Are you an experienced CRA with people management skills and want to manage a group of CRAs in the world of Medical Devices? Don't hesitate and apply today!
Job Description
As a CRA Oversight Manager, part of the clinical research team, you will be overseeing a group of CRAs spread over multiple countries to ensure the correct execution of clinical studies in the area of neurovascular or peripheral vascular therapies.
Responsibilities
- Supervising a team of CRAs located in different EU countries.
- Supporting the team with the planning/execution of monitoring visits.
- Review and finalize all documentation linked to on-site monitoring or remote monitoring activities such as but not limited to Site Qualification Visit, Site Imitation Visit, Interim Monitoring Visit along with their Confirmation and Follow Up Letters,…
- Assist Clinical team with the development, approval, and distribution of study-related documents including Case Report Forms (CRF's), informed consent templates, study protocols, study manuals, and other study tools to investigational sites and ethics committees.
- Assist Clinical management and Clinical Trial Coordinator Team with the development, negotiation, and execution of the site contract, budget, and payment plan.
- Provide oversight on, or perform device accountability, inventory, and distribution, device complaint/malfunction processing and tracking.
- Participate in the distribution, collection and tracking of regulatory documentation to ensure compliance at both the sites and Penumbra central file, and for audit readiness.
- Provide mentoring to junior staff regarding protocols, site management/monitoring, etc.
- Assist Clinical management with regulatory submissions, and other reports as required.
- Perform regular co-monitoring visit with each of the field CRA, to assess the quality of the work done as well as a training/coaching opportunity.
- Proactively identify issues/roadblocks in the management of the study, asses them and propose solutions to Study Manager and other Cross Functional Departments.
- Proactively communicate potential or actual delays and propose actions to ensure that project timelines are met. Participate in audits.
- Review the data base on an ongoing basis to ensure it is up to date and ensure it is data snap ready at all time.
- Support centralized/remote monitoring activities as assigned in the Core Team.
- Support external CRA team with clinical systems management, site management activities, quality readiness plan tasks, and data logic and consistency checks.
- Provide support to Study Management to establish and implement standard processes around clinical trial management.
- Provide periodic updates to management regarding site start-up, enrollment, and closeout activities.
- Adhere to the Company's Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
- Ensure other members of the department follow the QMS, regulations, standards, and procedures.
- May monitor corrective actions through completion as well as provide progress updates to management.
- Perform other duties/projects as required and assigned.
- Availability for travelling up to 20%.
Requirements
- Bachelor or Master degree.
- Business English, any other EU language is a plus.
- Min 5 years of CRA experience.
- People management experience is preferred.
- Medical Devices experience is a plus.
- Excellent verbal, written, and interpersonal communication skills.
- Strong organizational and problem-solving skills.
- Keen attention to detail.
- Ability to work in teams and with multiple projects.
- Ability to provide guidance and mentoring to junior Clinical staff.
- Proactiveness.
- High level of competence in Word, Excel, PowerPoint, or equivalent programs.
- Existing right to work in Europe required.
Information
- Long term project.
- Payroll / Freelance.
- 0.8 to 1.0 FTE.
- Remote with ad-hoc travel for co-monitoring visits (max 20%).
