Manager, Clinical Operations

Everest Clinical Research (“Everest”) is a full-service 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. Everest’s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan.

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 committed, skilled, and customer-focused individuals to join our winning team as a Manager, 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 Manager, Clinical Operations is responsible for working with the Associate Director, Director, or Senior Director of Clinical Operations and the Clinical Operations teams to ensure quality and timely delivery of clinical operations deliverables, actively and proactively leading projects and interacting with clients, build and maintain strong client relationships and mutually beneficial long-term partnerships with the clients. **

Job Accountabilities**

• Actively participate and contribute to the Everest management team activities/function, including but not limited to, the following:
  • Plan, hire, train, and mentor Clinical Operations personnel. Perform staff performance management and career developmental planning.
  • Perform strategic planning and carry out plans for the continued development and improvement of overall Everest performance.
  • Discuss and contribute to setting annual corporate level goals/objectives; enable or contribute to the achievement of these goals/objectives.
  • Contribute to the up-keep of the positive, professional, high performing, and productive work environment.
  • Monitor and ensure compliance/adherence to corporate governing documents (policies, Standard Operating Procedures (SOPs), Work Instructions).
  • Continue to build client relationships and grow the Everest brand.
  • Perform business analysis and benchmarking in each business area and identify opportunities for continuous improvement.
• Managers responsible for Clinical Research Associate (CRA) direct reports/oversight may:
  • Provide resourcing, oversight, study assignment, training, and metrics reviews for CRA(s).
  • Perform oversight/accompanied site visits to assess CRA performance and mentor/train, if needed.
  • Assist in review of Monitoring Visit Reports.
• Oversee internal Clinical Operations within the job-scope to deliver quality and timely deliverables to clients; manage 1-2 client accounts and perform client relationship management, if needed.
• Contribute to the development of client signed Work Orders and Change Orders, as needed.
• Perform budget and resource planning for the responsible business areas, as needed.
• Develop working relationships with potential Investigators, investigational sites, key opinion leaders in various therapeutic areas, and vendors needed to support clinical trials, as needed.
• Author and review Clinical Operations governing documents, as needed.
• Prepare for and actively participate in internal and external quality assurance audits for Everest Clinical Operations.
• Assist with preparation of materials for Requests for Proposal and bid defense meetings, as needed.
• May lead Clinical Operations projects during start-up periods and assist with site management/monitoring related tasks.
• Plan and carry out professional development.

Qualifications

• Must have at least a bachelor or master’s degree in science, health studies and research fields, or equivalent with 12 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.
• 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.
• Travel level specification: this position may require 20% to 50% business travel.