Clinical Trial Site Engagement Manager

Biocomposites; Wilmington (NC); Remote; USD 100,000 - 150,000; Full time

Benefits offered by this job

Competitive compensation

Benefits package

Remote work option

Job summary

Biocomposites is seeking a Clinical Trial Site Engagement Manager to provide operational expertise across the clinical trial lifecycle. You will support site feasibility data collection, remote site qualification visits, and implement engagement strategies to identify challenges and help sites deliver trials on time.

The role requires remote work with occasional site travel (35 hours per week) and close collaboration with the CRO and clinical trials team to ensure high-quality conduct and

Qualifications

• Bachelor's degree in a scientific/health related discipline.
• 5+ years of experience in the clinical trials Pharmaceutical, Biotechnology, or CRO industry.
• Good working knowledge of ICH-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.
• Ability to quickly understand complex information (experience communicating complex information to healthcare professionals, preferred).
• 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.

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 team to 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 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

Skills

Clinical trial operations

Site engagement

Project management

Communication

Relationship management

Education

Bachelor's degree in a scientific/health related discipline

Tools

MS Excel

PowerPoint

Word

MS Project

Job description

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 willprovide operational expertise to sitesthroughout 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

Remotewith 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 relationswith 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 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

Essential requirements

• Bachelor's degree in a scientific/health related disciplne
• 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 MSExcel, PowerPoint and Word. MS Project
• Ability to quickly understand complex information (experience communicating complex information to healthcare professionals, preferred)
• 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

What do we offer?

Competitive salary and benefits!With us, you will receive a competitive salary package and benefits.

We grow talent.At Biocomposites we create opportunities to thrive and grow.

One Biocomposites – team spirit & engagement.Our culture is important and we strive to create engaged and inclusive global teams that encourage colleagues to share their diverse perspectives and opinions.

Who do we look for?

People who are passionate about what we do.

People who are open minded to evolving the way we work.

People who can work together to transform outcomes and change lives.