Senior Project Manager I

Senior Project Manager I

Everest Clinical Research, a leading full-service contract research organization (CRO), is seeking a highly skilled and motivated Senior Project Manager I to join our Brightech team. We specialize in providing expert biostatistics, programming, and clinical data management services to the pharmaceutical, biotechnology, and medical device industries worldwide. As a critical partner to some of the world's largest companies, we work with cutting-edge drugs, biologics, and medical devices.

This is a permanent, remote position.

About the Role

The Senior Project Manager I will be responsible for the end-to-end management of clinical research projects, from initial proposal and mobilization through to project completion and financial reconciliation. You will lead cross-functional teams, ensuring projects are delivered on time, within budget, and to the highest quality standards, meeting all regulatory requirements.

Key Responsibilities

• Oversee the complete project lifecycle, including site selection, study start-up, clinical operations, biostatistics, data management, regulatory submissions, and vendor management.
• Ensure accurate transfer of contracts from proposal to project completion and financial reconciliation.
• Facilitate project planning, task identification, and resource assessment with functional area directors and managers.
• Track project progress using planning and tracking tools, providing regular status reports to internal and external stakeholders.
• Identify and mitigate project risks, proactively addressing issues impacting project timelines, resources, or performance.
• Serve as the primary client interface, managing communication, problem-solving, and issue resolution.
• Manage scope changes and initiate change orders for out-of-scope work.
• Coordinate activities between Everest, trial sponsors, and external vendors.
• Manage project budgets, track financial status, and reconcile expenses.
• Ensure compliance with ICH guidelines, FDA, Health Canada, EMA, and other applicable regulatory requirements.
• Contribute to the development of policies and Standard Operating Procedures (SOPs).
• Identify opportunities for new business and client account growth.

Requirements

• Bachelor of Science (B.Sc.) or Master of Science (M.Sc.), or equivalent, in life sciences or a health-related field.
• Over 10 years of experience in clinical research and development within a pharmaceutical, biotechnology, or CRO setting.
• Minimum of 7 years of clinical pharmaceutical industry experience with demonstrated skills in clinical project management.
• In lieu of the above, candidates with over 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.
• Knowledge of the clinical research process, including Phase I trials through regulatory submission.
• Understanding of ICH guidelines and relevant regulatory requirements (FDA, Health Canada, EMA).
• Demonstrated understanding of cross-functional processes within clinical trials.
• Proven leadership abilities, with experience in setting goals and driving team performance.
• Solid financial acumen, including budget estimation, management, and reconciliation.
• Excellent interpersonal, oral, and written communication skills, with strong negotiation and presentation abilities.
• Strong problem-solving and conflict resolution skills.
• Fluency in French, including medical and scientific terminology, is an asset.
• Availability to travel up to 20%, including international travel.