General Description:

Study management responsibilities:

• As part of the regional leadership team, provides strategic leadership, management, and/or mentorship to clinical study managers at various levels for assigned portfolio and may lead a designated therapeutic area or asset

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

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

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

• Ensures alignment of regional resources and deliverables with overall portfolio goals.

• Creates an environment that fosters innovation 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:

• Drives and influences improved standards of quality and efficiency for the region, promoting subject matter, disease area, or asset level expertise.

• 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.

• Collaborates with key stakeholders in the region and provides regular updates on portfolio progress in the region to senior management and Global Study and Program team as required.

• Forms high impact, cross-departmental teams within and across the region to ensure different perspectives, ideas and expertise are reflected when executing clinical trials.

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

• Displays therapeutic area knowledge and expertise of assigned portfolio and encourages individuals across the region to aspire to develop this expertise.

Line management responsibilities:

• Provides leadership, management, and/or mentorship to associate directors, clinical study managers at various levels for assigned portfolio

• Collaborates effectively with internal and external stakeholders within the region as well as with global stakeholders to ensure the needs of the business are met.

• Drives the overall Clinical Operations strategy for the region and is accountable for performance against key metrics

• Drives resourcing and capability development related to regional study management

• Ensures alignment of regional resources and deliverables with overall portfolio goals

Timelines, Planning and Execution

Study management responsibilities:

• Oversees the planning and management of the assigned clinical studies from feasibility through closeout activities for region, in line with global study timelines.

• Manages regional leaders to generate and maintain high quality study start up and recruitment timelines for region and tracks their progress to plan.

• Influences strategies to ensure that the clinical studies are operationally feasible in the region, enhances 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 and works to refine their templates.

• Drives a feedback-oriented culture, in which regional study managers are held accountable for coaching and mentoring CRAs to ensure proper study execution at the sites.

• 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 and influences regional study managers to improve metrics on data entry and query resolution.

• As required, oversees the planning and execution of the Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing.

Quality

Line management responsibilities:

• Ensures team members are trained on and are adhering to required processes and SOPs.

• Drives a quality mindset in the regional study management organization and supports the proactive implementation of risk management principles in the regional study management organization.

• Sets clear quality expectations for the regional study management organization.

• Drives the knowledge management and continuous improvement process by ensuring information is captured, retained, and leveraged in future work.

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.

• Engages effectively across regional leadership team to ensure cross-team, site learnings, and best practices are shared, promoting awareness and cross-functional collaborations that support the effectiveness of the organization.

• Improves workload management by supporting clinical study managers in setting priorities and by postponing less relevant work

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

Budget and Resources

Study management responsibilities:

• Demonstrates understanding of the department’s business levers that impact financial goals, and employs that knowledge to make critical business decisions for the department that support the region’s financial goals

• Works with the sourcing team to strategize on regional study vendor needs.

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

• Optimizes 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.

• Develops and implements effective coaching and mentoring processes that can be customized to support both junior team and senior team members and supporting their professional development plans.

• Conduct performance appraisals for direct reports which includes providing feedback.

Line management responsibilities:

• Conducts performance appraisals for direct reports which includes providing feedback

• Supports set up of development plans for direct reports

• Drives the hiring of new talent into the regional study management organization

Competencies: Leading level

• Embraces Change

• Communicates Effectively

• Drives Excellence

• Provides Leadership

• Team Player

• Mentors

• Manages Stakeholders

• Strategic Thinker

• Creates Innovation

• Learning / Growth Mindset

Computer Skills:

• MS Office, Project Planning Applications

Other Qualifications:

• Bachelor's degree in a scientific or healthcare discipline and 10+ years of progressive experience in clinical operations within biotech, pharmaceutical or CRO industry. Preferably master’s degree in a scientific or healthcare discipline and 7+ years of progressive experience in clinical operations within biotech, pharmaceutical or CRO industry.

• Solid leadership and extensive experience either as direct line manager (required for those with line management responsibilities) or as cross functional team lead

• Strong written and verbal communication skills

• Exercises sound judgement and discretion in matters of significance

• Ability to work independently and effectively handle multiple priorities in a fast-paced environment

• Excellent interpersonal skills, strong organizational skills and ability to influence and lead

Travel:

• Travel might be required as per business need.

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.