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Senior Clinical Project Analyst
SYNVIASenior Clinical Project Analyst at Synvia, supporting clinical trials and ensuring compliance with regulations and protocols. Excellent opportunity for healthcare professionals to innovate in dynamic environments.
Core Competencies
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Demonstrates expertise in clinical trial administration, including maintaining Trial Master Files (TMF) and Investigator Site Files (ISF), while ensuring compliance with Good Clinical Practice (GCP) and regulatory requirements. Proficient in supporting clinical research activities and collaborating with study teams to facilitate successful trial execution.
ATS Keywords
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About the role
Key responsibilities & impact- Conduct training relevant to your role and keep training records up to date;
- Assist with administrative aspects of clinical trials, providing support to the study team (CRAs/monitors and clinical project managers);
- Assist in collecting and preparing documents from investigative sites during the conduct of the clinical trial;
- Prepare the study's Trial Master File (TMF) and assist in its ongoing maintenance;
- Prepare the Investigator Site File (ISF);
- Perform clinical trial activities in accordance with applicable regulations, Good Clinical Practice (GCP), and protocol requirements;
- Support meeting activities such as organization, planning, and minute-taking;
- Provide support to clinical research associates/monitors, clinical project managers, monitor managers, and the head of operations;
- Assist in identifying potential investigative sites;
- Perform co-monitoring as part of training and support CRAs during site monitoring visits;
- Support the clinical research monitor in the absence of the clinical project manager.
Requirements
What you’ll need- University degree in a health-related field;
- Intermediate English;
- Knowledge of Good Clinical Practice (GCP), Initiation Visit, Routine Monitoring, Close-out, and site qualification;
- Previous experience as a clinical research analyst or clinical project analyst in a CRO or pharmaceutical company.
Benefits
Comp & perks- Commuter allowance (transportation voucher);
- Parking (subject to availability);
- Health insurance with no monthly premium for the employee, with co-payments for tests and consultations;
- Dental plan with employee co-pay;
- Life insurance at no cost to the employee;
- Flexible meal/food allowance;
- Access to SESC partnership benefits;
- Physical wellness program — TotalPass;
- Day off for healthcare professionals;
- Childcare assistance (per internal policy).