Senior Manager, Clinical Project Management

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.

Key Responsibilities:

• Represents and leads the study team to design, develop and deliver the clinical study to agree 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 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, and ensures the documentations 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.
• Reviews correspondences and monitoring reports relating to the studies.
• Prepare and deliver program/study updates.
• Coordinates the delivery of clinical trial supplies in collaboration with CRO and other team members. · Monitors budget for clinical study, and review 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. · Establish 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.
• Evaluate CRO and vendor performance and support the improvement initiatives.
• Participate in the preparation, review, updating and training of SOPs.
• Maintain knowledge of oncology therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities.
• May Mentor other team members.
• Perform other duties as requested by the senior management.

Qualifications:

• 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, vendor