Manager, Clinical Data and Safety Monitoring

Manager, Clinical Data and Safety Monitoring
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 Corporate headquarters are located in Ontario, Canada and US headquarters in New Jersey, USA, with additional physical offices in Asia and 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  Manager, Clinical Data and Safety Monitoring  for our Toronto/Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy.

Accountabilities

Provide a leadership role in clinical data and safety monitoring in the day-to-day operations of the DMC/DSMB administration functional area, with focuses on planning and execution of DMC/DSMB administration and project management tasks and deliverables. This leadership role will involve hands-on planning, leading, performing, tracking, and delivery of assigned projects, and collaboration/interaction with DMC/DSMB biostatistical leadership, to ensure goals and objectives are met, policies and procedures are being followed, and service is provided effectively and efficiently.

Mentor project team members for the responsible projects and monitor compliance and adherence to the established standards.

Recruit, train, motivate, and develop staff to assure high levels of performance with strong professional and technical expertise. Complete annual and semi-annual performance reviews. Plan, implement, and oversee staff training and development process.

May perform as a DMC Administrator, driving effective and efficient management of DMC/DSMB administration projects with activities focused on planning and execution of DMC/DSMB administration tasks and biostatistical support for these committees. Administrative and project management tasks include hands-on work or supervision of others in the following areas:
Identify, recruit, and engage committee members, including contract negotiations, consultant agreements, and administration of honorarium payments.

Serve as the liaison between the committee and the sponsor.

Write or coordinate the writing of the committee Charter and its amendments and their review, finalization, and sign-off by the committee and Sponsor.

Coordinate the preparation of the committee Data Reports by external or internal statistical programming teams and the delivery of the Data Reports and other deliverables to the committee members, according to the Charter, including the preparation of project timelines as needed.

Plan, schedule, and coordinate all committee meetings, according to the Charter. When serving as the DMC/DSMB Secretary, produce meeting minutes, and assist the DMC/DSMB Chair with the Recommendation Letter,…