Clinical Lead

The Clinical Lead position is responsible for the management of assigned
clinical trials with a focus on investigational site management and monitoring
activities. The Clinical Lead will ensure that site management and monitoring
aspects of clinical trials are executed in accordance with applicable
regulations and that the quality of clinical data generated from clinical trials
meets the requirements for Regulatory Authority approval. This position
provides strategic and tactical operational planning and execution of site
management and monitoring activities for assigned trials.

Essential Functions:

• Oversight and management of the investigator site management and monitoring activities and the clinical monitoring teams for the assigned studies during the startup, execution, and close out phase of the study.
• Functions as the lead site management resource for the client, investigational site, and the internal study team.
• Ensures all monitoring activities for assigned projects are conducted according to study plans, relevant processes, and standard operating procedures (SOPs), GCP/ICH guidelines and other applicable regulations.
• Provides input and supports development of study specific training material, and as appropriate provides study-specific training for the assigned clinical monitoring teams.
• Oversees quality of clinical monitoring deliverables to clients and may conduct Quality Co-monitoring visits to ensure data quality and monitoring performance metrics are being met and develop solutions to optimize performance.
• Responsible for the review and approval of study monitors' site visit reports for the investigational sites on assigned studies within appropriate process requirements.
• Works closely with clinical project manager and contributes to development of the clinical study specific plans as assigned. This includes but is not limited to clinical monitoring plan. Also responsible for creating and updating study specific tools and templates related to clinical site management and monitoring.
• Assures compliance with study monitoring plan and collaborates with cross functional teams to ensure timely site initiate process.
• Leads and supports any study specific requirements related to site performance, including but not limited to patient recruitment, site payments, study material needs, etc.
• Works closely with clinical project management team and provides status report for onsite initiations, enrollment, visit schedules, trip report completion and any other status report as per the company and/or project specific requirements.
• Works closely with the clinical project management team and the cross functional teams while keeping them apprised of any issues and seeking guidance as needed.
• Maintains timely and effective communication among team members and site personnel as assigned.
• May be responsible for the supervision and administrative oversight of the direct reports within the company expected framework. The direct report personnel may be clinical research associates (CRAs) or any other clinical team members if deemed appropriate.
• Other duties as assigned

Necessary Skills and Abilities:

• Targeting candidates with significant experience in Rare Disease therapeutic indication.
• Demonstrated ability to perform CRA activities at an advanced level.
• Demonstrated ability to lead a team of Clinical Operations professionals in the successful execution of clinical trials.
• Demonstrated ability to develop and maintain effective relationships with study site personnel and a track record of positively influencing them to achieve study goals.
• Experience managing/mentoring and developing junior staff.
• Experience using Microsoft Office (Word, Excel, Power Point) applications to prepare charts, tables, forms, reports, and presentations.
• Experience in working in eTMF, CTMS, EDC, DCT and overall systems that support conduct of clinical trials.
• Extensive understanding of SOPs, Works Instructions, regional regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
• Excellent verbal and written communication skills; interpersonal and presentation skills are required.