As the leader of the cross-functional clinical trial team, leads planning and management of the assigned clinical trials end-to-end to achieve Oncology Medical Affairs (OMA), Global Medical Affairs (GMA), GMA Franchise, Global Clinical Team (GCT) and Clinical Trial Team (CTT) objectives. Oversight of budget and resource allocation within assigned trial. Drives operational excellence through process improvement and knowledge sharing across trials within disease area. 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(s).
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 clinical trials; chair the routine CTT meetings, report study progress and issues/resolution plan at the Global Clinical Team (GCT). Core member of the GCT.
2.Lead 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 Global Medical Director, the CTT members 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 of the Global Medical Director, and other line functions (e.g. data management, statistical analysis, etc.) as needed
Organize and participate in trial advisory committees (e.g. Data Monitoring Committee, Steering Committee).
Collaborate with the Global Medical Directors and Advisors of the major Novartis local medical organizations to ensure country feedback is adequately integrated into protocol.
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. Provide study specific training for Novartis CPOs and Regions
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
Create and drive trial level timelines
Create and execute an operational risk management plan highlighting potential risks and actions
Support implementation of 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 Medical Business Operations and Functional Excellence.
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
4Assess trial resource needs in collaboration with GMA Disease Area Trial Director.
5.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.
6.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 Data Management; participate in data review as specified in the Data Review plan.
7.Build best talent and an empowered culture within disease area to foster high performance in a matrix environment.
8.Responsible for overall management of trial management associates working on assigned clinical trial(s) including performance management and career development as applicable
9.Drive functional excellence in education, implementation and compliance to best practices for trial management, including sharing lessons learned.
10.Manage the on-boarding, and training of new Clinical Operations staff as applicable. May serve as faculty member for training programs.
11.Reviewer of relevant SOPs/Working Practices.
12.Oversee third-party Investigator Initiated Trials (ITTs), oversee Regional and Locally Sponsored Novartis Trials within disease area. Provide feedback on study proposals, review submitted study concepts/protocols for core requirements via the corresponding systems. Collaborate with local CPOs and Regions to track study progress, update databases and oversee budget.
13.Ensure compliance with Novartis SOPs, Business Guidance and regulatory requirements.
14.Manage Managed Access Program as assigned. Manage physician request, provide treatment plan guidance, ensure compliance with SAE reporting, and manage drug supply. Awareness of local regulatory requirements.
15.Contribute to the development of clinical sections of regulatory documents like e.g., Investigators Brochures, annual safety update reports.
16.Participate in GMA and cross-functional initiatives. Contribute to achievement of initiative objectives.
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.
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.
Working knowledge hematology/oncology/endocrinology knowledge of therapeutic area is preferred.
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).
Good knowledge of therapeutic area preferred
* If a direct employer requests that you go to their web site and complete your application there in order to be
considered, please do so. Applications for all positions are subject to each employer's specific requirements.