Regional Clinical Study Manager

General Description:

• Accountable for regional study delivery with appropriateinspection readinessquality, within agreed timelines and budget

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

• Ensures alignment ofregional deliverables with overallstudy goals

Essential Functions of the job:

Regional Leadership

• Leadstheregional clinical operations teameffectively,ensures effective decision making andacts as point of escalation for resolution ofissues within the region for the assignedstudy

• Leads external vendors involved in study delivery on a regional level

• Collaborates withkeystakeholdersin the regionand provides regular updates on study progressin the regionto senior managementandGlobal Clinical Study Manageras required

• Represents theregionalstudy team at internal meetings andatthe cross-functional Clinical Study Team(CST)meetings

• Leads regional operations meetings with all regional study team members

Timelines, Planning and Execution

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

• Generates, manages, and maintains high qualitystudy startup andrecruitmenttimelinesfor regionand tracks progress towards these

• Ensures that the clinicalstudy isoperationally feasiblein the region,drivestrial feasibility, country allocationand site selection processfor assigned region in collaboration withfeasibility managers, country heads, medical affairs and any other stakeholders

• Provides regional input on global study plans as required

• Ensures timely availability oflocal adaptations of global study documents such as informed consent forms, in close collaboration with other key stake holdersto ensure timely submission to regulatory authorities and ECs/IRBs

• Accountable for submissions of study in countries in assigned regionin close collaboration withregionalstudy start upteamand regulatory affairs

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

• Collaborates closely with CRAs in the region to ensure proper study execution at the sites.Reviews and signs-off monitoring reports

• Responsible for working with regional and country teams to ensure that country and site level Trial Master File is created, maintained andQC’don a regular basisas per the study TMF QC plan

• Provides input to Global Clinical Suppliesregarding drug inventories in regionand reviews local drug labels for region.Provides input on localregulatoryapprovaland reimbursementstatus of comparator drugs used in study for countries in region

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

• As required, supportsplanning and execution of the Clinical Study Report in collaboration withGlobal Clinical Study Manager and Medical Writing

Quality:

• Handles escalatedissuesor problemswith the sitesin region in 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 at any point in time throughout the study life cycle

• InformsGlobal Clinical 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 as required

Budget and Resources

• Works with the sourcing team to select and manage regional study vendors

• Managesregionalstudy budgets

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

• Identifies and managesregionalteam resource needs and establishes contingency plans for key resources

• Monitors regional resource utilization over study lifecyleand liaises with functional managers as needed

Supervisory Responsibilities:

• Provides performance feedback on team members as required

• Might mentorjunior team members

Computer Skills:

MS Office, Project Planning Applications

Other Qualifications:

• 4or more years of progressive experience in clinical research within biotech, pharma or CRO industry

• Provenexperience in clinical researchincluding relevant experience as team lead inclinicialfunctions

• Experience as CRA is preferred