Job details
Job type full-time
Full job description
“150! clinical scientific experts, globally, are part of global drug development (gdd) team, working to ensure clinical trial data and regulatory reports are of highest quality throughout the life cycle of each program, across all disease areasBe part of a dedicated, passionate team that is diligently providing clinical and scientific inputs at study and program level, thereby supporting novartis in reimagining medicine for patients worldwide.”
Your responsibilities include, but are not limited to:
Responsibility for ensuring high quality clinical trial data review/insights and analysis as advised by the integrated clinical trial team (ictt)
Perform high quality clinical data review and identify clinical data insights through patient level review and trends analysis, supporting interim analysis, database and post lock activities and facilitate resolution of clinical data issues.
Collaborate with relevant line functions to improve the quality of clinical data review/insights with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review.
Chips in to the development the data review/quality plan (drp/dqp) and data review strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments & other aspects of the protocol are implemented consistently across the study.
In conjunction with the relevant line functions, may supply to case report form (crf) development, and support the implementation of data capture tools.
Chip in to and facilitate data review process improvements e.gIdentification of delinquent/redundant reports and/or implementation of innovative data analysis processes and tools.
May supply (in collaboration with relevant line functions) to the development of study-level documents, including clinical sections of key regulatory documents, such as investigator’s brochures, briefing books, safety updates and submission dossiersIn collaboration with relevant line functions, review/write clinical trial documents for study csr activities, and publications.
May support pharmacovigilance activities (e.g., reviewing/chipping in to aggregate reports/patient narratives, attendance of safety monitoring meetings (smt)), if requiredProduce training materials and provide training to ictt.
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.
Minimum requirements
Sophisticated degree in life sciences/healthcare (or clinically relevant degree) is requiredPhd, mbbs, bds, md strongly preferableProficient english (oral and written).
>1 year experience in pharmaceutical industry/ clinical research organizationBasic knowledge in planning, executing, reporting and publishing global clinical studies in a pharmaceutical company or contract research organization.
Work experience in clinical operations preferableStrong social skills - ability to work under pressureGood negotiation and conflict resolution skillsCollaborates across boundaries for shared success
Resolve issues with minimal direction and understands when to raiseFundamental knowledge of good clinical practice, clinical trial design, statistics, regulatory processes, and clinical development process
Strong analytical / computational backgroundDemonstrates strong medical / scientific writing skillsDemonstrates knowledge and application of statistical analysis methodology and can identify trends and analyze / interpret / report data optimally.
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 innovationThat 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 flexibilityAnd we can reinvent what`s possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challengesBecause 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 teams 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
Division
Global drug development
Business unit
Gdo gdd
Country
India
Work location
Hyderabad, ap
Company/legal entity
Nov hltcr shared services ind
Functional area
Research & development
Job type
Full time
Employment type
Regular
Shift work
No
Early talent
No
Hiring insights
Job activity
Posted 19 days ago
