Assistant Manager, Clinical Services
Assistant Manager, Clinical Services
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Job Description
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 timeAffiliated Companies
Affiliated Companies: PharmaLex India Private LimitedEqual 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 companys 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 888.692.2272 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
Required Experience:
Manager
Employment Type
Full-Time
