Clinical Trial Manager I
hace 1 mes
Location: Barcelona, Spain
Job reference: R-198918
Date posted: 05/06/2024
The Global Study Associate (GSA) is a role within Development Operations that serves as a member of a cross-functional study team, supporting delivery of clinical studies across the study lifecycle, including study start-up, conduct and maintenance, close-out and archival. The GSA supports delegated activities for clinical study execution related to timelines, costs, and quality with a focus on maintaining inspection readiness.
The GSA operates in accordance with the Rare Disease Study Team Operating Model for Internal Delivery (rSOLID) and/or clinical outsourcing model, applicable controlled procedures, guidance materials, job aides, current clinical trial regulations, e.g., ICH GCP, and policies and best practices in line with Alexion’s mission, values, and behaviours.
Studies may be across various therapeutic areas and all phases (I-IV, including Late Phase, Non-Interventional, Post Authorization Safety Studies, Registries, Early Access Programs, etc.).
**You will be responsible for**:
- Assist global study teams (GSD, GSAD, GSMs) and support study deliverables by completing delegated study and functional activities, including drafting and maintenance of the study team roster and support study team training requirements.
- Collaborate with global study teams on the preparation, handling, distribution, maintenance, and archival of study related documentation and reports according to the scope of work.
- Initiate and lead set-up, maintenance, and close-out of applicable systems that track study and site compliance and performance within project
Global Study Associate/Clinical Trial Manager I
- Initiate the periodic review of study files and completeness per the TMF Plan (e.g., TMF reviews).
- Collaborate with global study teams on the preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
- Serve as a central contact for global study teams for designated project communications, correspondence, and related documentation.
- Lead and support study related administrative activities, including:
- Preparation of meeting agendas, minutes, and tracking of action items.
- Production of reports and status metrics as requested.
- Timely distribution and maintenance of study related materials.
- Provide administrative support to global study teams related to vendor oversight and vendor contract management.
- Support activities associated with company-sponsored site quality audits and regulatory authority inspections.
- Work on non-drug project work such as Clinical Operations representative in process improvements and/or leading improvement projects as discussed and agreed upon with their manager.
- Support other study and functional activities, as assigned.
**You will need to have**:
- Associates degree or equivalent, in one of the disciplines related to clinical practice/health care, life sciences, or drug development, or commensurate work experience.
- Excellent organizational communication and time management skills.
- Attitude consistent with a team player.
- Mature, collaborative, motivated, self-starter, independent worker and able to prioritize competing activities.
- Proficiency with technological systems (Microsoft Office such as: Excel, PowerPoint, and SharePoint Online, eTMF and Veeva Systems).
- Able to work in a fast-paced working environment adaptable to change when needed.
- Experience working on time sensitive projects.
- Highly proactive and willing to take initiative.
- Strong relationship building skills with peers.
- The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
**We would prefer for you to have**:
- 1-3 years supporting global study teams in a clinical research environment (sponsor, CRO, site(s)).
- Bachelor’s degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development.
- Proficiency with technological systems (Microsoft Office such as: Excel, PowerPoint, and SharePoint Online, eTMF and Veeva Systems).
- Basic knowledge and understanding of Essential Documents, CFR and/or ICH-GCP
- Project management skills and basic PM methodology, including timelines, quality of deliverables, understanding risk-based approach to clinical research
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