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Clinical Scientific Expert-I

Clinical Scientific Expert-I

NOVARTIS

5 - 10 years

7 - 12 Lacs

hyderabad

Posted:1 day ago| Platform:

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Skills Required

networking gcp pharma ich

Work Mode

Work from Office

Job Type

Full Time

Job Description

Applies to Clinical Scientific Expert I
The Clinical Scientific Expert I (CSE I) provides clinical and scientific support throughout all phases of a clinical trial under the guidance of the (A)CD(M)D in accordance with Novartis processes, ICH GCP, and regulatory requirements. This role applies clinical data analysis excellence principles and identifies clinical data insights to ensure the scientific plausibility of the data and identify trends, signals, and risks related to trial endpoints and patient safety. The CSE I is a core member of the Clinical Trials Team (CTT) and may support program-level activities as assigned.

About the Role

Major Accountabilities
Implementing plans to solve problems; Assist with program-level activities (e.g., program tracking Manage interactions with relevant line functions, including data management, drug supply management, clinical development, and/or Novartis Country Pharma organizations Report technical complaints/adverse events/special case scenarios related to Novartis products within 24 hours of receipt Distribute marketing samples (if applicable) Key Performance Indicators Facilitates, with appropriate oversight, all relevant aspects of global clinical trial activities to achieve study outcomes within schedule, budget, quality/compliance, and performance standards. May provide lead information on specific aspects of global clinical trials. Core member of the clinical trial team. Applicable to Clinical Scientific Expert I The Clinical Scientific Expert I (CSE I) provides clinical and scientific support throughout all phases of a clinical trial under the direction of the (A)CD(M)D in accordance with Novartis processes, ICH GCP, and regulatory requirements. This role applies the principles of clinical data analysis excellence and identifies clinical data insights to inform scientific data credibility and the identification of trends, signals, and risks related to trial endpoints and patient safety. The CSE I is a core member of the Clinical Trials Team (CTT) and can support program-level activities as assigned. Work Experience Collaboration across organizational boundaries Cross-cultural experience Operational process leadership and execution Project management Clinical trial phases Clinical trial design, data analysis, and reporting Collaboration across organizational boundaries Skills Data integrity Trend analysis Clinical research Clinical trial protocol Life sciences Clinical research Risk monitoring Learning design Language English

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NOVARTIS

Pharmaceutical Manufacturing

Basel Baselstadt

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Clinical Scientific Expert-I