Senior Clinical Trial Manager - San Francisco - Diabetes

*** Diabetes experience required

*** Must be willing to work out of San Francisco office 3 days/week

The Senior Clinical Operations Leader is responsible for overseeing the functional team members and their activities across all geographies, liaising with the sponsor, project leadership, site management and all other related internal and external stake holders to ensure that the Clinical Operations deliverables are met on time, within budget, and with quality. The Senior Clinical Operations Leader has overall accountability for the execution of the clinical operations strategy and plan within the project and can competently and independently lead the clinical team.

The Senior Clinical Operations Leader may act in either a blinded/masked or unblinded/unmasked capacity based on business needs. The Senior Clinical Operations Leader must be willing and able to function as a Global Clinical Operations Leader independently when needed.

May act as Project Leader (Standalone Functional Leader) for projects involving limited scope of services, where no Project Leader is assigned.

This position is responsible for the global coordination of the clinical team on any size project(s) and therefore acts as a role model and/or coach for the team.

Additional responsibilities may include Clinical Operations Leader mentorship, participation in Clinical Operations Leader training and support, fulfilling subject matter expert roles within Clinical Operations, supporting business development opportunities, and involvement in departmental work streams when appropriate.

Sponsor Liaison

• Effectively communicate with internal and external customers as well as third party vendors.
• Build trusted partnerships with sponsor and other functional leaders
• Develop and recommend strategic solutions to internal team and sponsors to increase efficiencies and reduce costs, timelines, etc.
• Prioritize effectively and respond to urgent requests within team or from sponsor.
• Seek out opportunities to leverage relationships with clients for future sales

Project Initiation

• Oversee and/ or manage study start-up activities
• Provide inputs to project tools and study plans
• Provide input to the format and content for sponsor reports/templates, if applicable
• Provide input to and oversight of site selection strategy plan
• Develop site selection and monitoring plans
• Review and provide input into patient recruitment and retention plan
• Ensure all team members have access to study systems, tools and documents
• Establish efficient / effective working relationships with other Functional Leaders and colleagues across geographies within a given study/program
• Develop study plans, tools, forms and templates pertaining to Clinical Operations
• Provide input on relevant vendor plans, clinical supply strategy and management. Support vendor access and assist with troubleshooting vendor issues.

Project Execution

• Provide leadership and direction to project team members
• Identify, organize, and deliver (where appropriate) study specific training in collaboration with Project Leader and Project Specialists evaluate and identify resourcing needs and continuously monitor the use of resources over life cycle of project and/or program
• Provide study productivity targets to project team members
• Provide performance feedback on team members and work with line management, as appropriate
• To effectively recognize potential problem areas early and develop robust contingency and risk management plans,
• Own and drive study timelines, patient recruitment and retention, and data cleaning to ensure successful outcome of the project and/or program
• Proactively plan and manage large/complex or multiple projects within a program (ability to prioritize multiple timelines and deliverables simultaneously)
• Liaise with vendors to support clinical activities
• Oversee maintenance and quality check of TMF
• Maintain and ensure quality of work generated and escalate and follow up, as appropriate
• Ensure appropriate handover between clinical project team members with support from Clinical Operations Managers
• Implement and proactively initiate process improvements within the project and/or program, as and when needed
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