Clinical Trial Site Engagement Manager

Job Description

Biocomposites is an international medical devices company that engineers, manufactures, and markets world leading products for use in infection management in bone and soft tissue. Based in Keele, UK, it has global operations across Europe, USA, Argentina, Canada, China, and India. Biocomposites is a world leader in the development of innovative calcium compounds and bone cements for surgical use. Its products regenerate bone and target infection risks across a variety of specialties, including musculoskeletal infection, orthopaedics, trauma, spine, foot and ankle, podiatry, and sports injuries.

Biocomposites products are now used in over one million procedures per annum and sold in more than 100 countries around the world.

The role

As a Clinical Trial Site Engagement Manager, you will provide operational expertise to sites throughout the clinical trial lifecycle.

The rolewill be involved in supporting the clinical trial team to collect site feasibility information and conduct remote site qualification visits; will help implement strategies for engaging clinical trial sites and investigators to identify challenges and supporting sites to overcome them to ensure timely delivery of trials; and willbe a point of contact for the sites and a conduit to the clinical trials team at Biocomposites and the CRO supporting the trial.

Location & Working pattern

Remote with availability to commute when required (35 hpw).

Duties& Responsibilities

• Conduct thorough feasibility assessment to evaluate the suitability of clinical trial sites (site feasibility questionnaires).
• Collaborate with site investigators and gather necessary information. Assess site capabilities.
• Support site initiation visits and site activation.
  
  Support sites with protocol specific queries and product/protocol training.
• Characterize and understand the attributes of a good clinical site.
• Establish relations with clinical trials sites teamsto maximise performance and engagement during clinical trials
• Create a process for sites to provide feedback (participant journey, trial operational feasibility, protocol feedback)
• Engage, evaluate, and develop a network of high-performing sites
• Provide site related feedback during the selection and qualification of new trial sites.
• Serve as point of contact regarding clinical trial site feedback. Incorporates that feedback on future trials.
• Travel to sites to establish and maintain strong working relations.
• Attend key scientific events to manage site-related interactions and sessions to enhance knowledge in therapeutic areas.
• Liaising with site regarding contracting timelines and preventing unnecessary delays
• Monitoring site performance and anticipated recruitment rate
• Fully understand all matters that impact the successful patient recruitment and high-quality conduct of the clinical trial at each site
• Ensure a supportive relationship with clinical sites and trial personnel.
• Proactively work to fully understand the patient voice, preferences and pathways.
• May participate in monitoring oversight activities such as accompanying the CRO Clinica Research Associate during site visits to help ensure high quality conduct and execution of the clinical trials according to the protocol and ICH GCP and local regulatory requirements.
• Work together with the Medical Science Liaison team to ensure optimal synergies in the respective site contacts and support.
• Optimize site engagement for a specific trial to ensure site engagement and quality for the site-level enrolment and execution of every trial.
• Oversee and track patient recruitment for the regional sites and proactively identify ways to prevent recruitment delays
• Pro-actively identify issues and look for solutions in the assigned clinical trial and timely escalate…