Senior Manager, Clinical Operations

Everest Clinical Research•Bridgewater, NJ

2d•Hybrid

About The Position

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 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 committed, skilled, and customer-focused individuals to join our winning team as a Senior Manager, Clinical Operations for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA or Canada in accordance with our Work from Home policy.

Requirements

At least a bachelor’s degree in science, health studies, research fields, or equivalent
At least 9 years of clinical research experience
Experience as a CRA and Clinical Lead (e.g. CTM)
Clinical Operations management experience, ideally in a CRO environment
Proven experience in leading a team 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

Responsibilities

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 department 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 Clinical Operations and identify opportunities for continuous improvement.
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.
Provide Clinical Operations oversight on selected projects, as needed.
Contribute to the development of client signed Work Orders and Change Orders, as needed.
Perform resource planning for the responsible business areas, 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 study proposals and bid defense meetings, as needed.
Plan and carry out professional development.