Clinical Trial Lead - Manchester, United Kingdom - OrciTrials

Description

• Remote

• Reviews/creates/tracks trial newsletters, memos, mass correspondence etc
• Oversee the conduct of monitoring/comonitoring activities for site initiation visits, interim site monitoring, and closeout visits, in conformance to all relevant laws, regulations, guidelines, protocol, and internal SOPs/policies.
• Ensure the monitors are adequately trained on the therapeutic area and study and are prepared to train the site staff during the Site Initiation Visit (SIV) and at other times to trialspecific industry standards
• Identifies site findings with the ability to retrain, place corrective action in place with the site, and followup as required.
• Develop and monitor metrics to evaluate the monitor and site performance (trip report tracking, days on site needed, etc). In the event of performance concerns, evaluate cause and mitigate risk to the study.
• Comonitor as required to provide coaching and manage performance of CRAs.
• Prepare study documents
• Assists in evaluation of vendor performance during conduct of the study.
• Maintains clinical trial tracking information pertaining to the study
• Assists with audit/inspection responses.
• Prepares key reports and documents on progress of study for client or internal project manager as appropriate.

• University/college degree (life sciences preferred) or certification in a related field
• A minimum of 57 years of field monitoring experience (e.g., independent monitoring, comonitoring, accompanied site visits).
• A minimum of 23 years Lead CRA experience.
• Good knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs.
• Good knowledge of therapeutic area assigned.
• Strong knowledge of FDA regulations and ICH GCP guidelines
• Excellent verbal and written communication skills; excellent interpersonal and organizational skills with demonstrated attention to detail.
• Familiarity with video and audio tools such as ZOOM, WebEx, GoTo Meeting, Teams, etc.
• Experience using SharePoint site as a way of managing and organizing documents and work for the role and for the CRA team
• Ability and willingness to travel up to 30%as needed.