Central Data Monitoring Expert

Oct 19, 2021

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:

• Responsible for completely overseeing data review activities for assigned trial
• Responsible for developing Monitoring Plans and trial specific tools. Provide input to eCRF design & review, and other documents and systems, as applicable
• Act as a close partner with the CRAs and Trial Team. Is a key team member of the clinical trial team (CTT) and Data Review Team (DRT)
• Perform ongoing central remote monitoring of patient data using available online data sources (eCRF, IRT, central lab etc.) to ensure consistency and correctness of the data
• Communicate any observations, deviations to protocol, safety alerts, quality issues, trends / patterns, risk factors etc. that may affect the planned conduct of the trial to the clinical team and CRAs / directly to site for timely follow-up of actions and issue resolution
• Collaborate with Medical Lead to identify any safety trends
• Prepare and share the Central Monitoring Package with the CRAs prior to monitoring visits
• Interact with DM / programming group and/or other line functions to ensure that efficient tracking and data reports are generated as required with flags and alerts for relevant deviations. Ensure timely data flow and query resolution by DM for effective data review.

Minimum Requirements

• Life Science degree, equivalent, or health care discipline. Clinical Trial monitoring experience that provides the required knowledge, skills and abilities, Fluent English (oral and written).
• 4 years of relevant clinical research experience with knowledge of global drug development process
• Solid understanding of clinical trial design, trial execution and operations. Basic understanding of medical terminology
• Knowledge and experience in international standards (GCP/ICH), international (FDA/EMEA) and local regulations
• Good computer skills (eCRF, EDC, CTMS), experience with remote monitoring and the ability to learn appropriate software
• Good organizational skills, attention to details and ability to prioritize multiple tasks in order to meet project timelines
• Demonstrated ability to establish effective working relationship in a matrix and multicultural environment 8. Strong customer oriented mind-set.

769 million lives were touched by Novartis medicines in 2020, 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!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
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
Hyderabad, AP
Research & Development
Full Time
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Central Data Monitoring Expert

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