Assistant Manager, Clinical Services

2 days ago

Noida, Uttar Pradesh, India AmerisourceBergen Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today

Job Details

Job Description

  • To author, review, and independently manage high-quality clinical documents: Clinical Study Reports (CSR) including narratives, Protocol, and Informed Consent Form (ICF), Investigator Brochure.

  • Review and Preparation of regulatory documents as per country-specific regulatory requirements. Clinical Trial Documents (CTD) Modules (2.4, 2.5, 2.6, 2.7)

  • Excellent skillset in literature search, understanding of PICOS criteria and PRISMA statement

  • 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 other ICH and regulatory guideline required for drug development.

  • 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.

What Cencora offers

​Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

Full time Affiliated Companies
Affiliated Companies: PharmaLex India Private Limited Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call or email **** We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

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