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DOCS Study Manager - Diagnostics - Remote in Pierre, South Dakota

Study Manager - Diagnostics - Remote

Ref #: 27351

Employment type: Permanent - Full-Time

Location: US- Nationwide


Main Responsibilities and Accountabilities:

• Provides direction and leadership to one or more global Study Management Teams (SMTs)

o Develops operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management

o Builds and maintains effective and efficient high performing operations teams and ensures team members are aware of their accountabilities, responsibilities and deliverables

o Creates team culture and promotes team spirit

o Develops and maintains effective working relationships with Study Management Team (SMT) members, with particular focus on affiliate teams, external CRO (for outsourced teams) and co-development partner study teams

o In collaboration with functional management, coaches, mentors, supports, and provides study specific direction to Study Management team members

o Responsible for leading identification and selection of vendors; ensuring appropriate cross-functional input is incorporated into the scope of work

o Responsible for assessing feasibility of and driving execution/adherence to protocol amendments or changes to clinical studies, across functions

o Responsible for leading identification and selection of vendors; ensures appropriate cross-functional input into the scope of work

• Contributes to the development and management of the study timelines, budget, risk and quality plans

o Ensures operational tracking tools are identified, including systems to meet the needs of the operations team and ensures reporting to the Global Studies Leader (GSL)

o Develops and manages clinical study budgets (including HQ budget). Communicates variances in the budget and action plan for resolution to the GSL

o Establishes study milestones and ensures accurate tracking and reporting of study metrics such as initial recruitment projections

o Provides operational input into the development of protocol feasibility questionnaires

• Provides clinical operations expertise to ensure operational feasibility and delivery

o Leads the development and finalization of site feasibility questionnaires

o Leads the creation of the study level patient recruitment plan and retention strategies based on feasibility data and input from the affiliate teams and consultation with the GSL and Operational Program Leader (OPL)

o Provides operational input and insight into all study related documentation (including protocol and informed consent form) and processes

o Analyzes the feasibility data across countries with input from the affiliates and makes recommendations to the GSL for the strategic country and site distribution and patient numbers


Life sciences degree or nursing equivalent.

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.