other team members.
• Supports CPM with review of change orders from CROs, vendors and investigator sites (as applicable).
• Provides input into contracts, work orders and/or change orders.
• Assists with review and management of invoice tracking/reconciliation.
• Ability to anticipate potential study issues and to prepare contingency plans in consultation with the CPM.
• Supports the CPM to ensure assigned studies adhere to all applicable regulations and requirements.
• Establish collaborative and productive relationships with parent company, internal/external partners and relevant affiliates.
• Identifies issues found in clinical studies, communication and oversight of CROs and vendors, and suggests and supports implementation of solutions and mitigations in consultation with the CPM.
• Participates in the preparation, review, updating and training of SOPs.
• Maintains knowledge of oncology therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities.
• May mentor other junior team members.
• Perform other duties as requested.

Qualifications

• Excellent 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 parent company in Japan.
• Interpersonal skills and influence to accomplish work without formal authority and to ensure optimal team performance.
• 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.

Requirements

• B.A. or B.S./M.S./Ph.D. in a related life science discipline is preferred.
• Minimum of 2 years of industry experience in clinical drug development or equivalent academic experience in clinical trials.
• Working knowledge of clinical trial conduct and applicable regulations, including ICH-GCP and FDA requirements.
• Understanding of clinical development processes, study start-up, conduct, and closeout activities.
• Strong organizational and project coordination skills with the ability to manage multiple priorities and timelines.
• Effective verbal and written communication skills with the ability to collaborate across cross-functional teams and external partners.
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint, Outlook) and clinical trial systems.
• Strong attention to detail and ability to maintain high-quality documentation and study records.
• Ability to identify issues, escalate risks appropriately, and support development of mitigation plans.
• Demonstrated ability to work independently while contributing effectively in a team environment.
• Experience with TMF oversight, trial metrics, and study tracking tools.
• Experience in oncology clinical trials preferred.

Benefits

• Base salary range: $108,500.00 - $135,600.00.
• Opportunity for merit-based salary increases.
• Short incentive plan participation.
• Eligibility for 401(k) plan.
• Medical, dental, vision, life and disability insurances.
• 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.