Project Manager, Data Monitoring Committees for our Toronto/Markham, Ontario, Canada Location
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 Little Falls (Greater New York City Area), New Jersey, USA, and Shanghai (Pudong Zhangjiang New District), China. 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 a seeking committed, skilled, and customer-focused individual to join our winning team as Project Manager, Data Monitoring Committees for our Toronto/Markham, Ontario, Canada location.
The Project Manager, Data Monitoring Committees is responsible for project management and administrative tasks for data monitoring committees (DMCs; also referred to as Data and Safety Monitoring Boards [DSMBs], Safety Monitoring Committees [SMC], etc.) and adjudication committees. This individual will manage the operational execution of multiple expert committees and support DMC administration teams, with focuses on planning and execution of DMC administrative and related project management tasks.
- Manage DMC projects with activities focused on planning and execution of DMC administration tasks and biostatistical support for these committees. This role will involve planning, leading, assessing, reporting, and tracking the progress status of the assigned projects, and monitoring the day-to-day operations of assigned projects to ensure goals and objectives are met, policies and procedures are being followed, and service is provided effectively and efficiently.
- Manage the planning, implementation, conduct, and reporting of assigned projects within the established timelines and budgets, with high quality and meeting regulatory requirements.
- Coordinate activities between Everest and trial sponsors, and with various supporting groups or vendors when necessary.
- Perform invoicing and tracking for DMC projects.
- Proactively track and manage project tasks against timelines and hours spent/budgets; alert management when there are risks of having major deviations.
- Perform hands on administrative tasks for assigned committees, according to Everest’s SOPs. These tasks include, but are not limited to, the following:
- Assist with the identification, recruitment, and engagement of 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, produce meeting minutes, and assist the DMC Chair with the Recommendations Letter, according to the Charter.
- When required, assist the organization in responding to and preparing for Request for Information and Request for Proposals, and subsequently defining work scopes and budgets, and performing contract administration activities.
- Monitor and report on project progress for all DMC administration projects. Proactively identify and report issues or factors that potentially will impact the quality and timeliness of the projects.
- Conduct “lessons learned” meetings with project team members to learn from failures and prevent these in future projects.
- Work closely with the Everest project team members and interact with sponsor staff assigned to the project to achieve project milestones according to the project timeline, following up on sponsor requests/requirements, and reviewing any obstacles/difficulties or deviations from the project requirements for the DMC administration/management projects.
- Ensure compliance with, and keep current on, all applicable regulations for DMC activities and on Everest Guidance Documents. Participate in writing/updating Governing Documents for the functional area.
- Plan and carry out professional development.
Qualifications and Experience:
- M.Sc. or Ph.D. in a clinical or medical or health related field
- Minimum of 5 years’ clinical research experience within a pharmaceutical, biotechnology, or CRO setting.
- Minimum of 3 years’ experience in project management and 2 years’ experience with administration and management of data monitoring committees.
- Knowledge of DMC regulations and industry standards.
- Ability to define scopes and estimate budgets, plan and manage projects, including resource requirements and utilization, hours spent vs. budgets, key deliverables and timelines.
- Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments.
- Strong verbal and written communication skills. Demonstrated strong negotiation and presentation skills.
- Experience with client relationship management is an asset.
- Excellent interpersonal and teamwork skills.
- Ability to maintain a high degree of confidentiality with clinical data and client’s proprietary data.
- Detail-oriented, customer- and quality-focused.
- Excellent proficiency with Microsoft Office Suite.
How to Apply:
Please send your application along with cover letter to [email protected].
To find out more about Everest Clinical Research and to review other opportunities, please visit our WEB site at www.ecrscorp.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.