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Sr Project Manager - NIS Experience - FSP

  • Job
    Full-time
    Mid & Senior Level
  • Science
    Research & Development
  • Milan

AI generated summary

  • You need an MS/PhD with 3+ years or a BS/Nurse with 5+ years in global clinical trial management, CRO oversight, and budgeting, plus strong communication, problem-solving, and cultural awareness skills.
  • You will manage clinical studies, oversee CRO deliverables, drive project strategy, coordinate teams, ensure inspection readiness, and develop study plans and budgets while tackling site issues.

Requirements

  • MS/PhD – minimum of 3 years of proven experience
  • BS/Nurse – minimum of 5 years of proven experience
  • Extensive global clinical trial/study management experience
  • Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
  • Demonstrated study management / leadership experience
  • Demonstrated oversight of CROs
  • Demonstrated experience in managing Per Subject Costs, vendor & ancillary, and monitoring costs projections & spend
  • Understands how to work with vendors to accomplish tasks
  • Ability to interpret study level data & translate and identify risks
  • Ability to proactively identify & mitigate risks around site level in study execution
  • Understands feasibility of protocol implementation
  • Country level cultural awareness and strong interpersonal skills
  • Keen problem-solving skills
  • Excellent communication skills, both written and verbal. Must be fluent in English.
  • Detail oriented & possesses technical expertise (e.g., spreadsheets, metrics & data flow management)

Responsibilities

  • The Study Manager has global responsibility for one or more studies of moderate complexity generally with responsibility for all study management aspects of assigned studies
  • Provides quality oversight to the Contract Research Organization (CRO) and of the CRO deliverables related to study execution
  • Leads and coordinates the execution of a clinical trial from Study start-up through Database close and inspection readiness to ensure timely delivery of quality study data
  • Study Managers may also input to and support compilation of sections to Clinical Study Reports
  • Will provide leadership to the teams in the setting of realistic recruitment targets and delivery milestones as the single point of accountability for detailed study start-up and monitoring plans and for delivery to the agreed plans
  • Works with functional lines and directly with CRO line functions to resolve or triage site level issues
  • Will drive decision making and work closely with the Clinical Project Manager to provide input to operational strategy
  • For studies where more than one Study Manager is assigned, may be required to act as ‘lead’ study manager, and will coordinate activities of the other Study Managers assigned
  • Accountable for the development of realistic detailed study startup and monitoring plans as well as study delivery
  • Accountable for conducting country level feasibility in collaboration with Global Clinical Trial Execution and CROs, reviewing Pre-trial Assessment outputs, approving sites, and assessing site activation plans
  • Leads study risk planning process in context of site and subject
  • Coordinate study/protocol training & investigator meetings
  • Develops and provides key inputs to Clinical Trial Budget
  • Leads inspection readiness activities related to study management and site readiness
  • May produce or review model Informed Consent Document (ICD) and study/country/site level ICD, as appropriate
  • May expand study design document into approved protocol template while incorporating input from other team members (e.g., Clinician, Clinical Pharmacology Lead, Supply Chain Lead, Statistician, Outcomes Research Representative, Clinical Assay Group, etc.)

FAQs

What is the work schedule for this position?

The work schedule is standard, Monday through Friday.

What environmental conditions will I be working in?

You will be working in an office environment.

What is the main focus of this role?

The main focus of this role is to manage one or more clinical studies, ensuring timely delivery of quality study data while providing oversight to the Contract Research Organization (CRO) and coordinating with client personnel.

What qualifications are required for this position?

A Master's degree or PhD with a minimum of 3 years of proven experience, or a Bachelor's degree or nursing degree with a minimum of 5 years of proven experience in global clinical trial/study management.

What experience is necessary for candidates applying for this job?

Candidates should have demonstrated study management and leadership experience, oversight of CROs, and experience managing costs related to subjects, vendors, and monitoring.

What skills are essential for success in this position?

Essential skills include the ability to interpret study-level data, proactive risk identification and mitigation, cultural awareness, problem-solving skills, and excellent communication skills in English.

Will I be working with external vendors?

Yes, the role involves collaborating with vendors to accomplish various tasks related to study management.

Is fluency in English required for this position?

Yes, fluency in English is required, both in written and verbal communication.

Does Thermo Fisher Scientific have a commitment to diversity?

Yes, Thermo Fisher Scientific values diverse experiences, backgrounds, and perspectives as part of its mission and workplace culture.

The World Leader In Serving Science

Science & Healthcare
Industry
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Employees

Mission & Purpose

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.