Clinical Operations Director
1 week ago
**Leadership Role:**
As a key member of the Clinical Operations team, the Associate Director, Regional Clinical Study Management will provide leadership and management to clinical study managers at various levels for assigned portfolios. This role will collaborate effectively with internal and external stakeholders within the region and globally to ensure the needs of the business are met. The Associate Director will contribute to the overall Clinical Operations strategy for the region and be accountable for performance against key metrics. Additionally, they will contribute to resourcing and capability development related to regional study management and ensure alignment of regional resources and deliverables with overall portfolio goals.**Key Responsibilities:**
Provide leadership to the team of Operations Managers and Operations Associates in charge of regional study management, including mentoring, coaching, and managing performance. Collaborate 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 broader organizational goals. Liaise and collaborate as required with external, global, and/or regional stakeholders such as FSP partners, clinical operations leaders in other regions, and monitoring heads in key countries in the region. Contribute to the overall Clinical Operations strategy for the region and have accountability for performance against key metrics. Support the development of initiatives and ensure that novel ideas on how to deliver on clinical trials are generated and considered.**Quality Focus:**
Ensure team members are trained on and adhere to required processes and SOPs. Promote a quality mindset in the regional study management organization and support the proactive implementation of risk management principles in the regional study management organization. Set clear quality expectations for the regional study management organization. Support the knowledge management and continuous improvement process by ensuring information is captured, retained, and leveraged in future work.**Budget and Resources:**
Contribute to the resourcing process for regional study management. Ensure 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:**
Conduct performance appraisals for direct reports, including providing feedback. Support the set-up of development plans for direct reports. Contribute to the hiring of new talent into the regional study management organization.**Computer Skills:**
MS Office, Project Planning Applications.**Other Qualifications:**
Solid leadership and management experience either as direct line manager or as cross-functional team lead. Strong written and verbal communication skills. Exercises sound judgment 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 may be required as per business need.**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.
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