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1 Novartis Clinical Scientific Expert Job
Clinical Scientific Expert II
5-10 years
₹ 8 - 22L/yr (AmbitionBox estimate)
This is an estimate of the average salary range for this
position. It has not been reviewed by the company, and
the actual salary may differ.
Hyderabad / Secunderabad
1 vacancy
Clinical Scientific Expert II
Novartis
posted 9hr ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Summary
-Contributes, with appropriate oversight, to all relevant aspects of global clinical trial(s) activities to deliver study outcomes within schedule, budget, quality/compliance and performance standards. May lead specific aspects of global clinical trial(s). Core member of the Clinical Trial Team, Contributes to operational excellence through process improvement and knowledge sharing and/or provide inputs to clinical development process. -Applicable to Clinical Scientific Expert IIThe Clinical Scientific Expert II (CSE II) provides clinical and scientific support through all phases of a clinical study under the guidance of the (A)CD(M)D in compliance with Novartis processes, ICH GCP and regulatory requirements. This role applies the principles of clinical data review excellence and identifies clinical data insights to ensure data is scientifically plausible and to identify trends, signals and risks associated to trial endpoints and patient safety. The CSE II is a core member of the Clinical Trial Team (CTT). In addition, the CSE II supports/leads program level documents or activities as assigned.
About the Role
Major accountabilities:
- Contributes to all operational/clinical trial deliverables that are in scope of the specific JD, according to timelines, budget, operational procedures, quality /compliance and performance standards.
- Conduct/Contribute to study start-up activities such as overseeing protocol development, CRF development, Informed Consent Form development.
- Ensuring proper handling of all study conduct and close out activities including but not limited to site close out, final drug accountability and audit readiness of Trial Master File documentation (if in scope of the specific JD).
- Responsible for education, implementation and compliance to standards (SOPs) and best practices for clinical operations/clinical data review activities within assigned clinical trial(s) and within clinical program(s), including sharing lessons learned.
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
Key performance indicators:
- Timely, efficient and quality execution of assigned trials and trial related activities within budget, and in compliance with quality standards.
- Proactive operational planning with effective contingency and risk mitigation plans.
- Adherence to Novartis policy and guidelines and external regulations -Applicable for Clincial Scientific Expert II: -Performing clinical data review and insights consistently and accurately which meets the Novartis quality standards, timelines, and is inspection ready.
- High quality contributions to study/ program level and/or submission documents (e.g. IDP, protocol, ICF, clinical sections of CTA).
- Strong leadership skills to be able to support management in team competency building, lead/contribute to local/global initiatives and best practice sharing across programs and/or departments -Clearly demonstrates Novartis Values and Behaviors (i.e. Innovation, Quality, Collaboration, Performance, Courage and Integrity.
Minimum Requirements:
Work Experience:
Work Experience:
- Financial Management.
- Collaborating across boundaries.
- Operations Management and Execution.
- Project Management.
Skills:
- Budget Management.
- Clinical Research.
- Clinical Trial Protocol.
- Clinical Trials.
- Coaching.
- Data Analysis.
- Data Integrity.
- Learning Design.
- Lifesciences.
- Risk Monitoring.
- Trends Analysis.
Languages :
- English.
Employment Type: Full Time, Permanent
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What Clinical Scientific Expert at Novartis are saying
Rating based on 8 Clinical Scientific Expert
reviews
Anonymous · Research & Development
in Hyderabad / Secunderabad
Likes
Learning. Culture, development, bus service etc
- Skill development - Excellent
+2 more
Dislikes
Promotion, appraisal, lay offs, org changes etc
- Promotions - Poor
Clinical Scientific Expert salary at Novartis
reported by
48
employees
with 1-12
years exp.
₹6.5
L/yr - ₹20.5
L/yr
5%
more
than the average Clinical Scientific Expert Salary in India
View more details
What Novartis employees are saying about work life
based on 1.5k employees
Flexible timing
Monday to Friday
No travel
Day Shift
Novartis Benefits
View more benefits
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Novartis Hyderabad / Secunderabad Office Location
Hyderabad Office
Novartis, Salarpuria-Sattva Knowledge City, Madhapur, Madhapur, Inorbit Mall Rd, Silpa Gram Craft Village, HITEC City
Hyderabad
Telangana 500081
Telangana 500081
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