Global Studies Manager---某欧洲制药公司全球研发中心


Job Description:


Provides direction and leadership to one ormore global Study Management Teams (SMTs)


Develops operational plans including sitemonitoring strategies, risk mitigation strategies, trial budgets, siteselection, and clinical supplies management


Builds and maintains effective andefficient high performing operations teams and ensures team members are awareof their accountabilities, responsibilities and deliverables


Creates team culture and promotes teamspirit


Develops and maintains effective workingrelationships with Study Management Team (SMT) members, with particular focuson affiliate teams, external CRO (for outsourced teams) and co-developmentpartner study teams


In collaboration with functionalmanagement, coaches, mentors, supports, and provides study specific directionto Study Management team members


Responsible for leading identification andselection of vendors; ensuring appropriate cross-functional input isincorporated into the scope of work


Responsible for assessing feasibility ofand driving execution/adherence to protocol amendments or changes to clinicalstudies, across functions


Responsible for leading identification andselection of vendors; ensures appropriate cross-functional input into the scopeof work


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


Ensures operational tracking tools areidentified, including systems to meet the needs of the operations team andensures reporting to the Global Studies Leader (GSL)




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


Establishes study milestones and ensuresaccurate tracking and reporting of study metrics such as initial recruitmentprojections


Provides operational input into thedevelopment of protocol feasibility questionnaires


Provides clinical operations expertise toensure operational feasibility and delivery


Leads the development and finalization ofsite feasibility questionnaires


Leads the creation of the study levelpatient recruitment plan and retention strategies based on feasibility data andinput from the affiliate teams and consultation with the GSL and OperationalProgram Leader (OPL)


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


Analyzes the feasibility data acrosscountries with input from the affiliates and makes recommendations to the GSLfor the strategic country and site distribution and patient numbers


Oversees forecasting ofclinical/non-clinical supplies


Designs drug assumption and supply chainprocess in partnership with Drug Supplies, affiliates and GSL


Oversees the forecasting and management ofnon-clinical supplies to ensure sites have supplies to run clinical study


Delivers the operational elements of thestudy plan


Chairs operations team meeting andorganizes investigator meetings, monitor training, CRO kick-off meetings


Ensures that reporting process of SUSARs isestablished and maintained for the duration of the study


Proactively manages actual study levelrecruitment versus planned patient recruitment status and communicates varianceto the GSL and implements contingencies in consultation with key stakeholders


Primary contact with affiliates to maintainoversight of performance, issues, their resolution and coordinates anycorrective action


Actively partner with Data Management andClinical Science to oversee eCRF completion and data quality issues


Ensures the completion and finalization ofany corrective and preventative action plans resulting from site audits, inconjunction with CCO, etc., as necessary


Oversees the maintenance of drug suppliesand resolution of issues with input from the Drug Supplies


Coordinates responses to study questions orissues from Health Authorities


Provides operational input into thedevelopment and tracking of SMT goals


Provides the day-to-day operationalmanagement of CROs and vendors to ensure delivery against contracted scope ofwork


Performs ongoing vendor management (e.g.,CROs, Central Labs, IxRS, etc.), including negotiation of scope of work,budgets, performance management, and issue resolution


Develops and supports appropriate site and CRO/vendoraudit and quality plans


Identifies areas of best practice andprocess improvements


Participates in Product Development GlobalOperations initiatives and programs as assigned


Maintains oversight and ensures consistencyof the operational aspects across studies within a project


Ensures study adherence to ICH/GCP and SOPs