Senior Clinical Operations Manager

Proclinical is currently recruiting for a Senior Clinical Operations Manager for a global biotechnology company located in Cambridge, MA. Successful candidate will oversee one or more trials by establishing the operational strategy and securing excellence in execution through the CRO partner.

Job Responsibilities:

• Develop scientifically robust, operationally feasible and clear protocol concepts and protocols, and feasible protocols and robust data monitoring plans
• Leverage appropriate on going data review to identify and mitigate patient, study design, data or study conduct issues
• Ensure all operational aspects support end point integrity and data validity. Has a robust understanding of the study design including rationale, end points and patient population, and will ensure that the operational strategy supports both feasibility and scientific integrity. Leverages Phase expertise (e.g. Phase I, II, III, IV), therapeutic knowledge, as well as internal and external data to develop protocols and expert operational strategy for one or more clinical studies.
• Strive for effective, consistent, efficient and compliant processes by:
• Champion best practice development in Phase planning and seeks opportunities for innovation and efficiency with the Clinical Operation Management group
• Seek interdependencies and synergies with other trials and programs to enhance superb planning and execution across all studies in a phase
• Follow established procedures and SOPs; seeks ways to improve and streamline processes to support the GCO CRO outsourcing model
• Embody a culture of continual improvement by seeking consistency and efficiency in processes and fully supporting the new CRO partnership model.

Skills and Requirements:

• 10 years of clinical research study management experience of which 4+ years has been with a sponsor company managing outsourced clinical trials within quality, timeline, and budget expectations a plus.
• Prior CRO or investigator site and/or monitoring experience is a plus.
• Deep understanding of clinical development within one or more Phases of trials (Phase I, II, III, IV) and a working understanding of cross functional drug development.
• Scientific learning agility to quickly develop a sound working knowledge of new therapeutic areas.
• Ability to establish operational plans and support the CRO in the execution of the plans. Requires a balance of scientific and operational/project management and team leadership expertise.
• Must be able to build effective relationships across and up and down the organization.
• Excellent project management skills, including risk assessment and contingency planning.
• Must have effective prior CRO management skills and be able to adapt to the GCO outsourcing model.
• Able to partner with other functions and both internal and external stakeholders.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Nikki Ranieri at (+1) 215-531-5288 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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