Job Description

Agree with colleague/customer team and Line Functions on realistic project and study timelines. Escalate to higher level in the organization if no agreement can be achieved or support the Sr. CPM (where applicable). Lead and manage a multidisciplinary cross functional Clinical Trial Team (CTT) (medical writing, statistics, data management, monitoring partner, drug supply, regulatory, safety etc.) or support the Sr. CPM (where applicable) in the effective planning, regular re-evaluation and implementation of assigned clinical studies and/or MAP//Research Collaborations/IIT/Digital Solutions programs according to Novartis Global processes ensuring adherence to timelines, budget, quality standards and operational procedures. Might be required to support or lead other projects/program, in collaboration with cross-functional teams.` Responsible for investigators meeting organization and all internal meetings related to the clinical study execution and operational excellence. As applicable, directly interact with investigator sites and CRAs/CROs/vendors to ensure smooth study set up and smooth study conduct, reviewing site performance, protocol deviations, ongoing risk assessment and timely issue resolution in alignment with Novartis global standard with local regulation requirement. As applicable, support compilation of study regulatory documents for submissions to competent authorities and ethics-committees in collaboration with other associated CONEXTS, Novartis line functions and CRO Partners as required. Also, if needed support clinical studies with all onsite/remote monitoring activities and communications with investigators, investigational sites, clinical trial team, healthcare professional and other associated internal line-functions. As applicable, responsible for review of all site visit related reports and quality control of monitoring activities in timely manner. Role Requirements Approximately 8 years of Global Clinical Operations experience with managerial experience in designing, planning, executing, reporting and publishing clinical studies (interventional and non-interventional clinical studies, early to late phase) in a pharmaceutical company or contract research organization. Proven ability to work independently in a complex matrix environment (including remote), including leading cross-functional team. Desirable Requirements: Solid project management skills. Thorough knowledge of Good Clinical Practice, clinical study design, statistics, regulatory processes, and global clinical development process. Demonstrated presentation and diplomacy skills. Negotiation and conflict resolution skills. Strong customer-oriented mindset. Ability to resolve issues with minimal supervision and understand when to escalate. Willingness to act accountably in project/study management

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