As the Study Start Up Manager you will be responsible for providing customer-focused execution of the operational strategy and management of start-up activities for projects or programs.
This includes the overall management and oversight of the following processes : site feasibility, regulatory approval, and site contracts.
May be assigned to manage the site start-up activities for a country, region, or entire global trial.
This role also has responsibility for maintaining internal tracking for study site status from initial site contact through site initiation.
This position will primary work with local study managers in the LOCs, SDLs in Rx and Vx Delivery and the Feasibility and Recruitment Planning Managers.
Please note that Study Start Up Manager has no direct reports.
Key Responsibilities :
Serve as SSU Specialist for Assets and Studies.
Develops with key stakeholders (TA Leads, SDL, Locs, Feasibility & Recruitment Planning Managers) a study specific SSU plan.
Communicates overall site activation status to SDL and study team
Works key stakeholders to establish regulatory requirements and contracts necessary for start-up.
Where applicable, provide work instructions to team members in preparation of regulatory submissions.
Establishes processes for the collection and initial review of regulatory packets and site contracts for investigator sites.
Facilitates communication within the clinical team (e.g. SSU tea, study team members, Clinical, Regulatory Affairs, Vendors, ) during site start up, closely monitoring site visit schedule to ensure site activation timelines are met.
Implement Monitoring processes that are effective in providing high quality deliverables to our internal and external teams.
Directs the development of study start up Review plans. Assures team members incorporate required elements of the Regulatory Plan and Monitoring Plan in accordance with Good Clinical Practices (GCP)
Contribute to the design, development, and update of Standard Operating Procedures & WPs for all SSU activities.
Maintain and manage SSU data tracking entries in database. Review for completeness and accuracy.
Review and provide feedback to management on site performance metrics.
Developing appropriate early warning systems of potential obstacles to the successful completion of study start-up; analyzes information and develops innovative solutions to challenges
Responsible for escalation of issues and reporting progress to study teams and clinical management weekly, including plans for addressing / mitigating risks / gaps.
Maintains current knowledge of relevant country regulations, and GCP and ICH Guidelines for clinical research.
Contribute to process improvement efforts both within the department and in cooperation with other departments
Transition oversight accountabilities to the SDL at the end of the start-up phase
Basic Qualifications :
Work experience with investigator start-up documents and investigative sites is required
Work experience in the clinical research field and a strong working knowledge of the ICH and FDA guidelines and of the IRBIIEC regulations is expected
Previous healthcare experience is preferred
Experience working with cross functional teams
Strong computer skills required
The ability to analyze and review data (in order to build evidence-based trial strategies)
Capable of multi-tasking and working well under pressure to meet deadline coupled with a good understanding of working in a team environment
Bachelor's Degree in relevant field
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