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Position Summary:
The Site Management Lead is the regional representative of our Client for coordinating operational aspects of clinical studies, supporting study teams with activities from startup, recruitment, database lock to close out, fulfilling sponsor oversight activities, and maintaining site relations and site staff engagement. They are responsible for development and management of clinical sites being considered and/or participating in clinical trials, including site feasibility, study enrollment in accordance with the enrolment plan, issue management, delivery of database locks, monitoring oversight and inspection readiness at all times for assigned sites, and improving the overall experience of sites and site staff by developing and executing site engagement, communication and support strategies.
Key Responsibilities
- Communicate directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out, driving a superior customer experience
- Apply regional expertise to oversee investigator site start-up activities to ensure timelines are met, including site identification and qualification, collection and submission of regulatory documents, customization and negotiation of informed consent documents, serve as the point of contact for review of IRB/EC submissions (ensuring country specific requirements are incorporated, where applicable), facilitate negotiation and execution of clinical trial agreements, site training and participate in site initiation visits
- Identify potential opportunities to accelerate clinical trial enrollment and effectively drive timelines aligned with company priorities
- Support delivery of database locks per forecasted timelines and site close out
- Serve as a key member of the Clinical Study Team and oversee site monitoring activities at clinical trial sites as performed by a Contract Research Organization (CRO) or internally for all programs (monitoring oversight), including identification, mitigation and escalation of significant findings and trends at a site and country level
- Conduct onsite and remote monitoring oversight visits to evaluate CRA site monitoring performance; communicate trends and significant findings with the CRO and the trial team(s)
- Responsible for monitoring site and country level metrics to proactively identify risks/issues and propose mitigations
- Generate, utilize, and oversee metrics and tools to ensure the site monitoring activities are conducted in accordance with applicable regulations, SOPs, and trial objectives
- Serve as an effective communication bridge between sites, vendors and trial management team
- Collaborate with cross-functional internal and external study teams to remove barriers to trial execution at a site and/or country level
- Establish and develop strong professional relationships with clinical investigators, study coordinators and other site staff to expand/maintain clinical research partnership opportunities and optimize delivery of clinical trials
- Support identification and development of clinical research naïve sites, through training and supporting development of processes to conduct clinical research
- Create institutional knowledge and libraries of country specific requirements for future reference
- Additional local responsibilities as required and appropriate for the local region
- Frequent travel in assigned regions, with up to 50% or higher domestic and/or international travel
Key Skills, Abilities, and Competencies
- Strong understanding and knowledge of regional clinical research landscape, guidelines and regulations
- Strong verbal and written communication skills
- Demonstrated interpersonal skillset necessary to guide and maintain internal and external collaborator relationships
- Challenge the norm with creative solutions
- Ability to work in a fast-paced environment
- Ability to prioritize and manage multiple competing tasks and demands while ensuring overall quality and integrity
- Foster open and transparent communication
- Demonstrated ability to effectively influence and implement change and continuous improvement
- Collaborate effectively in a dynamic, cross-functional matrix environment
Requirements
Education, Registration &/Or Certifications:
- Bachelor’s degree or equivalent in Science/Health Care related field; advanced degree preferred but not required
Experience
- 6+ years of experience in a clinical monitoring role (field monitoring experience required) or equivalent.
- 3+ years’ experience in a lead clinical monitoring or CRA manager role, project/trial management position, or equivalent
- Experience in a monitoring oversight role preferred
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