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Job Details:
Position Name : Senior Clinical Document Specialist
Location: Hyderabad, Telangana
Job ID : 85ac601f8d538eac
Description : 100,000 and more! That’s how many patients are treated in our studies. And every year, 3 million documents are uploaded in the electronic Trial Master Files to preserve the story of the study and ensure innovative medicines can reach even more patients worldwide. But in this world of digital and technological transformation, we must also continue to evolve our approaches to clinical document management and unleash the power of information from this expanding universe of data.
Your responsibilities include, but are not limited to:
Support the clinical trial teams (CTT) in ongoing trial master file review and management; Provide clinical documentation support like -Generation, completion and finalization of all the Clinical Study Report (CSR) Appendices that the Study Lead is responsible for, for all assigned trials;
eTMF tracker/eTRAC reconciliation for CSR appendices and financial disclosure reporting – tracking, reconciling and follow up for essential TMF documents for all sites/investigators (supports completion of CSR appendices 16.1.3 and 16.1.4), for all assigned trials and completing eCTD trackerEOT Checklist completion – Generation, population and follow up for finalization of the check-list to confirm and allow formal close-out of the trial.
Support initial TMF inventory check, mapping, review and gap analysis for ongoing/completed studies transitioned from other sponsorsSupport the study teams in inspection/audit preparation and CAPA closure; Any other document support identified for the role, as agreed/approved
Extensive knowledge and application of ALCOA+ standard, Good Clinical Practice, Good Documentation Practices, and International Council for Harmonization E6(R2) guidelinesWorking knowledge of clinical research documents; Strong TMF Reference Model and eTMF system experienceKnowledgeable in domestic and global regulatory requirements and guidance; Working knowledge of Regulatory Agency Audits and NDA/MAA submission triggered Inspections preferred
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Minimum requirements
An advanced (Masters) degree or equivalent qualification. Working knowledge of the various types of clinical documents. Good understanding of the clinical drug development process and Good Clinical Practice; Excellent word processing skills with advanced MS Word, excel and power point skills
Good knowledge and application of ALCOA+ standard, Good Clinical Practice, Good Documentation Practices, and International Council for Harmonization E6(R2) guidelines
Experience in working with eTMF system experience and understanding of TMF Reference Model preferred, Knowledgeable in domestic and global regulatory requirements and guidanceExcellent written and oral communications and stakeholder management skills. Excellent influencing, negotiating and problem-solving skills.Minimum 5 years pharmaceutical / biotechnology industry experience. Minimum 3 years records management experience in a GCP-regulated environment and with
Strong interpersonal skills and ability to manage all levels within a cross-functional organization through inspiration and influenceContinuous improvement mindset and ability to function independently with a proactive, self-starter attitude
WHY NOVARTIS
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what’s possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Join our Novartis Network : If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Division
Global Drug Development
Business Unit
GDO GDD
Country
India
Work Location
Hyderabad, AP
Company/Legal Entity
Nov Hltcr Shared Services Ind
Alternative Country 1
Ireland
Alternative Country 2
United Kingdom
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
No
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