Clinical Operations Lead
Clinical Operations Lead
Posted on :
15-03-2025
Employer Active
1 Vacancy
The job posting is outdated and position may be filled
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
Responsible for the clinical operations of a project within a defined regional/global level. Provides oversight of project deliverables assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan Protocol Good Clinical Practice (GCP) ICH guidelines and local regulations. The COL acts as a primary liaison between the CRAs and the clinical project team. Additional responsibilities include project specific training of CRAs conducting assessment visits with CRAs implementation of enrollment and recruitment strategies preparation of the monitoring plan and other structural documentation and the oversight of monitoring visit scheduling site and monitoring performance metrics issue escalation and corrective actions. The COL will develop study tools for site and CRA use review visit reports review and track protocol deviations and support other objectives for clinical operations and the clinical project team.
Project Oversight
- Overall oversight of (a group of) regional CRAs to ensure (site) compliance with study protocol study plans ICHGCP local regulations and study timelines.
- Monitoring support visits (Comonitoring) 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 oversight of study deliverables related to other departments (e.g. Data Management TMF Operations etc.
- Oversee regional startup and feasibility activities.
- Assist in vendor management activities as required per project.
- Perform review of visit reports for quality compliance and appropriate site management.
- Assure compliance with high quality and timely 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 progress.
- Contribute to financial project management processes as applicable. May include but may not be limited to input on revenue recognition site payments and site passthrough expense review.
- May be required to manage/oversee investigator sites including CRA responsibilities on a temporary or permanent basis.
Project Liaison
- Conduct regular global CRA calls with the monitoring and site management team as well as individual/country CRA calls
- Attend meetings with Study Sponsor to provide status updates on country and site progress
- Provide operational support and guidance to the monitoring team throughout project.
- Provide 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 point of contact for regional CRAs for studyspecific 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 visits per departmental requirements to assess the performance of the CRA against their monitoring responsibilities.
Study Documents and Plans
- Develop training materials and study tools for sites and CRAs including monitoring plans.
- Develop and implement enrolment and recruitment strategies together with clinical project team.
- Develop presentation materials for and presents at Sponsor Kickoff meetings Investigator meetings and Sponsor Calls (as needed) and prepares presentations for Site Qualification Visits and Site Initiation Visits.
Qualifications
- College diploma/degree AND 79 years related experience continuous training and knowledge/skills upgrading
- Undergraduate university degree (Bachelors or Honors Bachelors) AND 46 years experience substantial ongoing jobrelated training
OR
Other
- Health Sciences Life Sciences or Nursing specialty preferred or SoCRA and/or ACRP Certification/Designation.
- Should have a minimum of 3 years CRA experience have strong experience with EDC systems be proficient with MS Office have strong written and verbal communication skills and highly effective interpersonal and organizational skills.
- Demonstrate the following attributes: proactive detail oriented taskdriven and highly organized.
- Demonstrate the critical elements 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.
Working Conditions
- Homebased
Accommodations for persons with disabilities are available on request in respect of all aspects of the recruitment and selection lifecycle. Requests can be directed to
PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams leveraging various methods of attack via email text voice and social media. Please note that Alimentiv only uses company email addresses which contain @alimentiv to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv please verify the domain of the senders email address and that they are asking you to apply on this website. If you believe youve been a victim of a phishing scam please contact your local government cyber authority to report.
Employment Type
Full-Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
