
Clinical Operations Specialist
Syneos Health
full-time
Posted on:
Location Type: Hybrid
Location: Munich • 🇩🇪 Germany
Visit company websiteJob Level
Mid-LevelSenior
About the role
- 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
- Minimal travel up to 25% may be required
Benefits
- Health insurance
- Professional development opportunities
- Flexible working arrangements
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Trial Master File (TMF) managementclinical trackingdocument managementfile auditssite managementregulatory document trackingCase Report Forms handlingmeeting coordinationaction item preparation
Soft skills
communication skillsinterpersonal skillsorganizational skillsteam collaborationattention to detailadaptability to new technologies
Certifications
High School diploma or equivalent