Clinical Operations Manager overseeing clinical operations and trial execution at Novo Nordisk. Driving team performance and collaborating with global project teams in the Czech Republic.
About the role
- Clinical Operations Specialist at Syneos Health supporting compliance and operational activities in clinical research. Collaborating with teams to maintain clinical tracking databases and project files while performing site management roles.
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
- Health insurance
- Professional development opportunities
- Flexible working arrangements
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Senior Clinical Project Manager at AstraZeneca leading clinical trial teams for clinical studies execution. Focusing on objectives and collaboration with stakeholders for quality and efficiency in processes.
Werkstudent in klinischer Forschung für Alcedis, Unterstützung in der Durchführung klinischer Studien. Praktische Erfahrung in einem modernen Umfeld mit flexiblem Stundenplan.
Executive Director leading global execution of multiple Phase III clinical trials in oncology at Summit Therapeutics. Building and mentoring a high - performing Clinical Operations organization within a fast - paced biotech startup.
Executive Director, Clinical Operations at Summit Therapeutics leading global Phase III oncology clinical trials. Accountable for clinical trial delivery and managing a high - performing Clinical Operations organization.
Project Assistant supporting the Clinical Operations department in the organization and execution of clinical studies. Involves collaboration with study centers and training investigators primarily in Germany.
Director of Clinical Operations overseeing phase 1 - 3 clinical trials in oncology at Summit Therapeutics. Responsible for managing cross - functional teams and ensuring compliance with regulations.
Director of Clinical Operations at Summit Therapeutics managing clinical trials and study execution for oncology. Responsible for overseeing vendor relations, budget management, and adherence to regulations.
Innovation Leader for Johnson & Johnson focusing on clinical trial innovation and project execution. Collaborating with multidisciplinary teams to enhance patient experiences and operational efficiency.
Clinical Operations Manager at Johnson & Johnson developing strategies and managing clinical trials with cross - functional collaboration. Responsible for driving innovation and supporting healthcare solutions.