Global Study Manager – FSP

Thermo Fisher Scientific

Global Study Manager accountable for clinical operational activities in a leading bio-pharma company. Focusing on delivering studies to time, quality, and budget.

Posted 4/23/2026full-timeRemote • 🇧🇬 BulgariaMid-LevelSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

GSM will be accountable for the operational delivery of clinical study/studies to time, quality, and budget
Supporting decision-making at pace and leading study team to achieve overall study deliverables
Proactively and effectively identifies, oversees, and mitigates study risks
Ensures appropriate stakeholder communication, including study status, expectations, risks, and issues
Accountable to operate within the study budget
Effectively leads empowered matrix teams
Responsible for operational input into protocol and informed consent form development, and other key study documents
Leads and conducts investigator meetings and other study related meetings
Leads quality efforts to ensure protocol compliance and continual inspection readiness for assigned studies
Oversees the activities of the countries participating in the study

Requirements

What you’ll need

Bachelor’s degree: life sciences or related discipline
At least 5+ years of relevant study management experience on a global level
In-depth experience in clinical research: study management, monitoring, data management
Must have exposed to clinical study management 'end-to-end' Globally: NA, EMEA, APAC, LATAM – China & Japan, Africa is an asset
Must have proven experience from study feasibility to CSR
Must have at least Ph II and PIII experience – PI & PIV is an asset
Must have cross-functional leadership proven experience, able to drive internal and external meetings
Able to input in clinical protocol, ICF, and other study plan, savvy in clinical study risk management and clinical systems
Strong experience in clinical budget management
Strong experience with vendor management including CRO
Exposed to competent authority Inspections (FDA, EMA, MHRA, PMDA...), being involved in studies pivotal for drug file registration is an asset
Fluent in English, to the level they can negotiate and discuss related to complex topics with any Clinical team member
Excellent stakeholder management and communication skills (oral and written), outstanding interpersonal skills.
Demonstrates leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives
Strong understanding of the clinical study, drug development, sample management, and other associated process and quality requirements, including ICH/GCP guidelines and SOPs
Good project management skills (including scope, budget, timeline, and resource planning and management, and use of associated tools and support where available)

Benefits

Comp & perks

Work Schedule Standard (Mon-Fri)
Fully Remote

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical study managementdata managementclinical budget managementvendor managementrisk managementprotocol developmentinformed consent form developmentstudy feasibilityclinical researchproject management

Soft Skills

leadershipstakeholder managementcommunication skillsinterpersonal skillsdecision-makingteam empowermentmotivationorganizational objectivescross-functional leadershipnegotiation