360248BR Job ID: 360248BR Job Description: 145 ! Is the number of colleagues in clinical project management contributing to >100 diverse clinical projects across the entire Novartis organization. Come join this team of multi-cultural, motivated and solution-focused colleagues directly impacting the lives of patients and families. Your responsibilities include, but are not limited to: • Execute clinical services and meet planned deliverables in line with defined roles and responsibilities agreed with colleagues/customers. • Support set-up and maintenance of information in Clinical Trial Management Systems (CTMS) and other systems as applicable, under responsibility of COS or CPM as applicable: Update data, timelines, milestones, EC/HA authorizations, etc. on an ongoing basis. • Support (Sr.) Clinical Project Manager (CPM) with study budget management, ensuring accurate planning, tracking and reporting of clinical study budget and Grant Plan as applicable. • Support set-up and maintenance of Trial Master File (TMF): Ensuring that all key documents are present and filed as appropriate in TMF, under responsibility of COS or CPM as applicable. Follow up with Clinical Trial Team at agreed frequency for TMF maintenance. • Track clinical service progress, ensure CTMS, TMF and other systems as applicable are up to date, report to colleague/customer as per scope of work. Address questions; escalate issues or critical findings to project lead (Sr./CPM). • Support in External Service Provider coordination-Support (Sr.) CPM in set up and coordination of External Service Providers, ensuring all information, documentation and material in place for study start during study conduct and close-out. Follow-up with External Service Providers on day-to-day operations. • Ensure all data is reported to the Clinical Trial Team and available to colleague/customer. Logistical support to study team (internal and external) onboarding process • Support in meeting set up, coordination and meeting minutes, running reports from systems, draft project documentation. Support and lead (where applicable) CTT in study start-up activities, recruitment and close-out activities as required. Takes ownership for specific tasks as delegated by project lead. Champion the implementation of operational changes and transitions as required. nnnn Position Title: Senior Clinical Operations Specialist Minimum requirements: • Approximately 5 to 6 years of operational experience of global clinical study execution in a pharmaceutical company or contract research organization. • Experience in finance: forecast, actuals, cost reconciliation, a plus. Strong technical and organizational skills (Excel, MP), Details oriented. • Thorough knowledge of Good Clinical practice. • Demonstrated ability to establish effective working relationship in a matrix and multicultural environment. • Demonstrated presentation and diplomacy skills. Strong customer-oriented mindset. • Able to manage priorities with minimum guidance. Willingness to act accountably in project/study management. Why Novartis? 766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what’s possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis! Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network Job Type: Full Time Country: India Work Location: Hyderabad, AP Functional Area: Research & Development Division: CTS Business Unit: CONEXTS Employment Type: Regular Company/Legal Entity: Nov Hltcr Shared Services Ind Commitment to Diversity & Inclusion:: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Shift Work: No Early Talent: No
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