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The Clinical Team Leader (CTL) serves as the clinical functional lead, accountable for the clinical monitoring/site management delivery of assigned study (ies). Responsible for the planning, conduct, and oversight of assigned Clinical Research Associate/Clinical Monitoring Associate (CRA/CMA) operational study team and site management study activities to ensure clinical study and site deliverables are met with quality and timeliness. May provide administrative line management, which includes oversight of training, compliance, performance and career management, and development of direct reports. Provides metrics to the project team to demonstrate current and planned status of the study.
Line management responsibilities for staff members: may participate and direct activities related to department staff operations such as interviewing and selection, training compliance, professional development, performance management, and employee counseling and separations. Approves courses of action on salary administration, interviewing and selection, terminations, professional development, performance appraisals, job description preparation, and employee counseling. Works with and advises staff on administrative policies and procedures, technical problems, priorities and methods.
Evaluates and reports direct report workload forecasts and trends to ensure proper resource allocation. Reviews CRA metrics and ensures targets are understood and met.
Evaluates staff’s competency to perform visits/site contact independently via sign-off visits and Performance Assessment Visits (PAVs) according to company standards and process.
Collaborates with study leadership/management to identify project resourcing demands, resolving potential resourcing conflicts and facilitating mutually beneficial resolutions.
Responsible for team member clinical/site management study deliverables as the clinical functional team leader. Drives and manages the clinical and site management aspects of assigned study during all study Trusted Process phases. May be a standalone lead or part of a regional or global clinical functional lead team. Develops and maintains study clinical plans, guidelines and tools, including the Clinical Monitoring Plan (CMP). Manages compliance to the monitoring strategy agreed with the Sponsor and outlined within the budget and study contractual agreement, including any requirements of monitoring driven by Strategic Data Management (SDM). Reviews the study scope of work, budget and protocol content and ensures the clinical study team (CRAs/CMAs) is aware of the parameters. Escalates to the PM any clinical/site management deliverables (timeline, quality, and budget) at risk, and any activities and requests which are out of contracted scope.
Attends and presents monitoring/site management status during routine sponsor meetings (teleconferences and face to face). Understands the monitoring strategy required for the study and participates in the development of the study risk assessment plan. Is accountable for the clinical teams understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP, and risk plans.
Provides development and delivery of initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study. Plans and leads regular clinical study team calls to provide status updates, ongoing training and accountability to deliverables.
Routinely reviews Clinical Trial Management System (CTMS), Case Report Form (CRF), drug management, safety, Trial Master File (TMF), IVRS/IWRS enrollment, Strategic Data Monitoring (SDM) and/or other dashboards to oversee site and study team conduct, to ensure timely entry of all operational aspects (required visits, duration, and frequency) according to plan, and to oversee site and study team conduct and identify any risks to delivery or quality.
Reviews the content and quality of site monitoring documentation (site monitoring calls, site visit reports, site letters, and pertinent correspondence), to ensure they represent site management activities and conduct. Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines.
Supports site selection process, following company process for site ID and feasibility.
Tracks and evaluates components required for site initiation scheduling and conduct, and prompts proactive planning. Is accountable to proactively plan and directly collaborate with other functional leads (SSU and site contracts) and the clinical team members to ensure timely site initiation, and site activation timeline maintenance at the regional or study level.
Tracks and evaluates components required for effective and timely SDV and data flow, reviewing status of site and study eCRF entry, SDV, triggered monitoring conduct, query response, and data cleanliness. Proactively collaborates with data management functional lead to plan towards data cut and lock deadlines. Develops and executes corrective action plans at site and study level to address any issues.
Collaborates with other functions to ensure site compliance and delivery according to protocol, ICH/GCP and country regulations, including medical monitoring, Safety, QA.
Assists with clinical listing reviews.
Represents the clinical team and site management functional activities at Trusted Process and sponsor meetings. Attends and presents at Kick-off, Quick Start Meetings and Investigator Meetings. Prepares and presents Site management/Clinical monitoring materials for bid defense meetings.
Reviews and oversees the protocol deviation trends identified by the clinical monitoring team. Ensures team follows process for documentation of protocol questions and deviations.
Ensures ongoing essential document collection, TMF maintenance and quality of content for assigned areas.
BA/BS degree in the science/health care field or nursing degree, or equivalent combined education and experience. Moderate independent field monitoring experience. Minimal lead monitoring or comparable supervisory experience. Extensive understanding of SOPs, Work Instructions (WI), FDA, and local regulations as well as ICH GCP guidelines, and an advanced understanding and application of applicable therapeutic standards. Ability to apply problem solving techniques to resolve complex issues at investigator sites and within study, and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research study at an investigator site. Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues. Strong organizational, documentation, and interpersonal skills as well as a willingness to work within a team-oriented environment. Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), e-mail, and voicemail. Effective command of written and spoken local language, if not English, as well as English. Ability to handle multiple tasks to meet deadlines in a dynamic environment. Must have valid, current driver's license and ability to secure corporate credit card. ACRP CCRA or equivalent certification/credentials strongly preferred.
Internal Number: 18001841
About Syneos Health
Why Syneos Health? Join a game-changing global company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies - INC Research and inVentiv Health - we bring together more than 21,000 clinical and commercial minds to create better, smarter, faster ways to get biopharmaceutical therapies to patients. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment where you'll be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. Grow your career with a global company committed to shortening the distance from lab to life.