Job Description

Summary The Senior Study Leader is responsible for the execution and delivery of the Global Clinical Operations (GCO), clinical studies in accordance with the Operational Execution Plan (OEP) and clinical study protocol.
You will lead the cross-functional Clinical Trial Team (CTT) and guide the planning and management of assigned clinical study/studies end-to-end to achieve Global Program Team (GPT), Global Clinical Team (GCT) and GCO objectives.YOUR KEY RESPONSIBILITIES:Your responsibilities include, but are not limited to:

• Lead the CTT delivery of multiple medium to complex global studies and promote learning, sharing, consistent performance, and operational excellence through an agile mindset, agile principles, and an agile team of teams model
• Act as the CTT product owner with duties and responsibilities per the agile ways of working
• In collaboration with regulatory writing and clinical development, promote 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 documents
• Create effective CTT dynamics and achieve on performance, prioritization and communication in close collaboration with CTT sub-team leaders
• Responsible for developing clinical study timelines and overseeing assigned study budgets
• Oversees study recruitment and responsible for activating mitigation strategies in collaboration with the Study & Site Operations (SSO) Clinical Project Manager Country representatives
• Ensures proper handling of all study close out activities including but not limited to site close out, final drug accountability and audit/inspection 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 .

WHAT YOUxe2x80x99LL BRING TO THE ROLE:

• Advanced or Bachelorxe2x80x99s degree in life sciences/healthcare or clinically relevant degree (or equivalent). 12- 15 years of Industrial experience in Clinical Research or Drug Development in any Phase.
• Significant recent experience in various aspects of clinical trial activity in a global/matrix environment in pharmaceutical industry or a Contract Research

Organization Including expert knowledge of international standards (ICH-GCP), health authorities (FDA/EMA)

• Experience of leading and/or working with a global team in a matrix environment, including the management of virtual teams and strong experience leading teams and building capabilities
• Experience in developing effective working relationships with internal and external stakeholders
• Strong negotiation and conflict resolution skills and enterprise mindset, demonstrated by ability to drive for aligned solutions for SSO and GCO
• Strong project management skills and demonstrated ability to meet timelines
• Proven track record in trial operations process improvement(s)

Skills Desired Auditing, Clinical Monitoring, Clinical Research, Clinical Trials, Data Management, Global Project Management, Health Sciences, Lifesciences

Novartis