Global Study Manager II - Spain - FSP

Parexel International; Spain (TX); Hybrid; USD 104,000 - 162,000; Full time

Job summary

Parexel International is seeking an experienced Global Study Manager to lead and deliver complex, multi-country clinical trials from a fully remote setting. You will guide trial teams, manage timelines, and coordinate with CROs, sites and vendors to meet milestones while ensuring GCP compliance.

The role requires extensive global trial leadership, English fluency, and travel as needed. You will collaborate across functions to optimize data delivery, budgeting, and regulatory responses,

Qualifications

• Minimum 6 years of global study management/leadership experience.
• Experience overseeing CROs and vendors.
• Fluent written and spoken English; strong communication skills.
• Ability to travel as required for global trials/meetings.
• Proficient with trial management systems and MS applications.
• Knowledge of ICH GCP and regulatory guidelines.

Responsibilities

• Provide leadership and direction to the trial team for global studies.
• Steer and direct trial activities, ensuring milestones and KPIs are met.
• Engage patients and sites; communicate with internal and external stakeholders.
• Oversee trial documents, budgets, and data delivery across regions.
• Support CTRs, TMF archiving, and timely data cleaning.
• Coordinate with functions to ensure compliance and quality.

Skills

Global trial leadership

Stakeholder management

English fluency

Travel readiness

Education

Bachelor's degree

Tools

CTMS

EDC

IWRS/IVRS

MS Office

Job description

Parexel is actively recruiting for an experienced Global Study Manager to join us in Poland/Spain.

Temporary position (until April 2027)

100% remote.

Sponsor dedicated.

In this role you will 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.

You will be 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.

Some specifics about this advertised role

• 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.
• Prepare and implement amendments of core documents, including training material updates/retraining as needed.
• Support authority/ethics response to requests as applicable
• In collaboration with other functions, ensures 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.
• Support results/documents disclosure of global registries.

Who are Parexel

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.

We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.

What we are looking for in this role

For every role, we look for professionals who have the determination and courage always to put patient well-being first.

That to us is working with heart.

Here are a few requirements specific to this advertised role

• 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.