GLOBAL Project Manager (FSP), Remote (US) at Thermo Fisher Scientific

North Carolina, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Clinical ResearchIndustries

Requirements

Provides subject matter expertise and operational input into protocol synopsis, final protocol and other study related documents
Challenges study team to ensure operational feasibility, inclusive of patient and site burden
Supports budget development and ensures impacts are adequately addressed
Participates in country and site feasibility/selection process, with a focus on providing country insights, alignment and therapeutic expertise
Develops and manages study timelines
Challenges study team to ensure timelines meet the needs of the clinical development plan
Ensures new team members and vendors are appropriately onboarded
Identifies and oversees trial risk and mitigation
Leader of the cross functional study team
During Early Engagement with Strategic Partner(s) and/or other CROs, lead the development of the Operational Strategy in preparation for Operational Strategy Review; focus on ensuring accurate assumptions are applied and robust risk management plans are in place
Provide oversight/support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly
Supports/reviews study budget planning and management and accountable for external spend related to study execution
Works closely with COM (if applicable) and COPL, Global Program Management, and Finance to ensure on a regular basis that budgets, enrollment, and gaiting are accurate; Communicates study status, cost and issues to COM and COPL; serve as escalation point for all vendors managed by Strategic Partner and/or other CROs
Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted
Specific areas of sponsor oversight include, but are not limited to: Review and approval of key monitoring documents/plans, periodic review of outputs, decisions and actions related to monitoring; Conduct Oversight Monitoring Visits, as applicable; Review and endorsement of relevant study plans, as applicable; Study team meeting management and attendance when necessary; regular review of meeting agendas and minutes; Review of outcomes/actions related to protocol deviations review; primary purpose of review is to support the identification of trends across sites and/or the study; Documented review and monitoring of issues, risks and decisions at the study level and implementation of appropriate mitigation strategies; Review and ownership of trial operational data (e.g. CTMS); Review and provide oversight of internal trial reports; In partnership with data management, review and pressure test all database timelines and plans; ensure strong linkage between the strategy (i.e., filing/registration, data gener

Responsibilities

Lead or support study operational strategy and planning and oversee execution of select clinical studies (global/regional and/or local country) for assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan
In close collaboration with the Clinical Operations Program Lead (COPL) and the Clinical Operations Manager (COM) (if applicable): Support or oversee the execution of select study/ies in assigned clinical program(s) in compliance with quality standards on schedule and on budget
Oversee Strategic Partners and/or other CROs and other vendors to meet obligations described in ICH-GCP and business objectives
Accountable for planning and operational strategy and execution for assigned clinical trials

Skills

Key technologies and capabilities for this role

Clinical Study ManagementICH-GCPStudy PlanningRisk ManagementVendor ManagementCRO OversightProtocol DevelopmentBudget ManagementTimeline ManagementSite FeasibilityCross-Functional Leadership

Questions & Answers

Common questions about this position

Is this position remote?

Yes, the position is remote within the US.

What is the salary range for this role?

This information is not specified in the job description.

What are the key responsibilities of this Clinical Study Manager role?

The role involves leading or supporting study operational strategy and planning, overseeing execution of clinical studies, managing Strategic Partners/CROs/vendors, developing study timelines and budgets, and leading cross-functional study teams.

What kind of studies will this role manage?

The role manages select clinical studies including global/regional/local country studies, PTA (Post Trial Access), RATIO (R&D Asset Transition and Integration Office), and studies in wind down, potentially across multiple programs.

What makes a strong candidate for this Clinical Study Manager position?

Strong candidates have expertise in clinical trial planning and execution, experience overseeing CROs and vendors, skills in budget and timeline management, and the ability to lead cross-functional teams while ensuring compliance with ICH-GCP.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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