Clinical Study Manager

General Description:

• Accountable forregion/countrystudy delivery(depending on the assignment)withappropriateinspectionreadinessquality, within agreed timelines and budget

• Leads theregional/countryclinical operationsteam(including oversight of external partners working on theregional/countrylevel)and acts as point of escalation for resolution of issues withinthe region for the assignedstudy

• Ensures alignment ofregional/countrydeliverables with overallstudy goals

Essential Functions of the job:

Regional/countryLeadership

• Leadstheregional/countryclinical operations team effectively,ensures effective decision making andacts asapoint of escalation fortheresolution ofissues within the region/countryfor the assignedstudy

• Leads external vendors involved in study delivery on aregional/countrylevel

• Collaborates withkeystakeholdersin the region/countryand provides regular updates on study progressin the region/countryto senior managementandGlobal/Region-focusedClinical Study Managerasrequired

• Representstheregional/countrystudy team at internal meetings andatthe cross-functional Clinical Study Team(CST)meetings

• Leadsregional/countryoperations meetings with allregional/countrystudy team members

Timelines, Planning and Execution

• Leads planning and management of the assigned clinical study(ies) fromfeasibilitythrough closeout activities for region/country, in line with global/regionalstudy timelines

• Generates, manages, andmaintainshigh-qualitystudystart-upandrecruitmenttimelinesfortheregion/countryand tracks progress towards these

• Ensures that the clinicalstudy isoperationallyfeasiblein the region/country,drivestrial feasibility, countryallocationand site selection processfortheassigned region/countryin collaboration withfeasibility managers, country heads, medicalaffairsand any other stakeholders

• Providesregional/countryinput on global/regionalstudy plans asrequired

• Ensurestimelyavailability oflocal adaptations of global/regionalstudy documents,such as informed consent forms, in close collaboration with other keystakeholdersto ensuretimelysubmission to regulatory authorities and ECs/IRBs

• Accountable for submissions of study in assigned region/countriesin close collaboration withregional/countrystudy start upteamand regulatory affairs

• Ensuresregional/country information in studysystems and toolsis entered and up to date

• Collaborates closely with CRAs in the region/countryto ensure properstudyexecution at the sites.Reviews andsigns off onmonitoring reports

• Responsible for working withregional/country teams to ensure that country and site level Trial Master File is created,maintainedandQC’dregularlyas per the study TMF QC plan

• Provides input to Global Clinical Suppliesregardingdrug inventories inthe region/country and reviews local drug labels for theregion/country.Provides input on localregulatoryapprovaland reimbursementstatus of comparator drugs used inthestudyfortheassigned region/country

• Manages the trial data collection process for the region/country, drives data entry and query resolution

• As required, supports planning and execution of the Clinical Study Report in collaboration with Global/Region focusedClinical Study Manager and Medical Writing

Quality:

• Handles escalatedissuesor problemswith the sitesin region/countryin close collaboration with stakeholders such as country heads

• Monitors study activities in region to ensure compliance withthe study protocol,SOPs, ICH/GCP and all other relevant regulations

• Ensures inspection readiness for study in region/countryat any point in time throughout the study life cycle

• InformsGlobal/Region focusedClinical Study Managerof any issues arisingon the study, evaluates impact and ensuressolutions are implemented

• Prepares sites for quality assurance audits and inspections, drivesresponses to audit and inspection findings as appropriate

• Collaborates withCST members andcolleagues to ensure cross-team, site learnings, and best practices are shared

• Leads improvements and partners withCSTmembers to enhance the efficiency and the quality of the work performed on assigned studies

• Contributes to development, optimizationand review of work instructions and SOPs asrequired

Budget and Resources

• Works with the sourcing team to select and manageregional/countrystudy vendors

• Managesregional/countrystudy budgets

• Works closely with Clinical Business Operation on investigator fees, site paymentissuesand patient travel reimbursement activities

• Identifiesand managesregional/countryteam resource needs andestablishescontingency plans for key resources

• Monitorsregional/countryresourceutilizationover study lifecycleand liaises with functional managers as needed

Supervisory Responsibilities:

• Provides performance feedback on team members asrequired

• Might mentorjunior team members

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Computer Skills: MS Office, Project Planning Applications

Other Qualifications:

• At least7years ofprogressive experience in clinical research within biotech, pharma or CRO industryincluded 2 years ofclinicalstudy management/team leadexperience

• Experience as CRA is preferred

Travel:

Travel might berequiredas per business need