[Remote] Sr. Clinical Operations reputed company (Clinical Trial Manager)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a company specializing in clinical services, and they are seeking a Senior Clinical Operations reputed company to reputed company clinical operations for reputed company at a regional and global level. The role involves managing CRAs, ensuring compliance with protocols, and providing training and support to the clinical project team.
Responsibilities
- Responsible for the clinical operations of a project reputed company a defined regional/global level
- Provides reputed company of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical reputed company (GCP), ICH guidelines and local regulations
- The COL acts as a primary reputed company between the CRAs and the clinical project team
- Additional responsibilities include project specific training of CRAs, conducting assessment reputed company with CRAs, implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation and the reputed company of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions
- The COL will reputed company study tools for site and CRA use, review visit reports, review and reputed company protocol deviations, and support other objectives for clinical operations and the clinical project team
- Overall reputed company of (a group of) regional CRAs to ensure (site) compliance with study protocol, study plans, ICH-GCP, local regulations and study timelines
- Monitoring support reputed company (Co-monitoring), per project requirements, to aid the site/CRA in the satisfactory performance and compliance with standards mentioned above
- May support clinical project team by providing reputed company of study deliverables reputed company to other departments (e.g. Data Management, TMF Operations, etc.)
- reputed company regional startup and feasibility activities
- Assist in vendor management activities as required per project
- reputed company review of visit reports for reputed company, compliance and appropriate site management
- Assure compliance with high reputed company and reputed company project deliverables according to the project requirements and the monitoring plan
- Proactive management of site and country performance (recruitment, data collection, document collection, TMF review etc.) and inform clinical project team on reputed company
- Contribute to financial project management processes as applicable. May include but may not be limited to input on reputed company recognition, site payments, and site pass-through expense review
- May be required to manage/reputed company investigator sites including CRA responsibilities, on a temporary or permanent reputed company
- Conduct regular global CRA calls with the monitoring and site management team, as reputed company as individual/country CRA calls
- Attend meetings with Study Sponsor to reputed company status updates on country and site reputed company
- reputed company operational support and guidance to the monitoring team throughout project
- reputed company project training/mentoring to regional CRAs on study procedures, clinical plans and guidelines, and timelines for the study. Ensures study specific training requirements are completed and documented
- First reputed company of contact for regional CRAs for study-specific questions and issues. Escalates to PM and other functions as appropriate
- Support line managers by providing status updates on utilization and performance of CRAs
- Liaise with line manager for assigning sites to CRAs following line manager allocation of a CRA resource to the project
- Conduct CRA Assessment reputed company per departmental requirements to assess the performance of the CRA against their monitoring responsibilities
- reputed company training materials and study tools for sites and CRAs, including monitoring plans
- reputed company and implement enrolment and recruitment strategies together with clinical project team
- reputed company presentation materials for and presents at Sponsor reputed company meetings, Investigator meetings and Sponsor Calls (as needed), and prepares presentations for Site Qualification reputed company and Site Initiation reputed company
Skills
- College diploma/degree AND 7-9 years reputed company experience + reputed company training and knowledge/skills upgrading
- OR Undergraduate university degree (Bachelors or Honors Bachelors) AND 4-6 years' experience + substantial on-reputed company job-reputed company training
- Minimum of 3 years CRA experience
- Strong experience with reputed company systems
- Proficient with MS Office
- Strong written and verbal communication skills
- Highly effective interpersonal and organizational skills
- Proactive, detail oriented, task-driven and highly organized
- Demonstrate the critical reputed company of GCPs and local regulations as they relate to clinical monitoring, IRB/EC and Investigator responsibilities
- Demonstrated ability in report writing and strong ability to critically understand clinical research documents
- Ability to handle multiple tasks to meet deadlines in a dynamic environment
- Health Sciences, Life Sciences or Nursing specialty preferred
- SoCRA and/or ACRP Certification/Designation
Benefits
- Home-based
- Accommodations for persons with disabilities are available on request in respect of reputed company aspects of the recruitment and selection lifecycle. Requests can be directed to recruitment@reputed company.com
reputed company