Clinical Project Coordinator

Everest Clinical Research ( Everest ) is a full-service, global, 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, including clinical operations.

Everest’s headquarters are located in Markham Ontario, Canada with additional locations in : Bridgewater, New Jersey; Shanghai, China;

Taipei, Taiwan; and multiple offices in 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 a committed, skilled, and customer-focused individual to join our winning team as a Project Coordinator for our Toronto / Markham, Ontario, Canada on-site location.

Key Accountabilities :

• Act as a supporting team member within the Project Management Team and assist project management activities for assigned Phase I to IV clinical trials and in accordance with ICH guidelines, FDA, Health Canada, EMA, and other applicable regulatory and legal requirements.
• Support effective and efficient coordination of projects and tasks across the entire clinical trial and project / portfolio management lifecycle in the following areas : Business developmentProject start-upProject maintenance and deliveryProject closure and archival
• Perform project initiation administration tasks (e.g., set-up file folder / project folders, documentation and training maintenance, invoicing templates, etc.).
• Set-up and coordinate work plans and delivery timelines, Project Management Plans, Communication Plans, and other project start-up documentation.
• Draft Work Orders and Change Orders to maintain contractual alignment of studies.
• Support Project Management Leads in the planning, implementation, conduct, management, tracking and reporting of assigned projects within the established timelines and budgets, as well as with the quality required by Everest and general industry regulatory standards.
• Assist in the tracking of project deliverables to ensure quality and timeliness of all project-related tasks and actively manage project risks, actions, issues, and decisions (RAID).

Maintain accurate and current details for communication to internal and potentially external stakeholders.

Schedule project meetings (internal and external), as well as facilitate and communicate assignments, priorities, and expectations to the cross-functional project delivery teams.

Draft meeting agendas and minutes, ensuring support and approval of key stakeholders.

Assist in the coordination of activities between Everest and trial Sponsors, as well as various supporting groups or third-party vendors if applicable (e.

g., central laboratories and other specialty laboratories) to ensure that all contractual obligations are met and that any interdependent activities are coordinated effectively, and timelines planned for accordingly.

• Facilitate ad hoc requests to coordinate and follow-up on critical path tasks.
• Support timely and accurate maintenance of study information in a variety of systems and documents, such as the training matrix / tracker and work management tools.
• Perform invoicing, billing, and general financial management and analysis of projects, supporting healthy project financial performance.

Maintain up-to-date financial Work Order and billing tracking.

Support compliance of all documentation required for the Project Management team to support audit readiness and compliance;

this includes, but is not limited to the following : creation and maintenance of study-specific training documentation, training matrices, and trackers.

Support training follow-up across functional leaders to ensure project-specific training compliance, as well as support training compliance administration.

Under the guidance of project leadership, ensure successful project team mobilization and communication throughout the project lifespan.

Ensure and proactively track project milestones, deliverables, and overall success. This includes, but is not limited to, the following : Assist in project kick-off meetings (internal and external, as applicable), coordinating and tracking the dissemination of key project assumptions and information to relevant stakeholders.

Attend internal and external meetings and liaise with both internal and external stakeholders in ensuring well-prepared, efficient, and well-run meetings.

Assist in the implementation and updating of project management tools required to ensure accurate tracking and transparency around project progress, expectations, and stakeholders.

This may include updating project communication plans, RAID templates; mitigation strategies; statistics and programming tracking sheets;

etc.Assist the Project Manager Lead in integrating information to develop project budgets for each in-scope service and assisting in the development and maintenance of cross-functional project work plans, including identification of resource requirements, utilization, and deliverable timelines.

Track and manage project tasks against timelines and hours spent / budgets. Assist in the preparation of project status and progress reports.

Assist in the tracking and management of financial status against Work Order budgets, hours spent, tasks performed, and help reconcile expenses across sub-stream activities (e.

g., project attrition reports).

Support general operational and capability building activities for the Project Management department, such as : Assist in the preparation and / or revision of training materials, SOPs, new technology implementations, and drafting of templates and Working Instructions to develop standardization and streamlined approaches within the Project Management functional group.

Support compliance review of project management documentation across projects / clients.Work with project leadership to coordinate the establishment and maintenance of project information repositories to support Everest business analytics.

Under the guidance of business operations management and / or project leadership, support new business proposal development tasks as assigned by the proposal leader, including but not limited to, the following : Support organization and coordination of responding to and preparing for Request for Information and Request for Proposals across different functional groups.

Prepare proposal main and supporting documents, by updating proposal templates to project specific specifications, engaging respective functional group leaders, and compiling key information and project assumptions to ensure quality and accuracy of proposal content.

Support bid defense preparation, including materials development (e.g., drafting presentation slides), where required with guidance and training from the proposal leader.

Support contract development for newly engaged projects, including Service Work Orders, Change Orders, and any other project-specific contracts.

Qualifications and Experience :

• Bachelor of Science or Master of Science in life sciences or health related field.
• Experience in the delivery of clinical trials is typically a requirement, however, a willing, eager, and quality focused individual may learn and develop successfully.
• Two (2) years of clinical research experience within a pharmaceutical, biotechnology, or Contract Research Organization setting is preferred.
• Exposure to and demonstrated understanding of cross-functional processes including clinical operations, statistics, data management, subject randomization and drug supply management, data monitoring and adjudication committees, regulatory affairs, and medical writing.
• Knowledge and understanding of ICH guidelines, FDA, Health Canada, and EMA regulations.
• Ability to assist in developing general project management deliverables, including project plans, project scope, drafting budgets, project management trackers, agendas, and meeting minutes.
• Ability and experience in working with numbers and simple business quantitative calculations to support budget generation, reviews and checking, and project performance analysis.
• Demonstrated confidence and flexibility, with ability to adjust to multiple demands and shifting priorities.
• Excellent interpersonal, oral, and written communication skills.
• Detail-oriented individual, with the ability to accurately and professionally present all deliverables to the highest quality.
• Strong ability for critical thinking and quantitative (business) skills.
Il y a 17 jours