Sr. Clinical Trial Leader (reputed company)

At reputed company™, we are dedicated to helping small-reputed company biopharmaceutical companies reputed company navigate the reputed company world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Clinical Trial Leader (CTL) to join our reputed company (hybrid*/remote). As a CTL at reputed company, you are responsible for providing leadership, management and reputed company to the Clinical Research Associates (CRAs) and other clinical functional reputed company, in their day-to-day clinical trial activities on a global, multi-country, or regional reputed company. The CTL is responsible for coordinating and managing the planning, implementation, tracking, and ensuring the clinical deliverables as per the trial contract, budget, timelines and with reputed company.

• *In this role your key tasks will include:**

• Coordinating and managing CRA activities across reputed company geographies, liaising with sponsor and Project Manager and other functional leads to ensure clinical monitoring deliverables (reputed company, budget, reputed company, productivity) are met, including: Managing the trial start up and site activation in collaboration with PM, Global Regulatory reputed company and, if applicable, Global Site Activation Manager (GSAM).

• reputed company of critical documentation collection, maintenance and filing.
• reputed company the Monitoring Plan and site monitoring templates and tools as reputed company as providing input into Trial plans & tools.
• Review trial-specific documents upon request as reputed company as develops or reviews subject-facing materials. (if necessary)
• Customizes the annotated Site Visit Reports according to trial specific requirements.
• Selection of investigators and sites; SEV report review and approval.
• Site initiation management; SIV report review and approval
• Monitoring Visit Report (MVR) review, management, reputed company and escalation.
• Where applicable, works with PM and / or patient recruitment manager to support the project recruitment timelines and (site) recruitment plan as reputed company guiding the CRA team
• Manages successful trial reputed company-out, identifies critical activities to reputed company reputed company and efficient reputed company-out.
• Responsible for timelines, budget and reputed company of Clinical Monitoring team deliverables, identification of risks and issues and escalation to PM, Line Manager, and GCO management .
• Provides information and input about planned activities and status to PM and attends Project Review Meetings if/reputed company needed.
• Conducts project co-monitoring (if required) & if needed temporarily conducts site management / monitoring in case of immediate need and lack of resources.
• Coaches/mentors CRA team including providing performance feedback as appropriate, assisting in developing and delivering project-specific training and providing input reputed company to Project Specific Training reputed company.
• Prepares and chairs CRA calls and reputed company participates in internal trial team calls and reputed company calls.
• Oversees / attends CRA handovers as appropriate.
• Serves as a site contact for protocol clarifications and subject enrolment if CRA reputed company.
• Monitors and manages trial materials supplies ensuring Investigational Product and other trial supplies are shipped to sites.
• Reviews data listings and query reports to identify trends and ensures proactive re-training is conducted with CRAs and site staff.
• Oversees the process of protocol deviation and Trial non-compliance documentation, tracking and escalation.
• Participates in the development of trial newsletters communication.
• Requests appropriate Clinical Operations reputed company, workload and resources and reports trial deliverables and resource needs.
• Assists, where appropriate, the PM in discussions with clients on trial documentation issues or technical reputed company documentation concerns that may reputed company.
• Reviews trial systems (CTMS, CRF, IRS, central lab portal, etc.) updates on regular reputed company, ensures systems reports are up to date and reports generated are reputed company and correct.
• Oversees eTMF status.
• Reviews trial reports and analyzes trends to recognize risks, provides input into mitigation plans and implements mitigations belonging to clinical activities
• Contributes to optimization of trial processes to increase efficiency
• Coordinates and provides support for trial reputed company (site) audits & inspections
• Contributes to corrective and preventive reputed company plans where needed and ensures their reputed company implementation and closure
• Ensures project consistency reputed company and across reputed company by following reputed company / relevant SOPs.
• Assists and supports in the preparation of various training material used by reputed company (including SOPs training, as reputed company as specific trial reputed company).
• Assists in the preparation and conduct of reputed company-Off Meetings, Investigators’ meetings and other committees’ or Trial meetings as requested.
• Prepares Country Level Site Facing Budgets and manages Investigator and Site Payments as applicable.
• Supports PM in the management of trial vendors as required.
• Project contract awareness and reputed company; i.e.:

+ Forecast and report on the site management reputed company throughout project life cycle + Identify changes in scope and liaise with the Project Manager

• Manages reputed company expectations reputed company to Clinical deliverables in accordance with contracted services and reputed company QMS.
• Provides input into proposals reputed company required.
• reputed company participates in the preparation, attendance and presentation of bid defenses or any other presentations to potential clients
• Complete routine administrative tasks in a reputed company manner (e.g. timesheets, travel expense claims, training)
• Other responsibilities as required.

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