
Clinical Trials Manager
2 weeks ago
We're seeking a strategic leader to oversee clinical trials and programs in the region. As a key member of our team, you will be responsible for providing input into regional strategic plans, managing cross-functional study teams, and overseeing financial operations.
Develops and implements short- and long-range therapeutic area/functional area plans as appropriate, including supporting alignment and communications to other team members upon implementation.
Provides leadership, guidance, oversight, and therapeutic expertise for the successful management of all aspects of clinical trials.
Responsible for the strategic, operational, and financial oversight of all program(s) within the region.
Develops, implements, manages, and ensures completion of clinical trials within regional designated budgets and timelines.
Sets the regional strategic vision for assigned clinical trials/programs by working cross-functionally with all relevant stakeholders.
Assesses, on-boards, and manages regional contract research organizations (CROs) and other vendors to ensure success of assigned trials/programs, including requests for proposals (RFPs) and selection processes.
Contributes to the regional strategic implementation of Clinical Development Programs for specific programs as a member of the Clinical Sub-Team and may sit on the Global Development Team, dependent upon the program's priority and breadth.
Oversees regional representation of local Study Management Team (SMT) members and influences relevant stakeholders.
Performs regional strategic analysis of project status and issues; ensuring robust risk mitigation strategies are in place.
Anticipates complex obstacles and implements solutions to achieve project goals.
Solves problems relating to national regulations, guidelines, and investigator interactions.
Keeps all stakeholders appropriately and timeously advised on all aspects of project status and any issues.
Partners with General Managers within the JAPAC region and other key regional stakeholders to ensure seamless execution.
Ensures building of strong regional site partnerships through management of Clinical Site Partners within the region.
Uses all available tools to track, oversee, and communicate on program status to all key stakeholders.
Contributes leadership input into all regional study-related documentation, including study protocols.
Responsible for Clinical Operations activities conducted by the regional affiliates that are required by local regulations and/or usual practice to support clinical trials.
May contribute to standard operating procedure (SOP) development, implementation, and training as it relates to the region.
Ensures team's work complies with established practices, policies, and processes, and any regulatory or other regional requirements.
People Leader Path: Hires, develops, and retains diverse top talent on the team. Sets clear expectations for the team and individuals' direct reports. Coaches direct reports on their performance, development, and career interests. May play a central role in developing other people leaders.
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