Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, and a diverse pipeline of early- to late-stage 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.

Job Overview

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Senior Manager, Study Start-Up, Oncology. /The Senior Study Start-up (SSU) Manager is responsible for the delivery of site start up activities for assigned studies from site identification through activation working in collaboration with the CPM and is an active member of the study team(s). Senior Manager, Study Start-Up reports to Director, R&D Operations and/or VP of Clinical Operations and Data Management, Oncology.

KEY RESPONSIBILITIES:

• The SSU Senior Manager works in collaboration with CPMs, CRAs, Clinical Business Operations, Medical Affairs, study sites, study team and CRO, if applicable, to ensure that site activation is achieved in a timely and efficient manner based on timelines set by the study team and in consideration of local activation process requirements.

• Produces the study site activation plan across countries and sites based on the study priorities detailing country and site-specific requirements and planned dates.

• Continuously updates study activation plans identifying risks and mitigation plans. Reviews and modifies study start-up processes to ensure quality and efficiency.

• Assists applicable functions and CROs as applicable with regulatory interactions related to submissions and approval processes across multiple countries.

• Obtains and maintains essential documentation in compliance with ICH-GCP and ensures filed in TMF.

• In collaboration with CPM, CBO and other relevant stakeholders (i.e., Legal, ClinOps, etc.), assists in negotiations of budget and contract with resolution of issues and contract execution.

• Assists in producing and collecting site-specific contracts, ICFs and CDAs from country and/or master template.

• Assists in communicating Site prioritization regarding Study Site Contract completion/execution to meet Study Activation Plan.

• Tracks and reports metrics of study site progress towards activation at relevant meetings.

• Proactively identifies delays in start-up activities, the risks to the activation plan and develops collaborative mitigation strategies for the study team to implement.

PROFESSIONAL EXPERIENCE/QUALIFICATIONS:

• Minimum of 3-5 years of industry experience in clinical drug or program development or equivalent academic experience in clinical trials.

• Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.

• Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.

• Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification. Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.

• Excellent negotiation skills.

• Ability to work collaboratively with others within and external to the company, including investigators, Site Coordinators, CROs, vendors and team members in parent company in Japan.

• 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.