[Hiring] Manager, Clinical Data and Safety Monitoring @Everest Clinical Research

Role Description

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.

• Provide a leadership role in clinical data and safety monitoring in the day-to-day operations of the DMC/DSMB administration functional area.
• Focus on planning and execution of DMC/DSMB administration and project management tasks and deliverables.
• Mentor project team members for the responsible projects and monitor compliance and adherence to established standards.
• Recruit, train, motivate, and develop staff to assure high levels of performance with strong professional and technical expertise.
• May perform as a DMC Administrator, driving effective and efficient management of DMC/DSMB administration projects.
• Identify, recruit, and engage committee members, including contract negotiations 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.
• Coordinate the preparation of the committee Data Reports by external or internal statistical programming teams.
• Plan, schedule, and coordinate all committee meetings, producing meeting minutes when serving as the DMC/DSMB Secretary.
• Coordinate activities between Everest and trial sponsors, and with various supporting groups or vendors.
• Prepare for and facilitate DMC/DSMB project kick-off meetings.
• Perform invoicing and tracking for assigned DSMB/DMC projects.
• Function as leading facilitator of problem solving and conflict resolution.
• Set and achieve annual departmental goals and objectives.
• Monitor performance metrics, KPIs, and perform analysis of the metrics for DMC/DSMB administration activities.
• Participate in the development and maintenance of standards for DMC/DSMB administration.
• Interact with clients with a focus on client relationship management and quality deliverables.
• Assist with new business development, including generation of cost estimates and Requests for Proposal responses.
• Perform business analysis and benchmarking in the business area.
• Serve on the management team ensuring departmental needs and concerns are represented.
• Plan and carry out professional development.
• Ensure compliance with all applicable regulations for DMC/DSMB administration.

Qualifications

• Advanced degree, Ph.D. preferred, in Clinical or Medical or Life Sciences, or Master’s degree with substantial experience in the subject matter.
• At least 8 years' experience with clinical trials in the academic, pharmaceutical, or CRO environment.
• At least 5 years’ experience in the administration of DMCs/DSMBs.
• At least 3 years’ experience in managing people and/or projects.
• Knowledge of DMC/DSMB regulations and industry standards.
• Ability to maintain a high degree of confidentiality with clinical data and client’s proprietary data.
• Experience in multiple therapeutic areas and Phase I through IV clinical trials an asset.
• Excellent understanding of clinical trials and common clinical trial statistical analysis methods.
• Strong verbal and written communication skills.
• Good organizational skills with the ability to adapt to changing priorities.
• Excellent interpersonal and teamwork skills; detail-oriented, customer- and quality-focused.
• Proven flexibility and adaptability when working in a team and independently.
• Comprehensive skills in MS Office applications and Adobe Acrobat.

Requirements

• Advanced degree, Ph.D. preferred, in Clinical or Medical or Life Sciences, or Master’s degree with substantial experience in the subject matter.
• At least 8 years' experience with clinical trials in the academic, pharmaceutical, or CRO environment.
• At least 5 years’ experience in the administration of DMCs/DSMBs.
• At least 3 years’ experience in managing people and/or projects.
• Knowledge of DMC/DSMB regulations and industry standards.
• Ability to maintain a high degree of confidentiality with clinical data and client’s proprietary data.
• Experience in multiple therapeutic areas and Phase I through IV clinical trials an asset.
• Excellent understanding of clinical trials and common clinical trial statistical analysis methods.
• Strong verbal and written communication skills.
• Good organizational skills with the ability to adapt to changing priorities.
• Excellent interpersonal and teamwork skills; detail-oriented, customer- and quality-focused.
• Proven flexibility and adaptability when working in a team and independently.
• Comprehensive skills in MS Office applications and Adobe Acrobat.

Benefits

• Medical, dental, and vision coverage.
• Life & AD&D insurance.
• Short- and long-term disability.
• Tuition reimbursement.
• Fitness reimbursement.
• Employee assistance program (EAP).
• Pension plan.
• Generous paid time off and sick leave.
• Opportunity to earn a performance-based bonus.