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Apply to JobJob ID250524BRPosition TitleGMA Associate Global Trial DirectorJob DescriptionAs the leader of the cross-functional clinical trial team, The GMA Associate Global Trial Director (aGTD) leads the 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. They have oversight of budget and resource allocation within the assigned trial and drive operational excellence through process improvement and knowledge sharing across trials within the disease area. The aGTD enables an empowered organization that can navigate in a matrix environment and adjust quickly to business needs and is the point of escalation for resolution of trial management operational issues within assigned trial(s).



Main Accountabilities:

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.

3. Trial planning, execution and close-out.

4. Assess 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 e.g. Investigators’ Brochures, annual safety update reports.

16. Participate in GMA and cross-functional initiatives. Contribute to achievement of initiative objectives.Minimum requirementsEducation:

Advanced degree or equivalent education/degree in life science/healthcare preferred.



Languages:

Fluent English (oral and written)



Skills & Experience

• ≥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.DivisionOncologyBusiness UnitONCOLOGYLocationSwitzerlandSiteBaselCompany/Legal EntityNovartis Pharma AGFunctional AreaResearch & DevelopmentJob TypeFull TimeEmployment TypeRegular

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