About The Role
The Scientific Project Manager leads project teams, manages key relationships with internal and external stakeholders, supports logistics, and drives timelines and communication to ensure successful execution. The Scientific Project Manager develops and proactively manages project timelines and is responsible for the scope of work including third party vendor involvement. The Scientific Project Manager adequately evaluates probability and impact of risk, develops and implements risk management plans to mitigate effect on project objectives and deliverables, and effectively navigates project budgets towards expected profitability.
What You'll Do Here
Liaise with pre-award team to facilitate an effective handoff, including sharing all documents, timelines and awarded scope
Plan and execute internal and external project team meetings, and ensure action items are documented, circulated, and completed
Review and evaluate awarded scope, identify any operational challenges, and suggest solutions with support and guidance from Management
Prepare and host kick off meetings with internal study teams and client representatives
Maintain client expectations and requirements, ensuring accessibility company-wide in Ask Albert.
Manage third party vendors as necessary, including overseeing contracting, milestones and billing/invoicing
Assess out of scope activities for potential change orders
Ensure critical milestones are met using autonomy and interpersonal skills
Ensure appropriate documents are in place prior to project conduct, including CDA's and contracts
Work with Quality Assurance to ensure GxP and regulatory compliance is maintained
Facilitate Lessons Learned meetings
Participate in client visits, or host clients, as required
Provide assistance to Business Development in promoting Altasciences' services
Clinical
Independently execute projects from study award through archival
Develop project-specific timelines and proactively manage the critical path to ensure on-time execution and delivery per scope of work
Act as the central point of contact for all internal and external stakeholder inquiries during execution of a project and maintain effective and efficient communication with all parties
Manage and coordinate, along with the project team, any situation impacting project outcomes and escalate as appropriate
Coordinate, review and approve project related documents including but not limited to protocols, informed consents, study manuals and plans, case report forms
Create and maintain Trial Master Files, and ensure inspection readiness
Support submissions to institutional review boards and regulatory agencies
Facilitate process of identification, selection, initiation, monitoring, and close out of appropriate investigational sites
Contribute to protocol development regarding operational logistics
Conduct budget reconciliations and provide project accruals
What You'll Need to Succeed
Bachelor or higher level degree in Pharmacy, Pharmacology, Medicine, Sciences. Equivalent fields or experience may be considered.
Minimum 4 years of CDMO, clinical or nonclinical research experience required, including a minimum of 2 years of related Project Management experience.
Ability to travel for client visits, site visits and/or meetings (approx. 10%)
Software: Microsoft Office, Client Relationship Management Systems, Electronic Case Report Forms, Electronic Trial Master Files, Timeline Management Software
Altasciences strives to provide a French working environment for its employees in Quebec. Although as part of its francization program has taken all reasonable steps to avoid imposing the above-mentioned requirement. Fluency in English is an essential requirement for the position of Scientific Project Manager including, but not limited to, for the following reasons:
The requirement to have study protocols, designs and clinical research documents written and documented in English as required by industry regulatory agencies.
The…