Global Studies Manager - Remote Based (440845)
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POST DATE 9/14/2016
END DATE 10/12/2016
South San Francisco, CA
JOB DESCRIPTIONJob Description:
OVERVIEW: Position Purpose:Leads and provides operational expertise and leadership to one or more cross-functional global Study Management Teams (SMTs)Accountable for timely and efficient delivery of all operational aspects of one or more studies through all phases (phase 1b-IV) and stages (start-up, conduct and close-down), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations. Main Responsibilities and Accountabilities:Provides direction and leadership to one or more global Study Management Teams (SMTs) to ensure delivery of all cross functional activities in line with the clinical development planBuilds and maintains effective high performing SMTs by ensuring clarity of roles, responsibilities, accountabilities and deliverables for membersChairs SMT meetings and other meeting involving external stakeholders (Investigator, Steering Committee, Vendors as appropriate).Primary SMT contact for key internal stakeholders e.g. Operations Project Leader (OPL)Develops operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies managementBuilds and maintains effective and efficient high performing operations teams and ensures team members are aware of their accountabilities, responsibilities and deliverablesCreates team culture and promotes team spiritDevelops 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 teamsIn collaboration with functional management, coaches, mentors, supports, and provides study specific direction to Study Management team membersResponsible for leading identification and selection of vendors; ensuring appropriate cross-functional input is incorporated into the scope of workResponsible for assessing feasibility of and driving execution/adherence to protocol amendments or changes to clinical studies, across functionsResponsible for leading identification and selection of vendors; ensures appropriate cross-functional input into the scope of workCreates and manages study timelines, budget, risk and quality plansDrives setting of study team goals and milestones and monitors progressEstablishes and maintains accurate study level timeline and milestones; ensures relevant systems are appropriately maintained 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)Accountable for developing and managing clinical study budgets (including HQ budget). Establishes study milestones and ensures accurate tracking and reporting of study metrics such as initial recruitment projections Provides operational input into the development of protocol feasibility questionnaires Provides clinical operations expertise to ensure operational feasibility and deliveryDrives setting of study team goals and milestones and monitors progressEstablishes and maintains accurate study level timeline and milestones; ensures relevant systems are appropriately maintained Leads the development and finalization of site feasibility questionnairesLeads 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)Provides operational input and insight into all study related documentation (including protocol and informed consent form) and processesAnalyzes 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 numbersOversees forecasting of clinical/non-clinical suppliesDesigns drug assumption and supply chain process in partnership with Drug Supplies, affiliates and GSLOversees the forecasting and management of non-clinical supplies to ensure sites have supplies to run clinical studyDelivers the operational elements of the study planChairs operations and cross-functional team meeting and organizes investigator meetings, monitor training, CRO kick-off meetings Ensures that reporting process of SUSARs is established and maintained for the duration of the studyProactively manages actual study level recruitment versus planned patient recruitment status and communicates variance to the GSL or OPL, as applicable and implements contingencies in consultation with key stakeholders Prior experience of working remotely (at least two years).
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