Senior Manager, Clinical 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 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 a committed, skilled, and customer-focused individual to join our winning team as a Senior Manager, Clinical 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.

Key Accountabilities :

Operational Management

• Provide a leadership role in the day-to-day operations of the Clinical Safety Monitoring functional area. This leadership role will involve hands-on planning, leading, assessing, performing, tracking, and delivery of projects, and monitoring the day-to-day operations, to ensure goals and objectives are met, policies and procedures are being followed, and services are provided effectively and efficiently.
• Contribute to the up-keeping of the positive, professional, high-performing, and productive work environment.
• Mentor the project team members for the responsible projects and monitor compliance and adherence to the established standards.
• Provide initial orientation training to new staff members in the functional area. Perform semi-annual and annual performance review and development plans for direct subordinates.
• Lead and grow the DMC / DSMB administration service area, overseeing staff development for the following main tasks : Identification, recruitment, and engagement of DMC / DSMB members, including contract negotiations, consultant agreements, and administration of honorarium payments.

DMC / DSMB Charter development.Planning, scheduling, and coordinating all DMC / DSMB meetings.

• May perform hands-on work for DMC / DSMB administration projects as needed and according to Everest’s data and safety monitoring Standard Operating Procedures.
• Set and achieve annual departmental goals and objectives.
• Participate in the recruitment of new functional group staff, through review of potential new candidates and participating in the interview process.

Business Development

• Assist with new business development, including generation of cost estimates and Requests for Proposal responses.
• Interact with clients with a focus on client relationship management and quality deliverables, ensuring their needs and requirements are met.
• Develop and review project budgets and timelines with ongoing regular reviews to assess progress and profitability.
• Perform business analysis and benchmarking in the business area; find room for continuous improvement.
• Participate in the development and maintenance of standards for DMC administration through participation in the development of related SOPs, guidelines, and good working practices.
• Serve on the management team ensuring departmental needs and concerns are represented.
• Ensure compliance with, and keep current, on all applicable regulations for DMC administration activities, and on Everest Guidance Documents.

Qualifications :

• Doctor of Philosophy degree in Clinical or Medical or Life Sciences, or Master’s degree with substantial experience in the subject matter.
• At least 10 years’ experience in safety monitoring in clinical trials, with an emphasis on DMC / DSMB / SRC / CEC administration.
• Experience leading a team with exceptional people management skills in dealing with the various functional areas within the company.
• Strong verbal and written communication skills with a demonstrated ability to understand and summarize medical terminology.
• Knowledge of DMC / DSMB regulations and industry standards and experience with the administration and management of DMCs / DSMBs / SRCs / CECs.
• Excellent understanding of clinical trials and experience in multiple therapeutic areas and Phase I through IV clinical trials an asset.
• Ability to handle multiple projects and clients; experience with client relationship management.
• Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging / conflicting deadlines.
• Ability to maintain a high degree of confidentiality with clinical data and client’s proprietary data.
• Detail-oriented, customer- and quality-focused.
Il y a 28 jours