Description:

The Senior Manager, Clinical Operations is responsible for development and execution of clinical operations and monitoring functions for Clinical Endpoint Studies and PK studies and assists as required for other types of clinical studies.

Essential Functions:

• Analyze and review budgets for clinical studies. Proactively plan for appropriate clinical operations budget consumption and guide project managers and CRA's in managing variances and in developing corrective fiscal action plans.

• Manage clinical resourcing process through continual evaluation of existing and future resource alternatives, pro-active planning and collaboration with clinical team in US and India.

• Manage and conduct Clinical Protocol Review activities of all clinical trials (US and non US) according to regional guidelines and interface with appropriate functional leadership to achieve positive outcomes.

• Develop and/or review clinical monitoring plans and oversee clinical monitoring activities.

• Oversee completion of clinical study reports.

• Participate in site and vendor audits, as required for sites both in US.

• Review and evaluated bioanalytical methods.

Additional Responsibilities:

• Performs other functions as required or assigned.

• Complies with all company policies and standards.

Education:

• Bachelors Degree (BA/BS):  Relevant scientific discipline - Required

• Master Degree (MS/MA):  Relevant scientific discipline - Preferred

Experience:

• 8 years or more experience in Clinical trials/Clinical Operations capacity is required. Leadership experience a plus.

• 10 years or more in Managing Complex Projects in Clinical Operations capacity is preferred.

Skills:

• Team player, able to collaborate cross-functionally. - Intermediate

• Effective presentation skills. - Intermediate

• Strong written and verbal communication skills including good command of English language. - Advanced

• Strong organizational and problem solving skills. - Intermediate

• Strong time management skills and ability to adjust priorities as needed. - Advanced

• Ability to work independently with a minimum of supervision. - Intermediate

Specialized Knowledge:

• Experience in MS Word, Excel, Outlook, Powerpoint, and Adobe Acrobat.