Senior Clinical Trial Specialist
An opportunity to take on the Regional Operations Lead role has become available in the UK. This is a contracted role as a Senior Clinical Trial Specialist. You will lead responsibilities include managing issues and opportunities that impact regional study timeline, quality and budget; overseeing the CLO team, vendors and CRO for the study in the region; and escalating regional decisions, issues and risks to the Study Operations Lead.
- Drive day-to-day management of assigned vendors Communicate study performance expectations to vendors, manage and track vendor performance metrics at a study level
- Develop country/sites specific ICFs
- Manage activities related to Startup as delegated by the SOL Develop study specific documentation as delegated by the SOL Contribute to the management of country and site feasibility assessment
- Contribute to the management of confidentiality agreement execution, budget and contract negotiation with selected sites in collaboration with Legal and Business Operations Provide support in the management of Regulatory document collection and tracking for sites participating to studies
- Contribute, as required, to the management of Institutional Review Board/Ethics Committee (IRB/EC) related activities from submission to approval
- Prepare site staff/CRO training and investigator meeting materials, and present at investigator meetings as assigned
- Manage and track vendor adherence to SOW and oversight plan for assigned vendors Lead protocol deviation meetings, if assigned
- Contribute to or be responsible for the development of vendor specific timelines ensuring alignment with study level timelines
- Manage Change Order and Change Negotiation Form (of vendors) processes, in collaboration with Business Operations as delegated by SOL/ROL/SETL
- Review and approve invoices for assigned vendors Ensure investigator payment: site setup, pass-through processing, visit payment processing and funding processing
Skills and Requirements
- Over 5 years clinical study management experience within Pharma or Biotech is required.
- Strong vendor management experience is required.
- CRA background and experience in co-monitoring highly desirable
- Experience in highly complex therapy areas preferred.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.