Senior Manager, Clinical Services

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 7-12 years of experience in core medical/regulatory writing Ability to manage multiple projects and meet tight deadlines. Attention to detail and strong analytical skills. Excellent written and verbal communication skills Role: Healthcare & Life Sciences - Other Industry Type: Medical Devices & Equipment Department: Healthcare & Life Sciences Employment Type: Full Time, Permanent Role Category: Healthcare & Life Sciences - Other Education UG: Any Graduate PG: Any Postgraduate Key Skills Analytical skillsTrainingLegalLife sciencesPharmacologyManagementICHData interpretationRecruitment