Associate Global Trial Director
Global Drug Development
India Novartis Healthcare Private Limited
Research & Development
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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 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:- details in JD
3. Trial planning, execution and close-out:--- details in job description
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
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 . Minimum requirements Advanced degree or equivalent education/degree in life science/healthcare preferred.
• ≥5 years of related operational and managerial experience in the planning, executing, managing, & reporting of global clinical development trials in a pharmaceutical company or a contract research organization. Overall 10+ years of experience
• 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).
• Good knowledge of therapeutic area preferred