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 Trial Specialist
Job Description
1. Interface with document authors and make editorial changes (nonscientific or very minor scientific) to documents as appropriate to ensure technical compliance.
2. Maintain records (logs) to track the flow of documents that are pushed through documentum lifecycle. Ensure the business process for review and approval of documents is adhered to.
3. Provide support to Franchise associates in the use of Novstyle, including training. Trouble shoots problems and is a liaison between the Franchise and CREDI help desk. Serve as CREDI LUDA (Line Unit Document Administrator).
4. Insert active hyperlinks within documents, ensuring hyperlinks are accurate
5.Interface with document publishers on behalf of clinical teams to ensure availability of quality documents that are delivered according to timelines and technical specifications.
6. Responsible to set up and maintain Trial Master Files and ensure files are complete for each study center according to Novartis SOPs and guidelines. Liaise with country organization representatives to obtain missing, incomplete or illegible documents (i.e. Investigator CV, FDA 1572, financial disclosure). Support archiving of required trial information (i.e., investigator meeting presentations, study correspondence) and posting of study documents as directed by the clinical team.
7.Ensure timely posting and updates of trial information in required registries (e.g., Clintrial.gov, trial results database) according to guidelines
8.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) 9.Perform specified quality checks on clinical documents, including performing technical cross-checks between various sources of information (e.g., clinical study report narratives are checked against database reports, in-text data is consistent with table content)
10.Support the ongoing review of clinical trial data and perform specified quality checks. Take corrective action as necessary.
11. Generate specified clinical trial tracking reports to assist teams with monitoring progress of trials (e.g., site initiation, patient recruitment, data management
12.Coordinate clinical trial scale activities (e.g., copyright authorization, translations, certifications) and related patient diary ensuring availability for trial start.
Candidate Profile
A bachelor’s degree or equivalent qualification or work experience is required English Excellent word processing skills with advanced MS Word are required.
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Proven experience working with computers Experience working with the documentation system.
Strong intrapersonal skills, customer focused, and ability to work independently managing multiple priorities across a global organization.
Well-organized, detail-oriented and excellent follow-up skills Good oral and written communication skills are required Working knowledge of the various types of clinical documents is helpful.
Basic understanding of the clinical drug development process, Good Clinical Practice and familiarity with medical terminologies is a plus.
Additional Information:
Job ID: 141636BR
Industry Type: Pharma/Biotech/Clinical Research
Location: India
Functional Area: Other
End Date: 25th May, 2014
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