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Amerisource Bergen
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Assistant Manager, Clinical Services

Assistant Manager, Clinical Services

Amerisource Bergen

7 - 12 years

7 - 11 Lacs

Noida Thane

Posted:1 month ago| Platform:

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Skills Required

Training Legal Life sciences Pharmacology Management Statistics ICH Data interpretation Recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

To author, review, and independently manage high-quality clinical documents: Clinical Study Reports (CSR) including narratives, Protocol, and Informed Consent Form (ICF). Review and Preparation of regulatory documents as per country-specific regulatory requirements. Clinical Trial Documents (CTD) Modules (2.4, 2.5) Contribute to the planning of data analyses and presentations to be used in CSRs; Ensure compliance with documentation Excellent data interpretation skills. Understanding of ICH-E6 and E3 guideline. Understanding of template for Protocol as per ICH-E6 and Transcelerate Common trial protocol Basic understanding of statistics Relevant Experience and Education Postgraduate in Pharmacy (Pharmacology), Life Sciences, PharmD 7-12 years of experience in core medical/regulatory writing Excellent communication skills Ability to manage multiple projects and meet tight deadlines.

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Amerisource Bergen

Pharmaceutical Distribution

Chesterbrook

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Assistant Manager, Clinical Services