Training position for Operationstechnischer Assistent OTA at Klinikum Starnberg. A responsible role in patient care and preparation for surgical procedures.
About the role
- Clinical Ops Specialist managing compliance and site management for biopharmaceutical studies. Collaborating with clinical teams and ensuring protocol adherence across assigned projects.
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
- Minimal travel up to 25% may be required
Benefits
- supportive and engaged line management
- technical and therapeutic area training
- peer recognition
- total rewards program
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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