Global Study Associate – FSP
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Job Description
Global Study Associate supporting Parexel’s multi-phase clinical trials in Spain or Poland. Managing TMF documentation, site oversight, vendors, monitoring, and study data activities.
Responsibilities:
- Support Phase 1, 2, 3, and 4 clinical studies with guidance
- Support study and site feasibility, start-up, maintenance, and close-out activities
- Manage study and site essential document review, collection, and tracking
- Support preparation and maintenance of study documents and manuals
- Provide oversight of the Trial Master File (TMF)
- Ensure study documents are received, reviewed, and filed in accordance with SOPs, GCP, and applicable regulations
- Organize study-related meetings, prepare agendas, take minutes, and maintain risk, issue, and decision logs
- Lead and present at study-related meetings as required
- Perform applicable site monitoring and co-monitoring visits
- Address internal and site quality assurance findings from audits
- Manage, coordinate, and oversee third-party vendor activities
- Perform study tracking and maintenance, including study status, enrollment, site queries, deviations, and study-level documents and plans
- Participate in clinical trial team meetings and collaborative efforts such as protocol development and CRO selection
- Support study site oversight, including site performance, metrics, and monitoring report review
- Support study data activities, including data review, query creation and resolution, deviation reviews, and safety reviews
- Work cross-functionally and provide oversight of CRO and vendor activities
- Review and verify contracted vendor activities, including vendor invoice review
- Support study reporting and tracking using applicable systems and technology
- Support study leads in cross-functional alignment of study timelines
- Complete required training, timesheets, expense reports, and CV updates
- Maintain knowledge of and comply with Parexel processes, ICH-GCPs, and other applicable requirements
Requirements:
- A BA or BS degree, a nursing degree, or an equivalent qualification
- At least 3 years of experience in clinical studies as a SCRA or Lead CRA
- Working knowledge of Good Clinical Practice (GCP) regulations and Standard Operating Procedures
- Understanding of study phases and how they apply to clinical development
- Working knowledge of electronic systems, including the Trial Master File and CTMS (e.g., Veeva Vault, Smartsheet, SharePoint)
- Knowledge of the principles and practices of computer applications in database management
- 10% to 20% travel may be required
- Strong verbal and written communication skills
- Ability to work independently and as part of a team
- Advanced knowledge of Microsoft Word, Excel, and PowerPoint
- Ability to prioritize and manage multiple tasks simultaneously
Benefits:
- Premium salary
- Attractive benefits
- Medical care plan: Health, Dental & Vision
- Life Assurance
- Excellent work environment
- Culture of teamwork and collaboration
- People who motivate and face challenges together
- Innovative technology
- Excellent training
- Paid time off
- Life insurance
- Health insurance
- Additional benefit offerings in accordance with the terms of applicable plans
- Additional incentives, bonuses, or other compensation programs may be available for eligible roles
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