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: Sr. Analyst - Laboratory Management
Job Description:
• Manages local lab reference ranges and units for safety and specialty labs within and across projects, ensures plausibility/completeness of ranges/units/conversions and interacting with CTT and/or querying as necessary. Involved in review of study-level database setup for collection and edit checks on local lab data, ensures that the designs for lab-related CRF standards are scientifically appropriate and sensible. Provides support for DM review and follow-up of issues in lab results data. Escalates issues that cannot be resolved and have the potential to impact the quality of deliverables to the Group Head and affected study team.Managed local lab reference ranges, ensuring the scientific validity of ranges, units, and conversion algorithms for each lab parameter and age/sex grouping.
• Manages and performs processes for entry and/or uploading of local lab reference ranges into the lab management sub-systems, taking into account current group pri-orities, volume of requests, and upcoming study milestones.
• Troubleshoots questionable ranges, units, parameter test names, conversion algorithms and other details related to local lab reference ranges and/or data.
• Interacts with CRAs, TDMs, and other Clinical Trial Team members as appropriate to develop appropriate study level CRFs, CCGs, edit checks, etc, and ensure the quali-ty/completeness of local lab reference ranges and results data.
• Reviews lab results data and queries sites/CRAs as appropriate to ensure high quality data is achieved prior to each database deliverable.
• Collaborates on the development/update of lab-related training materials, instructional documentation, and reference materials
Candiate Profile:
• University or college degree in life science, chemistry, pharmacy, nursing, or equivalent relevant degree English (oral and written)
• 2 or more years of relevant experience in a medical laboratory or patient care setting, plus a minimum of 4 or more years of experience in drug development and at least 3 years managing data.
• Strong understanding of all commonly used safety lab parameters including specialty assessments such as cardiac enzymes, tumor markers, hormonal studies, etc… as well as haematology, blood chemistry, and urinalysis
• Excellent attention to detail.
• Strong communication, problem-solving, negotiation and conflict resolution skills
• Ability to prioritize own work and resolve common problems independently, deal effectively with vol-ume/deadline pressure, and demonstrate flexibility in an environment where priorities change frequently.
• Strong understanding of clinical trials methodology, GCP and medical terminology.
Additional Information:
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: R&D
Location: Hyderabad
Job ID: 182245BR
Last date: 5th March, 2016
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