Job ID 229182BR
Position
Title Clinical Scientific Expert - II
Division Global Drug Development
Business
Unit CD&A GDD
Country India
Work
Location Hyderabad
Company/Legal
Entity Novartis Healthcare Shared Services India
Functional
Area Research & Development
Job Type Full Time
Employment
Type Regular
Job Description
Clinical Scientific Expert II 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 to the clinical development process and support program level
activities as assigned.
Minimum requirements
ü In collaboration with Trial Statistician, support
development of Reporting and Analysis Planning (RAP) modules in line with
program standards.
ü Responsible to provide expert support in 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)
ü Responsible for performing expert review of on-going
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.
ü 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).
ü 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.
ü Provide support for biomarkers planning and or execution
ü Lead/ participate in global process improvement work
streams or act as Subject Matter Experts for training or SOP.
ü May support CSD in program level activities where needed
including submissions.
ü Participate in the on-boarding, mentoring and training of
CSE1 and new hires
ü Demonstrates strong scientific writing skills to enable
the development of quality clinical protocols, expert in trial reporting, and
regulatory documents including high quality clinical /scientific clinical communication
and publications
ü Submission of quality clinical documents at Final
Protocol Package (e.g. protocol, ICF, clinical sections of CTA)
ü Data cleaning & review process is successfully
accomplished within the required timelines across the trial with 100% clean
data and no unplanned database unlocks
ü High quality, timely clinical data review and document
preparation meeting NVS quality standards, reviews and audit.
Minimum Qualifications:
ü Advanced (masters) degree in life sciences/healthcare (or
clinically relevant degree)/ Pharm
D is required. PhD or MD preferable. Fluent English (oral and written)
ü >3 years experience in Pharmaceutical industry/ clinical
research organization
ü Advanced knowledge with hands on experience in planning,
executing, reporting and publishing global clinical studies in a pharmaceutical
company or contract research organization.
ü Strong interpersonal skills
ü Ability to work under pressure
ü Excellent negotiation and conflict resolution skills
ü Collaborates across boundaries for shared success
ü Resolve issues with minimal/ no supervision and
understands when to escalate
ü Thorough knowledge and expertise in Good Clinical
Practice, clinical trial design, statistics, regulatory processes, and clinical
development process
ü Strong analytical / computational background
ü Demonstrates excellent Medical / scientific writing
skills
ü Demonstrates expert knowledge and application of
statistical analysis methodology and can identify trends and analyze/
interpret/ report data effectively.
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