Global Study Manager II

🔥 0 minutes ago

🌐 Spain, Poland – Remote

🇪🇸 Spain – Remote 🇵🇱 Poland – Remote

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

👔 Manager

👻 Ghost score 10%

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Provide leadership and direction to the trial team and accountability for the overall success and delivery of assigned clinical trials according to defined milestones and KPIs • Steer and direct clinical trial activities, including patient and site engagement • Communicate and interact directly with multiple internal and external stakeholders and team members globally, across multiple countries or regions • Plan trial timelines and assess operational feasibility • Oversee trial preparation to ensure trial team members are aligned and on track • Support development of trial-level documents owned by other functions, including Statistics, Data Management, Study Physician, Medical Writing, and Site Monitoring • Verify and provide input into country allocation and oversee trial feasibility • Maintain oversight during trial conduct, including adherence to GCP, global and local regulatory requirements, SOPs, and continuous risk monitoring and mitigation • Support budget oversight, clinical quality monitoring, SMC/DMC management, and safety reporting • Prepare and implement core-document amendments, including training-material updates and retraining • Support authority and ethics responses to requests • Ensure timely cleaning and delivery of clinical trial data • Coordinate and support the trial medical writer in providing the clinical trial report • Ensure timely, complete, and compliant archiving of relevant global documents in the TMF, including vendor documents • Support results and document disclosure of global registries

🎯 Requirements

• Bachelor’s degree • Minimum 6 years of relevant global study management/leadership experience • Experience with oversight of CROs and vendors • Experience managing per-subject costs, vendor and ancillary costs, and monitoring cost 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 Teams, MS Office, Project, CTMS, EDC, and IWRS/IVRS • Knowledge of ICH GCP and relevant regulatory guidelines/directives • Demonstrated interpersonal and leadership skills • Ability to understand and implement strategic direction and guidance for respective clinical studies • Effective verbal, written, and presentation communication skills

🏖️ Benefits

• Temporary position until April 2027 • 100% remote • Ability to work outside 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