Project Manager - Pregnancy Registries Team

Thermo Fisher Scientific•Wilmington, NC

About The Position

The Senior Project Manager serves as the Project Lead and primary sponsor contact, accountable for the overall delivery of project quality, time, and cost. The role establishes and communicates customer expectations to the project team with minimal direction, ensures internal and external escalation pathways are followed, and leads cross-functional teams to meet or exceed deliverables. The position manages projects of increasing complexity, including work involving multiple services, regions or countries, therapeutic complexity, or financial scope. Experience working with Pregnancy Registries is required for consideration. The Senior Project Manager is responsible for project-level sponsor communication, delivery, financial stewardship, risk identification, issue resolution, and compliance with organizational policies, SOPs, ICH-GCP, regulatory requirements, and project-specific requirements. The role also includes mentoring and contributing to process improvement initiatives. Work is performed in an office/laboratory and/or clinical environment. Conditions may include exposure to biological fluids and potentially infectious organisms, as well as electrical office equipment. Personal protective equipment, including protective eyewear, garments, and gloves, is required.

Requirements

  • Experience working with Pregnancy Registries is required for consideration.
  • Bachelor's degree or equivalent and relevant formal academic or vocational qualification.
  • Comparable to 8+ years of previous experience providing the knowledge, skills, and abilities needed to perform the job.
  • Technical and systems competency, including Microsoft Outlook, Word, Excel, and PowerPoint, as well as organizational systems such as CTMS, Preclarus, and Clarity.
  • Ability to delegate and effectively prioritize project team workload and resources in a frequently changing environment.
  • Effective oral and written communication and presentation skills.
  • Proactive, solutions-oriented, and adaptable when priorities and situations change.
  • In-depth therapeutic area knowledge and knowledge of clinical development guidelines and directives.
  • Advanced knowledge of key cross-functional project management principles, including time, quality, and cost.
  • Interpersonal skills, including the ability to lead, motivate, and coordinate cross-functional project teams.
  • Strong customer service skills and ability to proactively address and prioritize expectations.
  • Good judgment and decision-making skills, with the ability to apply critical, analytical, and strategic thinking to complex or ambiguous situations.
  • Strong negotiation skills and ability to influence others and achieve results, including cross-cultural awareness.
  • Strong financial acumen and ability to minimize risk by proactively managing and adjusting budgets, forecasts, and resources.
  • Ability to work independently with minimal supervision.

Responsibilities

  • Serve as the primary project-level contact between the sponsor and the organization.
  • Ensure internal and external escalation pathways and communication rules are followed.
  • Where required by project scope, clarify responsibilities and communication pathways for secondary project leads, such as regional leads or leads for vendors or subsets of delivery.
  • Own and drive overall cross-functional project delivery across time, cost, and quality.
  • Provide project-level financial stewardship, including understanding the contract, aligning resources to budget, managing out-of-scope activity, driving contract modification processes and negotiations, and keeping team execution on schedule.
  • Establish, communicate, and manage customer expectations to support optimal project delivery.
  • Drive project-level risk identification and issue resolution using RBQM/RESOLVE.
  • Ensure project team compliance with organizational policies, SOPs, ICH-GCP, regulatory requirements, and project-specific requirements.
  • Act as a mentor.
  • Develop or contribute to process improvement initiatives.
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