Parexel is looking for a Global Study Manager II to lead clinical trial delivery in Poland or Spain. At Parexel, we all share the same goal—to improve the world's health. We take our work personally and are committed to making a difference. In this role, you will provide leadership and direction to the trial team, accountable for the overall success and delivery of assigned clinical trials according to defined milestones and KPIs.
What You'll Do
- Account for the accurate planning and operational feasibility of trial timelines and oversee trial preparation.
- Support the development of trial-level documents owned by other functions like Statistics, Data Management, and Medical Writing.
- Verify and provide input into country allocation and oversee trial feasibility.
- Maintain oversight during clinical trial conduct, ensuring adherence to GCP, regulatory requirements, SOPs, and continuous risk monitoring.
- In collaboration with other functions, ensure budget oversight, support clinical quality monitoring, and manage SMC/DMC and safety reporting.
- Prepare and implement amendments to core documents, including training material updates and retraining.
- Support responses to authority and ethics requests as needed.
- Ensure timely cleaning and delivery of clinical trial data and coordinate with the trial medical writer for the CTR.
- Be responsible for the timely, complete, and compliant archiving of all relevant global documents in the TMF.
- Support results and document disclosure for global registries.
What We're Looking For
- Bachelor’s degree and a minimum of 6 years of relevant global study management or leadership experience.
- Experience with oversight of CROs and vendors.
- Experience managing per-subject costs, vendor, ancillary, and monitoring cost projections and spend.
- Fluency in written and spoken English is required.
- Ability to work outside of core business hours to support global trials or initiatives.
- Ability to travel as required for 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 Teams, MS Office, Project, CTMS, EDC, IWRS/IVRS.
- Knowledge of ICH GCP and relevant regulatory guidelines.
- Demonstrated interpersonal and leadership skills.
- Ability to understand and implement strategic direction and guidance for assigned clinical studies.
- Effective communication skills via verbal, written, and presentation abilities.
Technical Stack
- Microsoft Teams
- MS Office
- Microsoft Project
- CTMS
- EDC
- IWRS/IVRS
Work Mode
This is a local-country role based in Poland or Spain.
