Clinical Project Manager

3 days ago

Markham, Canada Everest Clinical Research Full time

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 seeking committed, skilled, and customer-focused individuals to join our winning team as a **Clinical Project Manager **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 Responsibilities**:
The incumbent is accountable for effective and efficient project and portfolio delivery from project start up through closure, ensuring all functional, technical, and financial aspects of the project are being managed effectively and against client and Everest expectations. The project/portfolio management duties include, but are not limited to, establishing the project/portfolio management and tracking foundation for an assigned client, establishing the overall client and service delivery strategy for a given project or group of projects, defining project scope and cost estimate budgets, planning, directing, and controlling project activities, managing resources and budgets, and optimizing the project team’s performance of cross-functional teams engaged in clinical research and development activities. This position is also accountable for reporting project progress status to Everest internal management and its clients, and regular project billing, invoicing, and financial tracking/reporting activities. These activities may include, but are not limited to, managing projects with activities focused on clinical operations/site start up and monitoring, clinical data management, statistics, medical writing, clinical trial technologies (including Interactive Web Response Systems [IWRS]/Interactive Response Technology [IRT] and eDiary/electronic Patient Reported Outcomes [ePRO] systems), administration of data monitoring and adjudication committees, and preparation of drug submissions to regulatory agencies.

When required, the incumbent may assist the organization in responding to and preparing for Request for Information (RFI) and Request for Proposals (RFP), analyzing the study protocol and project parameters, and subsequently developing cost estimate budgets and performing contract administration activities working with senior leaders in Project Management and Business Operations.

When required, the incumbent may also lead project management capability development activities, including the development or enhancement of Standard Operating Procedures (SOPs), project management software, project delivery and control process improvement, and training initiatives.
- Drive effective and efficient management of projects with activities focused on one or more of Everest service areas/functional groups: clinical operations, data management, statistics, medical writing, clinical trial technologies (IWRS/IRT and eDiary/ePRO), administration of data monitoring and adjudication committees, and preparation of submissions to regulatory agencies.
- With the guidance of project leadership, ensure successful project team mobilization and communication throughout a project’s lifespan to ensure and proactively track project milestones, deliverables, and overall success. This includes, but is not limited to, the following:

- Integrate information to develop project budgets for each in-scope service and develop and maintain cross-functional project work plans, including identification of resource requirements and utilization, and deliverable timelines.
- Prepare for and facilitate project kick-off meetings (internal and external, as applicable), ensuring dissemination of key project assumptions and information to relevant stakeholders.
- Implement project management tools required to ensure accurate tracking and transparency around project progress, expectations, and stakeholders. This may include project communication plans, risk mitigation strategies, statistics and programming tracking sheets, and etc.
- Lead all project management aspects of assigned Phase I-IV clinical trials and in accordance with ICH guidelines, FDA, Health Canada, European Medicines Agency (EMA), and other applicable regulatory and legal

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