Global Trial Leader

Job description

Job Description

Global Trial Leader (GTL) is accountable for planning, executing and to support reporting on global phase II-IV clinical trials from operational planning through trial close-out, in compliance with Novartis processes, GCP/ICH and regulatory requirements. Major Accountabilities 1. Operationalize protocol • Plan, facilitate and lead the global multidisciplinary Clinical Trial Team (CTT) • Provide direct operational input into protocol development to ensure efficient and effec
1. Operationalize protocol • Plan, facilitate and lead the global multidisciplinary Clinical Trial Team (CTT) • Provide direct operational input into protocol development to ensure efficient and effec-tive delivery of trial objectives • Communicate protocol information including changes or amendments to countries • Create and implement an operational trial plan with line function support and stake-holder management with tracking to plan and updating as required • Execute an operational risk management plan highlighting potential risks and actions. • Foresee resource gaps and escalate in a timely fashion • Create and drive trial level timelines • Ensure all trial deliverables are met (i.e., budget) on time with quality • Provide updates at relevant internal/external (as applicable) boards • Prepare all relevant study related documents required for trial initiation with Clinical Scientist (CS)/Medical Lead and line functions to ensure availability of high quality de-liverables within specified timelines • Develop trial level operational training materials for Clinical Study Manager (CSM), Field Monitor (FM) and sites 2. Manage Trial Allocation and coordination/management of activities leading to initiation of sites • Accountable for assigned trial allocation to ensure optimal patient accessibility, re-source allocation, and country development. • Create site screening tool for country feasibility, obtain approvals at relevant internal boards, and build allocation scenarios based on country feedback • Accountable to write monitoring plan (including any tools and forms) and ensure CSM and medical input • Collaborate with Medical Lead/CS and Integrated Information Sciences (IIS) to ensure relevant data capture tools are created and implemented as documented in data han-dling plan or equivalent document (e.g. CRFs, protocol deviations, questionnaires, di-aries, translations, edit checks) • Plan, drive and facilitate multi-national investigator meetings or equivalent investigator training. 3. Prepare, Implement and Manage Vendors • Accountable for vendor selection with appropriate CTT and outsourcing consultation • Responsible for development of trial specifications (including user acceptance testing) with vendors and appropriate line function input to ensure the capture of quality data as per protocol requirements. • Management of vendor start up, development of data specifications, and oversight of vendor activities and interactions during the trial, including
 Efficient, quality-driven, timely execution of global clinical trials (i.e., best sites selected for a given trial, optimization of study start up, 100% of target enrolment at last patient first treatment, ) in compliance with international and local regulations and Novartis internal standards  Data cleaning process is successfully accomplished within the required timelines across the trial with 100% clean data and no database unlocks  Timely submission and delivery of high quality clinical trial documents to achieve critical milestones  Proactive operational planning with effective contingency and risk mitigation plans  Cost effective management of budget and resources with limited unforeseen cost overru

Desired profile

Bachelor's Degree required; Fluent English (oral and written) • Thorough knowledge of Good Clinical Practice, regulatory processes, and clinical development process. • Demonstrated ability to influence without authority • Project Management experience preferred • >3 years technical and operational experience in planning/executing/reporting clinical trials • Excellent negotiation and conflict resolution skills • Ability to collaborate across partner functions in a matrix environment • Reproducible results in clinical operations • Ability to work in a global cross-functional team • Strong interpersonal skills • Ability to work under pressure • Resolve issues with supervision and understand when to escalate • Demonstrated ability to effectively manage trial budget Document prepared



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