Band

Level 4

Job Description Summary

Responsible for the execution and delivery of GCO supported clinical studies per the Operational Execution Plan (OEP) and clinical study protocol. The Study Leader is the leader of the cross-functional clinical trial team (CTT), guides planning and management of the assigned clinical study/studies end-to-end to achieve Global Program Team (GPT), Global Clinical Team (GCT) and GCO objectives. Oversee budget and people allocation within assigned study/studies. Promotes operational excellence through process improvement and knowledge sharing across studies. Fosters an empowered, psychologically safe organization that can navigate a matrix environment, learns, and adjusts quickly to changing conditions and business needs. Accountable for resolution of study management operational issues and impediments within assigned study/studies.

Job Description

Key responsibilities:

• Leader of the Clinical Trial Team

  • Leads the clinical trial team delivery of multiple global studies and promotes learning, sharing, consistent performance, and operational excellence through an agile mindset, agile principles, and an agile team of teams model

  • Acts as the CTT product owner with duties and responsibilities per the agile ways of working

  • Guides planning and decision making at the study level and delivers assigned clinical study/studies per the Operational Execution Plan (OEP) and clinical study protocol

  • Fosters an agile culture within assigned studies to achieve sprint goals and cycles, maximizing collaboration and minimizing dependencies in order to achieve long-term business impact

  • In collaboration with regulatory writing and clinical development, promotes operational excellence in the development of global clinical trial protocol(s), by translating the approved study concept sheet(s) into efficient, high quality, executable clinical protocols, and study-related documents

  • Create effective CTT dynamics and achieve on performance, prioritization, and communication in close collaboration with CTT sub-team leaders

  • Proactive risk management and inspection readiness

  • Responsible for developing clinical study timelines and overseeing assigned study budgets

  • Ensures systems are maintained with up-to-date study status, risks, and issues

  • Fosters a close working relationship with SSO Clinical Program Managers (CPMs) to strengthen the relationship between the global and local teams

  • Oversees study recruitment and responsible for activating mitigation strategies in collaboration with the SSO Clinical Program Managers (CPMs)

  • Fosters a close working relationship with the VPG Vendor Program Managers (VPMs) to strengthen the relationship between the vendors and CTT to deliver on clinical study objectives

  • Fosters a close working relationship with the CDO Trial Data Scientist (TDS) to deliver on clinical study objectives

  • Ensures 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

  • Promotes operational excellence and contributes to the development of Clinical Study Reports, reporting of clinical trial results, and internal/external publications, when appropriate

  • Partners and collaborates with PSP/Clinical Operations Program Head (COPH) to deliver clinical studies in alignment with program strategy

  • Achieves excellence in study operations and management through process improvement in collaboration with the Study Leadership Community Lead/Host and GCO Process, Training, and Compliance (PTC)

• CTT coaching and resource management

  • Partners and collaborates with functional line leadership to ensure optimal people staffing of the study team

  • Build high-performing teams and creates an empowered, psychologically safe culture to foster high performance in a matrix environment

  • Serves as the single point of contact as the SSO representative in the CTT for internal/external customers

• Community participation

  • Active member of a community(ies) as a citizen within the study leadership organization

  • Apply and encourage agile mindset, values, and principles; be an ambassador for agile and a catalyst for these new ways of working

Essential requirements:

• ≥ 2 years of recent involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV

• ≥ 1 year of recent contribution to and accomplishment in all aspects of conducting clinical studies (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry or a contract research organization, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations and Novartis standards

• Experience in managing people globally in a complex matrix environment preferred

• Management of virtual teams. Proven ability and experience leading

• Experience in developing effective working relationships with internal and external stakeholders

• Fluent English, oral and written

Desirable requirements:

• Strong communicator and presenter (oral and written)

• Strong organization and prioritization

• Strong negotiation and conflict resolution skills and enterprise mindset, demonstrated by ability to drive for aligned solutions for SSO and GCO/GDD

• Strong project management skills and demonstrated ability to meet timelines

• Strong strategic thinking with analytical and problem-solving skills

• Knowledge of appropriate therapeutic area preferred

Skills Desired

Auditing, Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trial Management Systems, Clinical Trials, Data Auditing, Data Management, Health Sciences, Lifesciences, Project Planning, Vendor Management, Waterfall Model