16 sep
|
Parexel
|
Almería
Overview In this role you lead global clinical trial activities to ensure on-time delivery and high-quality results within Parexel's sponsor-driven environment. You guide cross‐functional trial teams, manage timelines and budgets, and ensure regulatory compliance across regions. You partner with internal and external stakeholders to translate strategy into executable study plans and ensure data integrity and timely reporting.
This is a remote, sponsor‐dedicated position with a focus on patient‐centric outcomes and trial excellence.
Compensaciones / Incentivos remote work sponsor dedicated role temporary position until April 2027
Spain remote location global collaboration opportunity to impact patient outcomes
Responsabilidades
Provide leadership and direction to the trial team for overall trial success and milestone delivery
Plan and oversee trial timelines and feasibility, aligning team members across regions
Contribute to trial-level documents and collaborate with Statistics, Data Management, Medical Writing, and Site Monitoring
Oversee country allocation and trial feasibility, ensure GCP compliance and regulatory adherence
Support budget oversight, monitoring costs and vendor/sponsor-related expenditures
Prepare amendments to core documents and update training materials
Respond to authority/ethics requests as needed
Coordinate data cleaning and timely delivery of trial data; support CTR with Medical Writer
Ensure archiving of integral trial documents in TMF and vendor documentation
Support results/disclosure for global registries
Engage with vendors and CRO oversight to ensure quality and timelines
Requisitos principales Bachelor minimum 6 years of global study management/leadership experience experience with oversight of CROs and vendors experience managing per-subject costs and vendor/monitoring spend projections fluency in written and spoken English ability to work outside core business hours and travel as needed technical proficiency in trial management systems and MS applications (Teams, MS Office, Project, CTMS, EDC, IWRS/IVRS)
knowledge of ICH GCP and regulatory guidelines demonstrated interpersonal and leadership skills ability to implement strategic direction for clinical studies effective verbal, written, and presentation communication skills interpersonal skills leadership clear communication
CTMS
EDC
IWRS/IVRS
📌 Global Study Manager II - Spain - FSP (Almería)
🏢 Parexel
📍 Almería