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Sr Project Manager - NIS Experience - FSP

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

AI generated summary

  • You must have an MS/PhD with 3+ years or BS/Nurse with 5+ years in global clinical trial management, CRO oversight, budget control, risk mitigation, and excellent communication skills.
  • You will manage clinical trials, oversee CRO deliverables, coordinate study start-up, ensure quality data delivery, and lead risk planning and inspection readiness activities.

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 the Sr Project Manager position?

The work schedule is standard Monday to Friday.

What are the environmental conditions for this role?

The environmental conditions for this role are office-based.

What is the primary responsibility of the Sr Project Manager?

The Sr Project Manager has global responsibility for one or more studies of moderate complexity and is accountable for all study management aspects of assigned studies.

Will I be working with clients directly in this role?

Yes, this role will be embedded within a client dedicated team, working alongside the client's personnel as well as PPD colleagues.

What qualifications are required for this position?

Candidates must have an MS/PhD with a minimum of 3 years of proven experience, or a BS/Nurse with a minimum of 5 years of proven experience, as well as extensive global clinical trial/study management experience.

What kind of experience is necessary for this role?

Demonstrated study management/leadership experience and oversight of CROs are necessary, along with experience in managing per subject costs and vendor-related costs.

Are there specific skills and abilities required for success in this position?

Yes, successful candidates should have strong problem-solving skills, excellent communication skills (both written and verbal), detail orientation, and the ability to interpret study-level data and identify risks.

Is fluency in English required for this role?

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

What is the company's mission as stated in the job description?

The company's mission is to enable customers to make the world healthier, cleaner, and safer.

How can I apply for this position?

You can apply for the position by visiting http://jobs.thermofisher.com.

The World Leader In Serving Science

Science & Healthcare
Industry
10,001+
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.