Sobre esta vaga de Centralized Study Analyst na Fortrea
Join Fortrea as a Centralized Study Analyst and play a key role in supporting the delivery of global clinical trials. This is a full-time, permanent position based in Bulgaria, offering the flexibility to work from home, with the option to work from our Sofia office if preferred.
In this role, you will collaborate with Project Managers, and cross-functional study teams worldwide, helping to manage study systems, documentation, reporting, site payments, and clinical trial operations. You will gain valuable exposure to the full clinical trial lifecycle while contributing to the successful execution of international studies.
This is an excellent opportunity for someone with clinical research experience who is looking to broaden their knowledge, work on global projects, and develop their career within a supportive and collaborative environment.
Summary of Responsibilities:
- To complete other duties/activities as assigned by study management team, but not limited to:
- Manage clinical systems and access management.
- Manage study documents and support eTMF management.
- Maintain study databases (CTMS, IWRS, EDC, etc.)
- Support study team in data review and support activities.
- Track and follow up with CRAs for outstanding issues.
- Support in generating the study specific reports.
- Manage internal/external communications.
- Assist in ensuring training compliance for study teams.
- Manage study payments (Site and Vendor).
- Follow up with CRA for resolution of the outstanding issues/action items related to assigned tasks.
- Assist the Lead for any study specific data review related tasks.
- Draft and send study specific reports as per the study team instructions.
- Perform any other data review related tasks as per the project team instructions.
- Study Support:
- Generate Study Reports and perform analysis.
- Perform Access management on applicable study systems.
- Perform study system set up on new awarded studies.
- CTMS compliance management.
- Manage project communications.
- Assist project teams for other study support activities.
- To follow all applicable departmental Standard Operating Procedures and Work Instructions:
- To complete required trainings according to required timelines.
- To complete day-to-day tasks ensuring quality and productivity.
- To manage project and technical documentation in an appropriate manner.
- To provide administrative and technical support to internal departments and teams as needed.
- To perform checks to ensure quality of work completed.
- To ensure timely escalation and issue resolution as needed.
- To track and report metrics as determined by management according to required timelines.
- To participate in process improvement opportunities and assist with the implementation of revised processes and procedures.
- To assist in the document management (including document template creation, collection, review, processing and tracking up to eTMF filing) for all documents in the scope of agreed processes/activities or within the scope of Centralized Delivery Team throughout the study duration.
- To assist in the preparation of new investigator submission packages for site/regulatory submission.
- To assist in Investigator Payment Processing, Site budget validation and related activities.
- To assist the study start up teams with tasks required for site start up activities.
- To review, Support, Manage or assist in Managing the site clinical trial contracts in accordance with defined processes and timelines.
- All other duties as needed or assigned.
Qualifications (Minimum Required):
- University/College Degree (Life Science preferred), or certification in an allied health profession from an appropriate accredited institution (Ex. Nursing certification, Medical or laboratory technology).
- 03-05 years of work experience in clinical research, including a strong working knowledge of the ICH-GCP guidelines and all other applicable guidelines and regulations.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Experience (Minimum Required):
- At least 2 years of experience in a similar role.
- Other required work-related experiences:
- Demonstrated ability to organize and communicate effectively.
- Demonstrated ability to pay attention to detail.
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