Global Clinical Operations-Senior Study Leader

Accountable, with per needed-basis oversight from the Study Director-community Lead (SD-CL), for the execution and delivery of the GCO supported clinical studies of standard to medium complexity and priority per the Operational Execution Plan (OEP) and clinical study protocol.The Senior Study Leader co-leads together with the Clinical Science Lead (CSL) 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. Accountable for proactive, iterative operational planning with effective contingencies and embedded risk management mindset in CTT. Oversee budget and people allocation within assigned study/studies.Contribute in promoting 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.

Key Responsibilities： Co-Leader of the Clinical Trial TeamCo-leads the clinical trial team with the CSL with per needed-basis oversight from the Study Director-Team Lead (SD-TL) and support from the Clinical Operations Program Head (COPH), delivery of multiple medium to complex global studies and promotes learning, sharing, consistent performance, and operational excellence through an agile mindset, agile principles, and a team of teams’ modelActs as the CTT product owner with duties and responsibilities for delivery of operational strategy per established 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 protocolFosters an agile culture within assigned studies to achieve sprint goals and cycles, maximizing collaboration and minimizing dependencies to achieve long-term business impactIn collaboration with regulatory writing and clinical development, promotes operational excellence in the development of global clinical study protocol(s), by translating the approved study concept sheet(s) into efficient, high quality, executable clinical protocols, and study-related documentsCreate effective CTT dynamics and achieve on performance, prioritization, and communication in close collaboration with CTT sub-team leadersProactive risk management and inspection readinessResponsible for developing clinical study timelines with per needed-basis oversight from the Study Director-community Lead (SD-CL) and support from the Clinical Operations Program Head (COPH), and overseeing assigned study budgetsDocument prepared by: M. RuffinDate of issue: 21 Feb 2025Ensures systems are maintained with up-to-date study status, risks, and issuesFosters a close working relationship with SSO Clinical Project Managers (CPMs) to strengthen the relationship between the global and local teamsOversees study recruitment and responsible for activating mitigation strategies in collaboration with the SSO Clinical Project Managers (CPMs)Fosters a close working relationship with the Vendor Partnerships & Governance (VPG) Trial Vendor Managers (TVMs) to strengthen the relationship between the vendors and CTT to deliver on clinical study objectivesFosters a close working relationship with the Clinical Data Operations (CDO) Trial Data Scientist (TDS) to deliver on clinical study objectivesEnsures 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 documentationPromotes operational excellence and contributes to the development of Clinical Study Reports, reporting of clinical trial results, and internal/external publications, when appropriateMay deputize for the Clinical Operations Program Head as a leader and spokesperson for the CTT at Novartis internal meetingsPartners and collaborates with Portfolio Strategy & Planning (PSP)/COPH to deliver clinical studies in alignment with program strategyPlay a key role in achieving 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 managementPartners and collaborates with functional line leadership to ensure optimal people staffing of the study teamBuild high-performing teams and create an empowered, psychologically safe culture to foster high performance in a matrix environmentServes as the single point of contact as the SSO representative in the CTT for internal/external customersTeam/Community participationActive member of a community(ies) as a citizen within the study leadership organizationApply and encourage new CTT mindset, values, and principles; be a catalyst for these CTT ways of working (incl agile).Essential Requirements:  Bachelor’s degree in life sciences/healthcare (or clinically relevant degree) is required. Advanced degree is strongly preferred.Fluent English, oral and written≥ 4 years of recent involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV of standard to high complexity and priority≥ 3 years of recent contribution to and accomplishment in all aspects of conducting clinical studies of standard to high complexity and priority (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 standardsExperience in managing people globally in a complex matrix environment preferredManagement of virtual teams. Proven ability and strong experience leading teams and building capabilitiesExperience in developing effective working relationships with internal and external stakeholdersExcellent communicator and presenter (oral and written); ability to communicate at all levelsDesirable Requirements: Excellent organization and prioritizationStrong negotiation and conflict resolution skills and enterprise mindsetStrong project management skills and demonstrated ability to meet timelinesProven track record in trial operations process improvement(s) in some aspects of clinical trialsSuperior strategic thinking with strong analytical and problem-solving skillsKnowledge of appropriate therapeutic area strongly preferred