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Clinical Trial Operations Director

Company:
Fraser Dove International
Location:
New York, NY
Posted:
May 11, 2024
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Description:

Clinical Trial Operations Director

Fraser Dove International is partnering exclusively with an AI-based remote diagnostics organisation. Operating in the US, they are committed to empowering medical professionals with scored, clinical-grade diagnostic data.

Our client is seeking a forward-thinking leader to oversee clinical trials.

Discover more about our Clinical Trial Operations Director opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.

Your objectives:

As the Clinical Trial Operations Director, you will be measured against the following objectives:

efficient and compliant management of clinical trials across CROs while maintaining regulatory adherence.

strong clinical operations and project execution aligned with commercial goals, overseeing staff and trial procedures.

staff development, manage trial logistics, and contribute to strategic growth initiatives for future leadership opportunities.

What you will do:

As the Clinical Trial Operations Director, your duties and responsibilities will include:

and coordinate clinical trials across multiple Contract Research Organizations (CROs), ensuring adherence to protocols, regulatory standards, and commercial objectives.

a team of nurses and other direct reports to ensure smooth clinical operations, project execution, and alignment with commercial goals.

cross-functional reporting across regulatory, clinical, medical, and non-technical departments to ensure comprehensive oversight and compliance.

consistent communication with regulatory bodies like the FDA, ensuring adherence to Good Clinical Practice (GCP) and other regulatory principles.

multiple Institutional Review Board (IRB) contacts and clinical site protocols to ensure efficient trial organization and execution.

the development of trial protocols and informed consent forms, emphasizing patient interaction and bedside manner.

responsibility for clinical trial applications, inventory management, and legal matters related to contracts and invoicing with minimal supervision.

internal coordination of clinical trials, including administrative and back-office operations, while prioritizing commercial outcomes.

the training and development of clinical staff, ensuring alignment with commercial strategies and operational excellence.

growth opportunities, including potential client account ownership and regional business development, demonstrating the ability to scale operations and contribute to strategic planning as part of the leadership team.

What you will bring:

These are the skills and experience you will need to succeed as the Clinical Trial Operations Director:

leader with a successful track record in medical device clinical trial management, possessing in-depth regulatory knowledge.

at navigating complex challenges, leading teams, and driving clinical innovation with a strong commercial and patient-centered approach.

experience managing clinical trials across pharma, biotech, and med tech sectors, aligning clinical strategies with commercial goals.

ability to manage complex projects and stakeholders in a high-stakes, commercially-driven environment.

background in nursing or a related medical field, with hands-on experience in patient care and clinical oversight.

ability to independently manage all aspects of clinical trial execution from protocol development to final reporting, focusing on commercial success.

communication skills for high-level regulatory interactions and cross-functional team leadership.

in risk management, quality assurance, and process optimization with a commercial mindset.

and accountable, capable of adapting quickly to changing priorities while maintaining high standards under pressure.

experience in the cardiovascular therapeutic area.

What you will get:

These are the perks and benefits that will complement your generous base salary:

salary with healthcare, dental, and potential equity options.

compensation package reflects the demanding nature of the role and includes comprehensive benefits.

Got what it takes?

To apply for the Clinical Trial Operations Director, click the ‘Apply’ button below or contact the Executive Search Consultant – Georgia Harding – on +44 (.

Please Note:

job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorised to give instructions or assignments.

you have not heard from an Executive Search Consultant within ten working days from the date of your application, please consider yourself unsuccessful on this occasion.

use the information in your application to support your job search, contact you with relevant opportunities and to improve our services. For more information on how we process your personal data, please view our Privacy Policy available on our website:

Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry. Passionate about people, we take pride in helping exceptional life science organisations source the talent they need to design, manufacture and distribute life-changing drugs, treatments and devices which transform and save patient lives.

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