Senior Clinical Project Manager

This is a fully remote position, open to applicants in Canada.

📋 Description

• Taking a leadership position in guiding the efforts of functional area directors and managers during project planning, task and deliverable identification, resource needs assessment and utilization, as well as risk identification and mitigation.

• Ensures that current projects have established project plans in accordance with the defined Standard Operating Procedures (SOPs).

• Monitors and reports on project progress status, ensuring that issues are swiftly identified and addressed.

• Collaborates with functional area directors and managers to jointly ensure seamless project initiation, ongoing execution, and successful completion.

• Engages with clients to forecast resource requirements and for project management objectives.

• Responsible for defining project scope, estimating budgets, planning, directing, leading project activities, managing resources and budgets, and overseeing project team performance of cross-functional teams involved in clinical research and development activities.

• Accountable for updating Everest internal management and clients regarding project progress status.

• May assist the organization in responding to and preparing Requests for Information (RFI) and Requests for Proposals (RFP), as well as in defining scope of work and budgets, and carrying out contract administration activities.

⛳️ Requirements

• Bachelor of Science (B.Sc.) or M.Sc., or equivalent, in life sciences or a health-related field.

• More than 10 years of experience in clinical research and development within a pharmaceutical, biotechnology, or Clinical Research Organization (CRO) environment.

• At least 7 years of experience in the clinical pharmaceutical industry, demonstrating skills and competency in clinical project management tasks.

• Oncology experience is strongly preferred.

• Familiarity with the clinical research process, including Phase I trials through to regulatory submission.

• Previous experience as a clinical trial monitor with a background in initiating, monitoring, and closing out clinical trials is advantageous.

• Knowledge and understanding of ICH guidelines, FDA, Health Canada, and EMA regulations.

• Proven understanding of cross-functional processes such as site selection, study start-up clinical operations, statistics and statistical programming, data management, subject randomization and drug supply management (IWRS), data monitoring and/or adjudication committees, regulatory submissions, vendor management, and medical/scientific writing.

• Demonstrated leadership skills, including the ability to set objectives for others and drive achievement in alignment with allocated resources, timelines, and budgets.

• Strong financial acumen, capable of defining project scope and estimating budgets, as well as planning and managing projects, including resource requirements and utilization, hours compared to budgets, key deliverables, and timelines.

• Exceptional interpersonal, oral, and written communication skills.

• Strong negotiation and presentation abilities.

• Excellent problem-solving capabilities, including conflict resolution skills.

🏝️ Benefits

• Medical, dental, and vision coverage.

• Life & AD&D insurance.

• Short- and long-term disability.

• Tuition reimbursement.

• Fitness reimbursement.

• Employee assistance program (EAP).

• 401(k) retirement plan.

• Generous paid time off.

• Sick leave.

• Opportunity to earn a performance-based bonus.