Senior Director, Clinical Operations
5 days ago
Everest Clinical Research (“Everest”) is a full-service, global, contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.
Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO, including clinical operations. Everest’s headquarters are located in Markham Ontario, Canada with additional locations in: Bridgewater, New Jersey; Shanghai, China; Taipei, Taiwan; and multiple offices in Europe.
Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.
Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest.
To drive continued success in this exciting clinical research field, we are seeking a committed, skilled, and customer-focused individual to join our winning team as a Senior Director, Clinical Operations for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA in accordance with our Work from Home policy.
The incumbent is responsible for leading, further developing, and expanding the clinical operations team to deliver a streamlined, effective, and client-centered approach to service. Oversee Clinical Operations Shared Services (i.e., hiring, training, resource allocation/utilization, performance management, audits, systems, client surveys, etc.) across clients to ensure operational excellence of department while contributing to company goals/objectives. Provide mentorship and guidance to Directors, Associate Directors, and Managers to maintain consistency and successful project delivery.
JOB ACCOUNTABILITIES:
Lead a Regional Clinical Operations function within Everest. This includes, but is not limited to, the following:
- Direct line management of Clinical Operations staff as various levels/areas of responsibility.
- Support the development of business proposals (Request for Information, Requests for Proposals, etc.) and participate in bid defense meetings.
- Review and enhance existing clinical operations governing documents.
- Plan, hire, train, and mentor Clinical Operations personnel. Perform staff performance management, periodic performance evaluation, and career developmental planning.
- Manage client accounts and perform client relationship management.
- Oversee client contracts and contract amendments.
- Oversee internal clinical operations to deliver quality and timely deliverables to clients.
- Perform budget and resource planning for the responsible business areas; control and report project level and departmental budget spend.
- Develop working relationships with potential Investigators, investigational sites, and key opinion leaders in various therapeutic areas, and vendors needed to support clinical trials.
- Prepare and participate in internal and external quality assurance audits on Everest Clinical Operations.
Actively participate and contribute to the Everest management team activities/function, including but not limited to, the following:
- Perform strategic planning and carry out plans for the continued development and improvement of overall Everest performance.
- Discuss and set annual corporate level goals/objectives; enable or contribute to the achievement of these goals/objectives.
- Contribute and maintain a positive, professional, high performing, and productive work environment.
- Ensure compliance/adherence to corporate governing documents (Policies, Standard Operating Procedures [SOPs], Work Instructions).
- Continue to build client relationships and grow Everest brand with them.
- Perform business analysis and benchmarking in each business area as well as at the corporate level, find room for continuous improvement.
QUALIFICATIONS:
- Must have a Bachelor of Science degree with 20 years of clinical research experience or a Master’s degree, MBA, or equivalent with 19 years of clinical research experience.
- Requires experience in business and operational management, broad-based business operations experience in clinical research environment, preferred in the Clinical Research Organization industry.
- At least 10 years’ experience in clinical operations with 7 years in a managerial capacity.
- Very good industry reputation with a wide customer base of contacts.
- Proven experience in leading an organization to optimum performance and contributions.
- Exceptional people management skills with ability to interact successfully and communicate effectively with personnel at all levels within the organization and with client contacts.
- Exceptional written communication and presentation skills.
- Moderate travel may be required, approximately 25%.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
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