Scientific Project Manager

Altasciences is hiring a Scientific Project Manager to lead clinical, nonclinical, or CDMO projects from award through completion or archival. The role manages project teams, stakeholder relationships, timelines, scope, risks, budgets, vendors, and communication to support successful project execution.

Responsibilities:

• 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
• 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
• Independently oversee packages of nonclinical studies (including Support Services) from award through completion
• Manage and track individual project resources needed throughout the study package
• Contribute to contingency planning for key resources and activities
• Understand Altasciences’ service lines and capabilities, to serve as a point of contact for internal and external stakeholder inquiries during execution of a nonclinical package
• Develop and maintain appropriate tools, such as summary report, Gantt, financial trackers, communication plan, risk log, action trackers, etc. for each study package, ensuring that regular updates are provided to internal and external stakeholders
• Assist in the leadership of the core team, including Study Directors, Principal Investigators, and third party vendors
• 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
• Identify, assess and write change controls or quotations for out of scope activities

Requirements:

• 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
• Software: Microsoft Office, Client Relationship Management Systems, Electronic Case Report Forms, Electronic Trial Master Files, Timeline Management Software
• Fluency in English is an essential requirement for the position of Scientific Project Manager