General Description:

Study management responsibilities:

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

• Acts as regional lead (if needed) for one or multiple studies across an indication or across a program as required.

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

• Contributes to the development of regional tools and leads the development of work instructions and SOPs as required.

• Drives deliverables regionally for trial or portfolio.

Essential Functions of the job:

Regional Leadership

Study management responsibilities:

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

• May oversee 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.

• Oversees the regional study team at internal meetings and at the cross-functional Clinical Study Team (CST) meetings.

• Develops and articulates regional goals, inspiring performance across teams, and develops cross-functional strategies that lead to study success.

• Displays therapeutic area knowledge and expertise of assigned portfolio.

Timelines, Planning and Execution

Study management responsibilities:

• Leads or oversees the 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.

• Drives strategy to ensure 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.

• Develops and implements effective coaching and mentoring to CRAs in the region to ensure proper study execution at the sites. May review and sign off monitoring reports.

• Guides the team 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.

• Anticipates and 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

Study management responsibilities:

• Anticipates potential concerns and resolves 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 study protocol, SOPs, ICH/GCP and all other relevant regulations.

• Ensures inspection readiness for studies in region at any point in time throughout the study life cycle.

• As regional study lead, informs Global Clinical Study Manager of any issues arising in the study, evaluates impact and ensures solutions are implemented. As portfolio lead, informs appropriate Global Clinical Study Managers and appropriate Global Clinical Program Leader of regional risk trends arising across portfolio of studies, evaluates impact and ensures solutions are implemented.

• As study lead, prepares sites for quality assurance audits and inspections, drives responses to audit and inspection findings as appropriate.

• Engages effectively with CST members and other colleagues to ensure cross-team, site learnings, and best practices are shared, promoting awareness and cross-functional collaborations.

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

• Leads the development, optimization and review of work instructions and SOPs as required.

Budget and Resources

Study management responsibilities:

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

• Manages and negotiates regional study budgets.

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

• Monitors regional resource utilization over study lifecycle and liaises with functional managers as needed.

Supervisory Responsibilities:

Study management responsibilities:

• Ensures the competencies and skills required for the Clinical team are consistent with the company defined requirements.

Mentor junior team members to support development by delegating responsibilities, overseeing and supporting development plans.

Education & Experience Required: Bachelor's degree in a scientific or healthcare discipline and 8+ years of progressive experience in clinical operations within biotech, pharmaceutical or CRO industry. Preferably master’s degree in a scientific or healthcare discipline and 6+ years of progressive experience in clinical operations within biotech, pharmaceutical or CRO industry.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.