Clinical Operations Specialist

Job title: Clinical Operations Specialist

Company: The Medicines Company



Job description: 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

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. Our CPM organization offers a dynamic and flexible environment to enable you to learn and grow your cross-functional expertise Your responsibilities include, but are not limited to: Trial budget management Responsible for evaluation of investigators fees (country level budget/ Grant Plan) estimates per country and the negotiation of investigators fees and country related trial costs. Support Trial Manager ensuring accurate planning, tracking and reporting of trial(s) budget. Vendors coordination Once agreement in place, support trial Manager in the set-up and coordination of third-party vendors (i.e. central lab, investigators meeting organization) ensuring all information, documentation and material in place for trial start. Responsible for effective and smooth workflow between trial participants (i.e. third-party vendors and country/sites management).Follow-up with vendors on day to day operations (recruitment reports, delivery of study kits ) Monitor status of final invoices Trial logistics Responsible for the set-up and maintenance of trial(s) in Clinical Trial Management Systems: For trial timelines and key milestones, enrolments, sites information as appropriate (i.e. ClinAdmin), generate enrolment curves to support reporting Project files up to date in CREDI (all study related documents on top of protocol and amendments). Checking countries and HQ TMF, ensuring all key documents are present and filed as appropriate. Final Protocol Packages availability. Ensure availability of trial material for country management /sites (i.e. IV bags, fridge, laptops, etc ) including tracking of rented material. Support Trial Manager in keeping overview of drug availability at site level in collaboration with country management and drug supply management. Support Trial Mgrs. in meeting set-up, minutes, running reports from systems, draft trial documentation [#video#https://www.youtube-nocookie.com/embed/E1T5uTRV5_U{#400,300#}#/video#] Minimum requirements At least 6 years operational experience of clinical study execution in a pharmaceutical company or contract research organization. Life Science degree or equivalent Exposure to finance processes & reporting a plus. Fluent English (oral and written). 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 8. Willingness to act accountably in project / trial management Why consider Novartis? 799 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives? We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges. We are Novartis. Join us and help us reimagine medicine. Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.

Expected salary:

Location: Hyderabad, Telangana – Secunderabad, Telangana

Job date: Thu, 15 Apr 2021 22:38:04 GMT

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