Carrier as Clinical Scientific Expert-I @ Novartis
The Clinical Scientific Expert I is responsible for ensuring the collection, review/reporting of high quality trial data, and study reporting/publishing in compliance with Novartis processes, GCP/ICH and regulatory requirements. In addition, responsible for ensuring high quality scientific inputs (under supervision) to the clinical development process and support program level activities as assigned.
• In collaboration with Trial Statistician, support development of Reporting and Analysis Planning (RAP) modules in line with program standards.
• Responsible to support development of and implementation of relevant data capture tools in collaboration with CSD, GTL and IIS as documented in data handling plan or equivalent document (e.g. CRFs, protocol deviations, questionnaires, diaries, translations, edit checks)
• Responsible for performing the ongoing review of clinical trial data as outlined in the data handling plan or equivalent, supports GTL to prepare database lock; and performing data reconciliation along the whole trial duration in collaboration with management.
• Collaborate with Medical Lead/BSL to identify any safety trends; and as needed, reports on trial data to safety and clinical boards (e.g. SMT, GCT, and GPT).
• In collaboration with Medical Lead or CSD/CSAD, responsible for final analysis and interpretation of results including the development and drafting of clinical trial reports, publications, and internal/external presentations. Provide support for biomarkers planning and or execution
• May support global process improvement work as assigned. May support CSD in limited program level activities where needed including submissions.
• Demonstrates scientific writing skills to enable the development of quality clinical protocols, trial reporting, and regulatory documents including high quality clinical /Scientific of clinical communication and publications
• Submission of quality clinical documents at Final Protocol Package (e.g. protocol, ICF, clinical sections of CTA)
• Data cleaning & review process is successfully accomplished within the required timelines across the trial with 100% clean data and no unplanned database unlocks• High quality, timely clinical data review and document preparation Meeting NVS quality standards, reviews and audit.
Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. PharmD, PhD is preferable. Fluent English (oral and written)
•>1 year experience in Pharmaceutical industry/ clinical research organization
•Basic knowledge in planning, executing, reporting and publishing global clinical studies in a pharmaceutical company or contract research organization.
•Work experience in clinical operations preferable.
•Strong interpersonal skills
•Ability to work under pressure
•Good negotiation and conflict resolution skills
•Collaborates across boundaries for shared success
•Resolve issues with minimal supervision and understands when to escalate
•Fundamental knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development process
•Strong analytical / computational background
•Demonstrates strong Medical / scientific writing skills
•Demonstrates knowledge and application of statistical analysis methodology and can identify trends and analyze / interpret / report data effectively.
Experience : > 1 year
Qualification : degree in life sciences
Location : Hyderabad
Industry Type : Pharma / Biotech / Clinical Research
Functional Area : R&D
Last date : 20th November, 2016
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