US-NJ, Associate Global Trial Director 213711BR-MZ
Associate Global Trial Director
Global Drug Development
Global Develop NPH
East Hanover, NJ
Research & Development
Associate Global Trial Director is accountable for planning, executing and to support reporting on one or more global phase II-IV clinical trials, including those in an alliance model, from operational planning through trial close-out, in compliance with Novartis processes, GCP/ICH and regulatory requirements.
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 effective 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
Responsible for ensuring CTT minutes are completed and archived in a timely manner
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 deliverables 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 site initiation
Accountable for assigned trial allocation to ensure optimal patient accessibility, resource 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 review and contribute the monitoring plan (including any tools and forms)
Collaborate with Medical Lead/CS, Analytics, and Data Management (IIS) to ensure relevant data capture tools are created and implemented as documented in data review plan or equivalent document (e.g. CRFs, protocol deviations, questionnaires, diaries, translations, and 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 CRO and alliance partners.
Responsible to report and assess vendor performance ongoing during the trial
4. Manage and coordinate test article and non-drug supplies across regions
Collaborate with drug supply managers to ensure all aspects of the test article are managed throughout the trial. Set up of Interactive Response Technology (IRT) specifications and testing to ensure coordination of test article across regions
Ensure all vendor materials are available and approvals obtained prior to the release of the test article (in collaboration with Drug Supply Management and Local Trial Managers)
5. Manage overall trial conduct to trial close out in coordination with line functions and countries
Manage and oversee resolution of trial operational issues
Develop global recruitment plan including contingencies and implement actions
Collect, track, and communicate trial status for enrollment, timelines, data entry/queries, trial materials; provide updates to relevant boards and countries
Communicate to the countries on timelines, recruitment, trial level issues; manage country site issues; escalate as appropriate
Accountable for accuracy of trial information in all trial databases, trial master file, and tracking systems
Manage trial budget including completion of grant plan specifications, obtain relevant board approvals, revise budget when applicable, and reconcile at trial close out
Ensure timely response to trial audit responses or other quality issues in conjunction with quality assurance
Collaborate with Medical Lead/CS to define the scope of responsibilities of operational and medical/clinical data review within the data review plan or equivalent to ensure ongoing quality data review.
Coordinate with appropriate line functions to ensure data capture and cleaning is consistent with trial timelines; identify issues and drive the process to ensure timely resolution
6. Facilitate trial close out activities
Provide operational support for clinical study report (e.g. appendices)
Ensure complete close out of all sites (vendor materials, budget)
Ensure completion of final drug accountability
Ensure audit readiness including trial master file documentation
7. May serve on or lead work streams or act as Subject Matter Experts for training or SOP.
8. Responsible for implementation of best practices and standards for trial management within the franchise, including sharing lessons learned.
9. GTL can also serve as functional manager for a CM(s) on the CTT for which they lead and participate in the performance review cycle
Key Performance Indicators
Efficient, quality-driven, timely execution of global clinical trials (i.e., best sites selected for a given trial, optimization of study start up, achieve enrolment per plan, and 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 overruns
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
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 understand when to escalate
Demonstrated ability to effectively manage trial budget
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