Clinical Operations Specialist, Fluent French Required
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Job Description
Clinical Operations Specialist managing site activities and ensuring compliance with clinical study protocols at Syneos Health. Collaborating with monitoring staff for smooth operation of trials.
Responsibilities:
- Responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions
- Assists Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines
- Creates and assists with maintenance of Trial Master File (TMF) and project files, including participation in file audits
- Prepares and maintains site manuals, reference tools and other documents
- Maintains, updates, and inputs clinical tracking information into databases
- Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client
- Manages shared mailbox, processes site requests and routes correspondence appropriately
- Coordinates the ordering, packaging, shipping and tracking of site supplies and materials
- Assists with coordination of team meetings, attends meetings and prepares accurate meeting minutes and action items
- May handle receipt, tracking and disposition of Case Report Forms and Queries
- Maintains overall awareness in the field of clinical research by completing all necessary and assigned training
Requirements:
- High School diploma or equivalent
- Good communication and interpersonal skills
- Ability to embrace new technologies
- Bachelor’s degree in life sciences or a related field, or equivalent combination of education and experience in clinical research
- Prior experience supporting clinical trials within a CRO, pharmaceutical, or biotechnology environment
- Strong organizational skills with the ability to manage multiple priorities and maintain accuracy in a fast-paced setting
- Excellent written and verbal communication skills in both French and English, with the ability to interact effectively with global study teams and investigator sites.
Benefits:
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to building an inclusive culture – where you can authentically be yourself.
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