04 Sep
|
Everest
|
Winnipeg
Job OverviewThe Senior Project Manager position is responsible for taking a leadership role in facilitating the efforts of functional area directors and managers in project planning, identification of tasks and deliverables, assessment of resource needs and utilization, and risk identification/mitigation. The role performs overall company-wide project progress tracking using strategic planning and project tracking methods and tools, ensuring that ongoing projects under their scope have existing project plans as required by the established Standard Operating Procedures (SOPs) and that project progress status is properly tracked, reported, and issues are promptly identified and resolved.Key Job AccountabilitiesAssure the fulsome and accurate transfer of contracts from initial project proposal to mobilization through to completion and end-to-end financial reconciliation.Manage projects from initiation through closure for full scope regional and global projects, focusing on site selection, study start-up, clinical operations, statistics and programming, data management, subject randomization and drug supply management (IWRS), data monitoring, regulatory submissions, vendor management, and medical/scientific writing.Facilitate the efforts of functional area directors and managers in project planning, identification of tasks and deliverables, and assessment of resource needs and utilization.Perform project progress tracking for responsible projects using planning methods, tools, and software, providing monthly project progress status reports for individual ongoing projects.Check and ensure that responsible projects have a properly tracked and periodically reported project plan, as required by the SOPs and Working Instructions.Prepare project status reports and maintain accurate and current details; present project status to internal and external stakeholders, inclusive of comprehensive risk identification and sound mitigations.Conduct responsible project progress status meetings with individual project teams, focusing on projects that require close follow-up or immediate action.Identify issues such as lack of planning, lack of resources, or poor team performance through review meetings and bring them to the attention of the functional area directors and managers.Act as a meeting facilitator for meetings involving various internal and external participants.Lead project management interfacing with clients to drive project delivery, communication, problem solving, and issue management; convey scope and resource requirements,
financial and contracting statuses, and seek sponsor approval for scope changes and project decisions when appropriate.Ensure that contracted scope of work is clear, track and initiate development of out-of-scope work or change orders with clients, and coordinate activities between Everest and trial sponsors and supporting vendors.Lead cross-functional project teams, manage planning, implementation, conduct, and reporting of assigned projects within the established timelines and budgets, and with quality and regulatory requirements.Proactively track and manage project tasks against timelines and budgets, alerting management when there are significant deviations.Function as a facilitator of problem solving, lessons learned, and conflict resolution, sharing information with leadership where appropriate to improve future project deployment.Proactively track and manage the financial status against budget and reconcile expenses across sub-streams, meeting financial performance targets for assigned clinical projects.Integrate information to define scope of work and estimate budgets; develop and manage cross-functional project work plans, including resource requirements, utilization, budgets, quality deliverables, and timelines.Manage all project management aspects of assigned Phase I to IV clinical trials in accordance with ICH guidelines, FDA, Health Canada, EMA, and other applicable regulatory requirements.Communicate project action items and key decisions through timely minutes and follow-up documentation.Review and contribute to the development of policies and SOPs in project management and assurance of quality deliverables in consultation with the Senior Project Management Leadership Team.Contribute and/or participate in the performance evaluation of staff who performed under the responsible projects.Assist the organization in responding to and preparing for RFI and RFP, defining scope of work and budgets, and performing contract administration activities when required.Perform clinical trial planning, management,
and site oversight from initiation to closure when needed.Generate new sales leads by developing trust-based relationships with client counterparts to secure repeat and new business based on existing client relationships.Be available to travel up to 20%, including international travel.Qualifications and ExperienceBachelor of Science (B.Sc.) or Master of Science (M.Sc.) in life sciences or a related health field.Over 10 years’ experience in clinical research and development within a pharmaceutical, biotechnology, or CRO setting, including a minimum of 7 years in clinical pharmaceutical industry experience with proven clinical project management skills.Oncology experience is highly preferred.Alternatively, candidates with more than 5 years of supervisory experience in a healthcare setting and 6 years of clinical research experience in the pharmaceutical or CRO industries will be considered; clinical researchsite experience is a plus.Knowledge of the clinical research process from Phase I trials through regulatory submission.Experience as a clinical trial monitor, initiating, monitoring, and closing out trials, is desirable.Understanding of ICH guidelines, FDA, Health Canada, and EMA regulations.Experience with cross‑functional processes such as site selection, study start‑up, clinical operations, statistics, data management, IWRS, data monitoring, regulatory submissions, vendor management, and medical/scientific writing.Demonstrated leadership abilities, including setting goals for others and driving achievement within allocated resources, timelines, and budgets.Solid financial acumen, including scope definition, budget estimation, and tracking of hours versus budgets; ability to identify out‑of‑scope work and initiate change orders.Excellent interpersonal, oral, and written communication skills, with strong negotiation and presentation skills.Strong problem‑solving and conflict resolution capabilities.Benefits & CompensationWe offer a robust perks package, including medical, dental, and vision coverage; life, AD&D; insurance; short‑ and long‑term disability; tuition and fitness reimbursement; employee assistance program; a 401(k) retirement plan; generous paid time off and sick leave; and a performance‑basedbonus. Estimated salary range: $125,000 – $175,000.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.#J-18808-Ljbffr
📌 Senior Clinical Project Manager (Markham) - $125,000 - $175,000 A Year (Winnipeg)
🏢 Everest
📍 Winnipeg