Clinical Trial Site Engagement Manager

• Provide operational expertise to sites throughout the clinical trial lifecycle
• Support the clinical trial team to collect site feasibility information and conduct remote site qualification visits
• 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
• Be a point of contact for the sites and a conduit to the clinical trials team at Biocomposites and the CRO supporting the trial
• Conduct thorough feasibility assessment to evaluate the suitability of clinical trial sites
• Collaborate with site investigators and study teams to gather necessary information and assess site capabilities
• Support site initiation visits and collating essential documentation for site activation
• Support sites with protocol specific queries and product/protocol training as required
• Characterize and understand the attributes of a good clinical site versus a poor performing site
• Establish and maintain relationships with the team at clinical trials sites, to maximise performance and engagement during conduct of clinical trials
• Create a process for sites to provide feedback on things like the participant journey, trial operational feasibility, protocol feedback
• Engage, evaluate, and develop a network of high-performing sites through coordinated, consistent interactions using multiple communication channels
• Provide site related feedback during the selection and qualification of new clinical trial sites
• Serve as a centralized source of knowledge regarding clinical trial site feedback and incorporates that feedback, where appropriate, on future trials
• Travel to sites on an on-going basis to establish and maintain strong working relationships
• Attend key scientific congresses and conferences 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
• Link with key stakeholders to ensure smooth delivery of ongoing trials
• Proactively work to 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 them to the respective study Clinical Trial Manager and Clinical Research Director
• Identify efficiencies, best practices and lessons learnt and ensure they are shared across trials/indications to facilitate future studies
• Search for and embrace innovation
• May be asked to provide input to the clinical development strategy/plan
• Participate in workstreams and provide input to procedures/Standard Operating Procedures/Work Instructions and related documents

• Bachelor's degree in a scientific/health related discipline
• A minimum of 5 years of experience in the clinical trials Pharmaceutical, Biotechnology, or CRO industry
• Proven track record of success in a clinical trial environment
• Good working knowledge of IHC-GCP guidelines
• Experience in clinical trial operations
• Strong planning and tracking skills, customer focused, well organized, detail oriented and capable of successfully managing multiple projects
• Excellent time and self-management skills
• Strong project management skills
• Team orientation: initiative to solve problems and improve efficiency
• Proficiency in MS Excel, PowerPoint and Word. MS Project
• Ability to quickly understand complex information
• Able to contribute to clinical development plans
• Understand the healthcare landscape, patient pathways and investigative sites
• Excellent communication and presentation skills
• Able to manage relationships of multiple stakeholders
• Ability to overcome challenges, remove barriers, and influence outcomes
• Experience with tools/systems for managing clinical studies
• Ability to travel to trial sites as required

Experience communicating complex information to healthcare professionals

• Competitive salary package and benefits
• Opportunities to thrive and grow
• Engaged and inclusive global teams
• Team spirit & engagement