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