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:

1. 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.
2. Mentor project team members for the responsible projects and monitor compliance and adherence to the established standards.
3. 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.
4. 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, according to the Charter.
   • Coordinate activities between Everest and trial sponsors, and with various supporting groups or vendors when necessary.
   • Prepare for and facilitate DMC/DSMB project kick-off meetings (internal and external, as applicable), ensuring dissemination of key project assumptions and information to relevant stakeholders. Communicate project action items and key decisions through timely minutes and follow-up actions.
   • Perform invoicing and tracking for assigned DSMB/DMC projects. Proactively track and manage project tasks against timelines and hours spent/budgets. Prepare project status and progress reports, maintaining accurate and current details for communication to internal and potentially external stakeholders.
5. Function as leading facilitator of problem solving and conflict resolution, working with functional leaders to drive strategic and effective decisions and plans for DMC/DSMB administration projects.
6. Set and achieve annual departmental goals and objectives.
7. Monitor performance metrics, KPIs (Key Performance Indicators), and perform analysis of the metrics for DMC/DSMB administration activities.
8. Participate in the development and maintenance of standards for DMC/DSMB administration through participation in the development of related Policies, Standard Operating Procedures (SOPs), Working Instructions, guidelines, and good working practices.
9. Participate in and contribute to the departmental efforts in investigating, establishing, and implementing new and advanced reporting systems, tools, and reports to improve the effectiveness of the DMC/DSMB administration service offerings.
10. Interact with clients with a focus on client relationship management and quality deliverables.
11. Assist with new business development, including generation of cost estimates and Requests for Proposal responses, and preparation for and participation in bid defense meetings.
12. Perform business analysis and benchmarking in the business area; find room for continuous improvement.
13. Serve on the management team ensuring departmental needs and concerns are represented.
14. Plan and carry out professional development.
15. Ensure compliance with, and keep current, on all applicable regulations for DMC/DSMB administration and on Everest Guidance Documents.

Requirements:

1. Advanced degree, Ph.D. preferred, in Clinical or Medical or Life Sciences, or Master’s degree with substantial experience in the subject matter.
2. At least 8 years' experience with clinical trials in the academic, pharmaceutical, or CRO environment and at least 5 years’ experience in the administration of DMCs/DSMBs.
3. At least 3 years’ experience in managing people and/or projects.
4. Knowledge of DMC/DSMB regulations and industry standards, with demonstrated experience, knowledge, and understanding of GCP/ICH guidelines.
5. Ability to maintain a high degree of confidentiality with clinical data and client’s proprietary data
6. Experience in multiple therapeutic areas and Phase I through IV clinical trials an asset.
7. Excellent understanding of clinical trials and common clinical trial statistical analysis methods.
8. Strong verbal and written communication skills with a demonstrated ability to understand spoken and written medical information and results.
9. Good organizational skills with the ability to adapt and adjust to changing priorities and to handle multiple projects and clients.
10. Excellent interpersonal and teamwork skills; detail-oriented, customer- and quality-focused.
11. Proven flexibility and adaptability when working in a team and independently, using good judgment in making decisions, is preferred.
12. Comprehensive skills in MS Office applications and Adobe Acrobat. Computing skills with TRS Toolbox pharma edition plugin an asset.

Benefits & Compensation:

We offer a robust benefits package to support your health, well-being, and growth, including medical, dental, and vision coverage, life & AD&D insurance, short- and long-term disability, tuition reimbursement, fitness reimbursement, employee assistance program (EAP), a pension plan, generous paid time off and sick leave, and the opportunity to earn a performance based bonus.

Estimated Salary Range: $120,000 - $140,000.

To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.everestclinical.com.

We thank all interested applicants, however, only those selected for an interview will be contacted.

Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.

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