US-NJ, Associate Global Trial Director 216033BR-MZ
Associate Global Trial Director
Global Drug Development
East Hanover, NJ
Research & Development
As the leader of the cross-functional clinical trial team, leads planning and management of the assigned clinical trials end-to-end to achieve Global Program Team (GPT), Global Clinical Team (GCT) and GDO-Trial Management objectives. Complete oversight of budget and resource allocation within assigned trial. Drives operational excellence through process improvement and knowledge sharing across trials within program/franchise. Enables an empowered organization that can navigate in a matrix environment and adjust quickly to business needs. Point of escalation for resolution of trial management operational issues within assigned trial.
1. Lead and manage the global cross-functional CTT to ensure deliverables are met within the established timelines, budget and quality/compliance standards; accountable for representation at all internal meetings related to the clinical trial: chair the routine CTT meetings, participate and report study progress and issues/resolution plan at the International Clinical team/Global Clinical Team (ICT/GCT). Core member of the ICT/GCT.
2. Leads the development of global clinical trial protocol(s) by translating the approved trial concept sheet(s) into efficient, high quality, executable clinical protocols:
Responsible for integrating and authoring clinical trial protocol(s) and related documents (e.g. informed consent) in collaboration with the Clinical Development Representative, the CTT and the Novartis Country Pharma Organizations (CPOs);
Submit clinical trial protocol(s) to internal review board for approval;
Lead the development of scientific trial related documents (e.g. charters, scientific training material) with input of the Clinical Development Representative;
Organize and participate in trial advisory committees (e.g. Data Monitoring Committee, Steering Committee).
3. Trial planning, execution and close-out:
Oversee trial feasibility and site selection process in collaboration with Trial Monitoring organization;
Ensure all required documentation is provided to each participating country for Health Authority (HA) and/or Institutional Review Board (IRB)/Institutional Ethics Committee (IEC) submissions;
Conduct investigator meetings/trainings in collaboration with the Novartis CPOs;
Responsible for ensuring trial information/results are reported within relevant trial repositories and tracking systems (e.g. trial results registries)
Forecast and manage drug supply for Novartis and comparator drug products in collaboration with internal stakeholders;
Develop clinical outsourcing specifications (as required) to facilitate bid process and selection of Contract Research Organizations (CROs); manage interface with CROs in cooperation with outsourcing management and line functions; ensure vendors meet quality standards; contribute to the development/amendment of vendor contracts;
Contribute to the development of Case Report Forms (CRFs), edit checks, CRF completion guidelines, data review reports and trial statistical analysis plan in collaboration with the trial data manager, trial statistician, statistical programmer and Clinical Development Representative.
Create and drive trial level timelines;
Create and execute an operational risk management plan highlighting potential risks and actions;
Develop global recruitment plan including contingencies in collaboration with Trial Monitoring;
Manage and oversee resolution of trial operational issues;
Provide updates on trial progress to relevant boards;
Provide oversight on quality and compliance for assigned clinical trial(s) in conjunction with Process Control Managers (PCMs);
Ensure proper handling of all study close out activities including but not limited to site close out, final drug accountability and audit readiness of Trial Master File documentation;
Manage and contribute to the development of Clinical Study Reports; Reporting of clinical trial results and internal/external publications
4. Resource Management:
Assess trial resource needs in collaboration with Global Trial Program Head (GTPH)
Accountable for trial level life cycle budget management including forecast and annual cost targets; owner of and accountable for clinical work package; accountable to ensure trial budget is revised when applicable.
5. Lead the CTT in defining the data review plan and ensure ongoing data review and cleaning activities are meeting the quality standards in support of database locks in collaboration with Clinical Development and Data Management; participate in data review as specified in the Data Review plan.
6. Build best talent and an empowered culture within program(s) and franchise to foster high performance in a matrix environment. Assess needs of the organization to improve the medical/scientific, operational and budget management capabilities in assigned franchise, in alignment with the Franchise Head TM and other GTPHs.
Responsible for overall management of trial management associates working on assigned clinical trial(s) including performance management and career development
Assign study responsibilities to assist in the planning, conduct and reporting of clinical trials
7. Drive functional excellence in education, implementation and compliance to best practices for trial management, franchise and GDO TM, including sharing lessons learned.
8. Reviewer of relevant SOPs.
9. Key contributor and/or co-chair for Franchise/GDO Trial Management forums, initiatives or working groups. May serve as faculty member for franchise training programs and role model .
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.
Advanced degree or equivalent education/degree in life science/healthcare preferred.
Languages: Fluent English (oral and written)
5 years of operational and managerial experience in planning, executing, reporting global clinical trials in a pharmaceutical company or a contract research organization.
Proficient communication, influencing and negotiating skills. Strong project management skills and demonstrated ability to meet timelines.
Proven ability to work independently in a complex matrix environment (including remote or virtual team environment).
Experience in developing effective working relationships with internal and external stakeholders
Organizational awareness, including experience working cross-functionally and in global teams.
Strong interpersonal, problem-solving, negotiation and conflict resolution skills.
Established knowledge of Good Clinical Practice, clinical trial design and global drug development process.
Proven record of managing resources
(budget and headcount).
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