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 assign ed 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 activitie s 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 stud y 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 escala ted 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

Travel:

Travel might be required as per business need