Global Study Manager II

Parexel

Global Study Manager providing leadership and direction in clinical trials for Parexel across multiple countries. Spearheading trial activities and ensuring compliance with regulatory requirements.

Posted 4/22/2026full-timeRemote • 🇪🇺 Anywhere in EuropeMid-LevelSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Provide leadership and direction to the trial team and is accountable for the overall success and delivery of their assigned clinical trial according to defined milestones and KPI’s.
Responsible for steering and directing clinical trial activities, including patient and site engagement activities, direct communication and interaction with multiple internal and external stakeholders, and team members on a global, multi country or regional basis.
Accountable for the accurate planning and operational feasibility of trial timelines; and oversight of trial preparation to ensure trial team members are aligned and on track.
Supports development of trial level documents owned by other functions (e.g. Statistics, Data Management, Study Physician, Medical Writing, Site Monitoring).
Verifies and provides input into the country allocation and oversees trial feasibility.
Maintains oversight during clinical trial conduct including adherence to GCP and all global and local regulatory requirements; compliance with SOPs and continuous risk monitoring/mitigation.
In collaboration with other functions, ensures budget oversight, including support of regular clinical quality monitoring, SMC/DMC management and safety reporting.
Prepares and implements amendments of core documents, including training material updates/retraining as needed.
Supports authority/ethics response to requests as applicable.
Collaborates with other functions, ensuring timely cleaning and delivery of clinical trial data.
Coordinates and supports trial medical writer in providing the CTR.
Responding for timely, complete and compliant archiving of all relevant global documents in the TMF, including all required documents from vendors.
Supports results/documents disclosure of global registries.

Requirements

What you’ll need

Bachelor’s degree and minimum 6 years of relevant global study management/leadership experience
Experience with oversight of CROs and vendors
Experience in managing per subject costs, vendor and ancillary and monitoring costs projections and spend
Fluency in written and spoken English required
Ability to work outside of core business hours, as required, to support global trials or initiatives
Ability to travel, as required, including IMs, vendor kick off and re-set meetings, and client internal global or department level meetings
Technical proficiency in trial management systems and MS applications, including but not limited to Teams, MS Office, Project, CTMS, EDC, IWRS/IVRS.
Knowledge of ICH GCP and relevant regulatory guidelines/directives.
Demonstrated interpersonal & leadership skills.
Ability to understand and implement the strategic direction and guidance for respective clinical studies.
Effective communication skills via verbal, written and presentation abilities.

Benefits

Comp & perks

Parexel is a leading global clinical research organization providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry
Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise
Improving the world's health
Advancing clinical research in healthcare’s most complex areas

ATS Keywords

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Hard Skills & Tools

clinical trial managementbudget oversighttrial feasibility assessmentclinical quality monitoringdata cleaningdocument archivingKPI managementrisk monitoringamendment preparationvendor management

Soft Skills

leadershipinterpersonal skillseffective communicationstrategic direction implementationteam collaborationproblem-solvingadaptabilitytime managementpresentation skillsstakeholder engagement