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Thermo Fisher Scientific

(Sr) Project Manager - eCOA/Rater Oversight - Remote based in the US

RemoteUnited States only
Published
Role
Project Management
Experience
Lead
Employment
Full-time
Company size
Enterprise
Salary not disclosed
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Open to US only. Set where you work from to check your eligibility.

No BS summary

Senior project manager with 8+ years of related experience, clinical trial project management, eCOA systems, and Rater Training/Readiness. Must be US-based remote and able to lead cross-functional clinical projects across time, cost, quality, sponsor communication, risk, compliance, and budgets.

Core skills

eCOARater Training

Required skills

Microsoft OutlookMicrosoft WordMicrosoft ExcelMicrosoft PowerPointCTMSPreclarusClarity

What you'll do

  • Serve as the Project Lead and primary sponsor contact and be accountable for the overall delivery of the project quality, time, and cost on behalf of the organization.
  • Establish and communicate customer expectations to the project team with minimal direction.
  • Ensure that escalation pathways are adhered to internally and externally.
  • Lead the cross functional project team to meet or exceed deliverables.
  • Manage project(s) of increasing complexity, such as multi-service, multi-region/country, therapeutic complexity, and financial scope.
  • Serve as the primary contact between the sponsor and the organization at the project level.
  • Ensure escalation pathways adhered to internally and externally, including Rules of Engagement and communication pathways.
  • On projects where the scope requires, ensure clear delineation in responsibilities and communication pathways for secondary project leads, such as lead in a specific region, lead for a specific vendor(s), or subset of delivery.
  • Drive and own the overall delivery of the cross-functional project, including time, cost, and quality.
  • Ensure financial stewardship at a project level by demonstrating an intimate understanding of the contract, resource alignment to budget, management of Out of Scope activity, drive the Con Mod process/negotiations and team execution to timelines.
  • Establish, communicate and manage customer expectations to achieve optimal delivery during the project.
  • Drive Risk Identification and Issue Resolution at project level, including RBQM/RESOLVE.
  • Ensure project team compliance with organization policies, SOPs, ICH-GCP, regulatory and project specific requirements.
  • Act as a mentor.
  • Develop or contribute to process improvement initiatives.

What they require

  • Seeking a candidate with demonstrated clinical trial project management experience with eCOA systems and Rater Training/Readiness.
  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
  • Previous experience that provides the knowledge, skills, and abilities to perform the job, comparable to 8+ years’.
  • Technical and systems competency, such as computer skills, to include effective use of systems and applications such as Microsoft Outlook, Word, Excel and PowerPoint, as well as organization systems CTMS, Preclarus, Clarity.
  • Ability to delegate and effectively prioritize workload and resources for project team members in a frequently changing environment.
  • Effective oral and written communication and presentation skills.
  • Proactive, solutions oriented and adaptable in changing priorities and situations.
  • In-depth therapeutic area knowledge and clinical development guidelines and directives.
  • Advanced knowledge of the key principles of cross functional project management, including Time, Quality, Cost.
  • Effective interpersonal including the ability to lead, motivate and coordinate cross-functional project teams.
  • Strong customer service skills with the ability to proactively address and prioritize expectations.
  • Good judgment and decision making skills and proven ability to apply critical and analytical and strategic thinking skills to manage complex/ambiguous situations.
  • Strong negotiation skills with ability to influence others and achieve results, including a cross cultural awareness.
  • Strong financial acumen with the knowledge and ability to minimize risk by proactively managing and adjusting budgets/forecasts/resources.
  • Ability to work independently with minimal supervision.
  • Work is performed in an office/ laboratory and/or a clinical environment.
  • Exposure to biological fluids with potential exposure to infectious organisms.
  • Exposure to electrical office equipment.
  • Personal protective equipment required such as protective eyewear, garments and gloves.

Benefits

  • You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

multinational company providing scientific instrumentation

Life SciencesEnterprisethermofisher.com/

What people say about this company

3.4/ 5

Salary not disclosed