Director, Regional Clinical Study Management

General Description:

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 resourcing and capability development related to regional study management

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

Essential Functions of the job:

Regional Leadership

Line management responsibilities:

• Provides leadership to the team of Associate Directors, Operations Managers and Operations Associates in charge of regional study management, including mentoring, coaching and managing performance.

• Collaborates with peers in the regional Clinical Operations leadership team to ensure smooth delivery of all trials in the region on time, with quality and in line with the broader organizational goals.

• Liaises and collaborates as required with external, global and/or regional stakeholders such as e.g., FSP partners, clinical operations leaders in other regions, and monitoring heads in key countries in the region.

• Drives the overall Clinical Operations strategy for the region and has accountability for performance against key metrics.

• Drives the development of initiatives and ensures that novel ideas on how to deliver on clinical trials are generated and considered.

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.

Budget and Resources

Line management responsibilities:

• Contributes to the resourcing process for regional study management. Ensures efficient resourcing addressing both study needs as well as individual development needs through the principle of assigning the right person to the right study at the right point in time.

Supervisory Responsibilities:  

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

Computer Skills:    

• MS Office, Project Planning Applications

Other Qualifications:  

• 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.

Education & Experience Required:   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.