Scientific Project Manager

Altasciences•Laval, QC

About The Position

The Scientific Project Manager leads project teams, manages relationships with internal and external stakeholders, supports logistics, and drives timelines and communication to ensure successful project execution. The role develops and proactively manages project timelines, oversees the scope of work including third-party vendor involvement, evaluates risks and implements mitigation plans, and manages project budgets toward expected profitability. Depending on project type, the position independently manages clinical projects from award through archival, oversees packages of nonclinical studies from award through completion, or executes CDMO projects from award through archival. The role also coordinates project documentation, regulatory and quality compliance, vendors, client communications, and project resources.

Requirements

Bachelor's degree or higher in Pharmacy, Pharmacology, Medicine, or Sciences; equivalent fields or experience may be considered.
At least 4 years of CDMO, clinical, or nonclinical research experience.
At least 2 years of related project management experience.
Ability to travel for client visits, site visits, and/or meetings, approximately 10%.
Fluency in English.
Proficiency with Microsoft Office, Client Relationship Management Systems, Electronic Case Report Forms, Electronic Trial Master Files, and Timeline Management Software.

Responsibilities

Coordinate the handoff from the pre-award team, including sharing relevant documents, timelines, and awarded scope.
Plan and execute internal and external project team meetings; document, circulate, and follow up on action items.
Review awarded scope, identify operational challenges, and suggest solutions with management support and guidance.
Prepare and host kickoff meetings with internal study teams and client representatives.
Maintain client expectations and requirements and ensure they are accessible company-wide in Ask Albert.
Manage third-party vendors as needed, including contracting, milestones, and billing or invoicing.
Assess out-of-scope activities for potential change orders.
Ensure critical milestones are met.
Ensure required documents, including CDAs and contracts, are in place before project conduct.
Work with Quality Assurance to maintain GxP and regulatory compliance.
Facilitate Lessons Learned meetings.
Participate in client visits or host clients as required.
Assist Business Development in promoting Altasciences' services.
For clinical projects, independently execute projects from study award through archival and manage project-specific timelines and critical paths.
Serve as the central point of contact for internal and external inquiries during clinical project execution and maintain effective communication.
Coordinate responses to situations that may affect project outcomes and escalate as appropriate.
Coordinate, review, and approve project documents, including protocols, informed consents, study manuals and plans, and case report forms.
Create and maintain Trial Master Files and ensure inspection readiness.
Support submissions to institutional review boards and regulatory agencies.
Facilitate identification, selection, initiation, monitoring, and closeout of appropriate investigational sites.
Contribute to protocol development relating to operational logistics.
Conduct budget reconciliations and provide project accruals.
For nonclinical projects, oversee packages of nonclinical studies, including Support Services, from award through completion.
Manage and track resources required throughout nonclinical study packages and contribute to contingency planning for key resources and activities.
Develop and maintain project tools such as summary reports, Gantt charts, financial trackers, communication plans, risk logs, and action trackers, and provide regular updates to stakeholders.
Assist in leading core teams, including Study Directors, Principal Investigators, and third-party vendors.
For CDMO projects, independently execute projects from study award through archival, manage timelines and critical paths, and identify, assess, and write change controls or quotations for out-of-scope activities.