A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post: Clinical Research Specialist
Job Description:
Support the clinical trial team (CTT) in the administrative coordination of trial activities through specific tasks, including but not limited to budget, document management, drug supply, trial master file, and archiving, preparation of selected clinical study report (CSR) appendices, and provide overall support to the CTMR department, as assigned.
1.Budget responsibilities: Track, verify, and reconcile vendor invoices with actual work performed for payment
2.Document management: Coordinate and maintain records to track flow of life cycle management in the document management system for appropriate assigned document (i.e., Vendor Activity Worksheet). Ensure the business process for review and approval of documents is adhered to.
3.Drug Supplies:
a.Collect and verify the drug batch information received per patient for CSR appendix documentation for trials without IVR tracking
b.Verify at the global level for re-supply needs for all study drugs at the CPOs for trials without IVR tracking
4.Tracking and archiving:
a.Responsible to set up and maintain HQ Trial Master Files (TMF) and ensure files are complete for each study center according to Novartis SOPs and guidelines.
b.Track IRB/EC approvals dates and addresses for protocols and amendments
c.Using the Novartis tracking tool, track receipt of documents from the field and verify completeness of documents for HQ TMF (e.g., tracking of FDA form 1572, financial disclosures, and CVs for CSR appendices)
d.Interact with clinical team members, field monitors, and other study team personnel to resolve issues with missing, incomplete, misfiled documents
e.Support archiving of required trial information (i.e., investigator meeting presentations, study correspondence) and posting of study documents (ensuring correct format and naming con-ventions) as directed by the clinical team
5.Clinical Documents:
a.Responsible for FPP process
b.Support the appendices preparation for the CSR completion
c.Verify that study documents (i.e., protocols, amendments, TOOs and CSR appendices) are correctly filed in CREDI; support completion of submission eTMF tracker
d.Ensure correct eCTD file naming convention for reference finalization in document manage-ment systems (e.g. CREDI )
e.Insert active hyperlinks within Regulatory documents, QC of hyperlinks in clinical documents to ensure accuracy
f.Interface with document publishers on behalf of clinical teams to ensure availability of ‘pub-lished’ quality documents that are delivered according to timelines and technical specifica-tions.
g.Support collection of published scientific references and import into CREDI ensuring correct format and naming conventions in support of the preparation of various clinical submission documents (e.g., expert statements, clinical overview, Annual Safety Report)
Minimum requirements:
An advanced (Masters) degree or equivalent qualification or work experience is required 0-2 years English (oral and written)
1. Excellent word processing skills with advanced MS Word are required
2. Proven experience working with computers
3. Experience working with the documentation system
4.Strong intrapersonal skills, customer focused, and ability to work independently managing multiple priorities across a glob-al organization
5. Well-organized, detail oriented and excellent follow-up skills
6. Good oral and written communication skills are required
7. Working knowledge of the various types of clinical documents is helpful
8. Basic understanding of the clinical drug development process, Good Clinical Practice and familiarity with medical terminolo-gies is a plus
Additional Information:
Experience:0-2 years
Education: Degree
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Research & Development
Division: PHARMA
Job Type: Full Time
Location: India
Job ID: 190324BR
End Date: 21st July, 2016
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