SUMMARY

The Study & Site Operations (SSO) Portfolio Team Lead is responsible for the Clinical Project Managers (CPMs) and SSO Feasibility Managers and their study specific activities, including the hiring, training, development, and assignment to ensure adequate and timely portfolio execution. The SSO Portfolio Team Lead assures that CPMs coordinate their activities across all CRAs working on the same trials/projects in collaboration with the Clinical Research Associate (CRA) Managers/FSP line managers.
The SSO Portfolio Team Lead is responsible for CPMs and SSO Feasibility Managers’ compliance of study management activities and for the delivery of study achievements, in close collaboration with the CRA Managers/ FSP line managers and aligned with Global and local medical strategy, in the country structure. The Portfolio Team Lead is responsible for overall portfolio execution related performance (KPIs), ensuring the study milestone deliverables, in accordance with GCP, ICH, SOP’s, and local regulations.
This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager.

LI-Remote

KEY RESPONSIBILITIES:

Portfolio Execution strategy

• Collaborate with Country Head, Country Portfolio Head and CRA Managers/FSP line managers to implement country innovative practices and patient engagement tactics (as appropriate) to advance clinical trial planning, execution and quality in line with Portfolio Execution country leadership
• Identifies and leads innovative solutions to further advance Project Management in GDD portfolio, in collaboration with Study & Site Operations country leadership
• Supports the Country Portfolio Head in implementation of the global strategy within the country structure (incl. escalation & risk mitigation, as well as study allocation to CPMs)

Allocation, initiation and conduct of trials

• Develop opportunities in collaboration with SSO Feasibility Manager, Country Portfolio Head and relevant medical/clinical functions to build a competitive advantage for GDD trials within the country, ensuring alignment with the local medical standard of care, local business drivers and site relationship management
• Ensures that SSO Feasibility Managers provide comprehensive proposals and timelines for country allocation, including early identification of risk and opportunities for the clinical program/trial
• Operationally supports allocation of new trials in collaboration with Study & Site Operations Country leadership, during trial feasibility/allocation

Delivery of quality data and compliance to quality standards

• Collaborate with Clinical Research Associate (CRA) Manager to ensure that monitoring trends that require targeted training and/or development are escalated.
• Coordinates between the Clinical Research Associate (CRA) Manager, CPM and SSO Site Partnership Manager to ensure that site issues, data flow and commitment deviations are addressed and escalated.
• Ensures adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements

Management of people and resources management

• Is responsible for the hiring, training, development, and retention of a team of Clinical Project Managers (CPMs) and SSO Feasibility Managers to ensure study milestones are delivered for the Innovative Medicines Phase I-IV Global Drug Development (GDD) trials
• Together with the country Portfolio Head performs ongoing assessment and allocation of CPMs, and SSO Feasibility Manager resources within Country and Hub to ensure balanced workload

ROLE REQUIREMENTS:

• A degree in scientific or health discipline required
• Advanced degree, preferred
• Minimum 8 years’ experience in clinical research and/or project management
• People management experience with evidence of team management and leadership capabilities
• Understanding of all aspects of clinical drug development with particular emphasis on monitoring and trial execution
• Excellent project management capabilities with demonstrated capability to problem solving and mediate complex compliance issues
• Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations and Novartis standards
• Demonstrated negotiation and conflict resolution skills both internal and external (site relationships)
  The salary for this position is expected to range between: $185,500- $344,500/year.
  The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
  Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
  US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
  To learn more about the culture, rewards and benefits we offer our people click here.
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