Regional Clinical Study Manager

General Description: 

• Accountable for regional study delivery with appropriate inspection readiness quality, within agreed timelines and budget 

• Leads the regional clinical operations team (including oversight of external partners working on the regional level) and acts as point of escalation for resolution of issues within the region for the assigned study 

• Ensures alignment of regional deliverables with overall study goals  

Essential Functions of the job:  

Regional Leadership 

• Leads the regional clinical operations team effectively, ensures effective decision making and acts as point of escalation for resolution of issues within the region for the assigned study  

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

• Collaborates with key stakeholders in the region and provides regular updates on study progress in the region to senior management and Global Clinical Study Manager as required 

• Represents the regional study team at internal meetings and at the 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) from feasibility through closeout activities for region, in line with global study timelines 

• Generates, manages, and maintains high quality study start up and recruitment timelines for region and tracks progress towards these 

• Ensures that the clinical study is operationally feasible in the region, drives trial feasibility, country allocation and site selection process for assigned region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders 

•  Provides regional input on global study plans as required 

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

• Accountable for submissions of study in countries in assigned region in close collaboration with regional study start up team and regulatory affairs 

• Ensures regional and country information in study systems and tools is 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 and QC’d on a regular basis as per the study TMF QC plan 

• Provides input to Global Clinical Supplies regarding drug inventories in region and reviews local drug labels for region. Provides input on local regulatory approval and reimbursement status 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, supports planning and execution of the Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing 

Quality: 

• Handles escalated issues or problems with the sites in region in close collaboration with stakeholders such as country heads 

• Monitors study activities in region to ensure compliance with the 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 

• Informs Global Clinical Study Manager of any issues arising on the study, evaluates impact and ensures solutions are implemented 

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

• Collaborates with CST members and colleagues to ensure cross-team, site learnings, and best practices are shared 

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

• Contributes to development, optimization and review of work instructions and SOPs as required 

Budget and Resources 

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

• Manages regional study budgets 

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

• Identifies and manages regional team resource needs and establishes contingency plans for key resources 

• Monitors regional resource utilization over study life cyle and liaises with functional managers as needed 

Supervisory Responsibilities:   

• Provides performance feedback on team members as required 

• Might mentor junior team members 

Computer Skills:     

MS Office, Project Planning Applications 

Other Qualifications:   

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

• Proven experience in clinical research including relevant experience as team lead in clinicial functions 

• Experience as CRA is preferred