Clinical Study Manager

General Description: 

• Accountable for region/country study delivery (depending on the assignment) with appropriate inspection readiness quality, within agreed timelines and budget 

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

• Ensures alignment of regional/country deliverables with overall study goals  

Essential Functions of the job:  

Regional/country Leadership 

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

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

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

• Represents the regional/country study team at internal meetings and at the cross-functional Clinical Study Team (CST) meetings 

• Leads regional/country operations meetings with all regional/country study team members 

Timelines, Planning and Execution 

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

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

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

• Provides regional/country input on global/regional study plans as required 

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

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

• Ensures regional/country information in study systems and tools is entered and up to date 

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

• Responsible for working with regional/country teams to ensure that country and site level Trial Master File is created, maintained and QC’d regularly as per the study TMF QC plan 

• Provides input to Global Clinical Supplies regarding drug inventories in the region/country and reviews local drug labels for the region/country. Provides input on local regulatory approval and reimbursement status of comparator drugs used in the study for the assigned 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 focused Clinical Study Manager and Medical Writing 

Quality: 

• Handles escalated issues or problems with the sites in region/country 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/country at any point in time throughout the study life cycle 

• Informs Global/Region focused 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/country study vendors 

• Manages regional/country study budgets 

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

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

• Monitors regional/country resource utilization over study life cycle and liaises with functional managers as needed 

Supervisory Responsibilities:   

• Provides performance feedback on team members as required 

• Might mentor junior team members

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Computer Skills:    MS Office, Project Planning Applications 

Other Qualifications:   

• At least 7 years of progressive experience in clinical research within biotech, pharma or CRO industry included 2 years of clinical study management/team lead experience 

• Experience as CRA is preferred