Healthcare professional preparing and assisting in surgeries at Main - Klinik Ochsenfurt. Responsible for patient care and operational organization in the operating theater.
About the role
- Clinical Operations Specialist managing site compliance and supporting clinical monitoring in a highly integrated biopharmaceutical organization. Collaborating with teams in clinical development while ensuring accurate clinical tracking.
Responsibilities
- 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
- Communicating with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines
- Creates and assists with maintenance of project files
- Handles project correspondence
- Participates 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
- Manages shared mailbox, processes site requests and routes correspondence appropriately
- Coordinates the ordering, packaging, shipping and tracking of site supplies and materials
- Attends meetings and prepares accurate meeting minutes and action items
- Anticipates, identifies and resolves potential issues and implements corrective actions
- Completes all necessary and assigned training
- May provide training or mentorship to more junior level Clinical Operations Specialists (COS)
Requirements
- Experience in Clinical Research with CTA Tasks is a must
- Associates degree preferred or equivalent
- Experience in clinical research/pharma/biotech or related field considered
- Good knowledge of medical terminology, clinical data, and ICH/GCP preferred
- Ability to successfully prioritize and work on multiple tasks
- Strong attention to detail, accuracy and organizational skills
- Excellent communication, presentation, and interpersonal skills
- Ability to embrace new technologies
- Minimal travel up to 10% may be required
Benefits
- Career development and progression
- 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
Tech skills
Location requirements
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