Job Type: Permanent
Specialism: Administration Clinical Trial Operations Communication
Industry: CRO & Clinical Operations
Salary: $100000 - $120000
Location: USA
ClinicalPro is seeking a Senior Clinical Trial Manager for a leading CRO located in the USA.
This individual will be responsible to carry out activities and guarantee that trials are of high quality.
Must be eligible to work in the USA.
Responsibilities
- Responsible for representing clinical operations (ClinOps) in operational vendor, CRO, and cross-functional research team meetings and ensuring adherence to international operational standards and guidelines.
- Ensure that ClinOps-related issues.
- Counsel the management team on any prospective difficulties and fixes.
- Accountable for the review and direction of all operational activities.
- Accountable for ensuring that all elements of the trial master file for investigational studies allocated correct and up to date.
- Keep track of foreign industry practices for operational effectiveness and compliance via global regulatory information.
- In charge of operational advice for researchers and CRO training related to study conduct.
- Reviewing study finances.
- Handling complaints made by CROs or other service providers and managing CROs’ requests for clinical studies.
- Participate in audits and assist with regulatory inspections pertaining to GCP.
- Ensure the evaluation of clinical data consistently.
- Participate in the creation of ClinOps SOPs and corporate policies to guarantee adherence to local regulatory standards and promote ongoing improvement.
- Join cross-functional teams and represent clinical operations.
- Support clinical research and development initiatives.
Skills and Requirements
- A bachelor’s degree in science or medicine is necessary.
- Working with CROs and other suppliers, with a minimum of five to ten years of expertise in clinical operations.
- Experience in a clinical research setting for five years.
- Experience in the past working in a cross-functional setting.
- Experience building connections with CROs and external vendors that have been successful in the past.
- Excellent verbal communication abilities led to the professional communication and direction of individual and group activities connected to clinical operations.
- Knowledge of Microsoft software.
- Knowledge in coding, and data mining techniques.
- Travelling to local and international destinations.
- A benefit would be prior experience working in a startup setting.
Apply
If you’re interested in this position, apply now to send us an updated copy of your CV, or give us a call right away.
To explore more opportunities, visit Opportunities at ClinicalPro