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Novartis is a global healthcare leader and has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented, performance driven people. All of which makes us one of the most rewarding employers in our field. We appreciate and welcome your interest in joining our team of associates from more than 150 nationalities who currently share our mission to care and to cure.
Job ID : 201769BR
Position : Title Clinical Scientifc Expert – I
Division : PHARMA
Business Unit : Global Develop NPH
Country : India
Work Location : Hyderabad
Functional Area : Research & Development
Job Description
- 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.
Minimum requirements
- 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.
