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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 experienceApply 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 visitsIdentify potential opportunities to accelerate clinical trial enrollment and effectively drive timelines aligned with company prioritiesSupport delivery of database locks per forecasted timelines and site close outServe 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 levelConduct 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 mitigationsGenerate, utilize, and oversee metrics and tools to ensure the site monitoring activities are conducted in accordance with applicable regulations, SOPs, and trial objectivesServe as an effective communication bridge between sites, vendors and trial management teamCollaborate with cross-functional internal and external study teams to remove barriers to trial execution at a site and/or country levelEstablish 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 trialsSupport identification and development of clinical research naïve sites, through training and supporting development of processes to conduct clinical researchCreate institutional knowledge and libraries of country specific requirements for future referenceAdditional local responsibilities as required and appropriate for the local regionFrequent 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 regulationsStrong verbal and written communication skillsDemonstrated interpersonal skillset necessary to guide and maintain internal and external collaborator relationshipsChallenge the norm with creative solutionsAbility to work in a fast-paced environmentAbility to prioritize and manage multiple competing tasks and demands while ensuring overall quality and integrityFoster open and transparent communicationDemonstrated ability to effectively influence and implement change and continuous improvementCollaborate 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 equivalentExperience in a monitoring oversight role preferred P1424491BOSJL_1753898317 To Apply for this Job Click Here