Scientific Project Manager

Altasciences; United States; Remote; USD 90.000 - 140.000; Vollzeit

Benefits dieser Stelle

Health insurance

RRSP with employer match

Paid vacation

Sick leave and bereavement

Telehealth programs

Zusammenfassung

Altasciences seeks a Scientific Project Manager in the United States to lead cross-functional project teams, manage client and internal stakeholder expectations, and drive timelines and budgets for CDMO programs.

You will facilitate pre-award handoffs, coordinate with vendors, manage risk, and ensure regulatory and quality compliance across clinical and nonclinical studies. Travel up to ~10% is required.

Qualifikationen

• Bachelor or higher in Pharmacy, Pharmacology, Medicine, or Sciences.
• Minimum 4 years of CDMO, clinical or nonclinical research experience, including 2 years in Project Management.
• Willingness to travel ~10% for client/site visits.
• Software: Microsoft Office, CRM Systems, electronic trial master files and related tools.

Aufgaben

• Lead project teams and manage relationships with internal and external stakeholders.
• Plan and execute internal and external project team meetings, documenting and circulating action items.

Kenntnisse

Project management

Stakeholder management

Risk management

Timeline management

Ausbildung

Bachelor or higher in Pharmacy, Pharmacology, Medicine, or Sciences

Tools

Microsoft Office

Client Relationship Management Systems

Electronic Case Report Forms

Electronic Trial Master Files

Timeline Management Software

Jobbeschreibung

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 elevate 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

Nonclinical

• 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.

CDMO

• 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

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 employee communicates frequently with Altasciences employees across Canada and the United States. As such, English is the main language used to correspond between offices.
• The employee frequently communicates with English-only customers outside the province of Quebec

What We Offer

Altasciences offers a wide range of benefits to help employees live healthy and satisfying lives, both on and off the job.

Altasciences benefits include

• Health/dental/vision insurance plans
• RRSP with employer match
• Paid vacation and statutory vacations
• Paid sick leave and bereavement leave
• Employee assistance and telehealth programs

Altasciences’ incentive programs include

• Training and development programs
• Employee orientation bonus program
• Annual performance reviews

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