...lock with the oversight of the LCTL/CTL, as assigned. Support the clinical protocol development process in collaboration with the CTL/Lead... ...with the CRO; Management Department as well as with the Assay Research Lab. This also includes the set-up, logistics, documentation and...
...collected and in alignment with the protocol.
• Support the assessment of new data collection requirements in assigned studies and provide clinical input into the development of new and updated clinical Data Standards (for CRFs as well as 3rd party data collection methodologies)...
About the Role
Principal RWE Research Analyst
Location – Hyderabad #LI Hybrid
About the Role:
The Principal Real World Evidence... ...in a closely related field within the pharma industry (e.g., clinical research, statistics, epidemiology, pricing).
• Master’s degree...
...About the role
“150! Clinical scientific experts, globally, are part of Global Drug Development (GDD) team, working to ensure clinical... ...).
•
1 year experience in pharmaceutical industry/ clinical research organization - Basic knowledge in planning, executing, reporting...
...Translational Medicine (TM), in Novartis Institutes of Biomedical Research (NIBR). It is an enterprise organization, unique within... ...knowledge of pharmacokinetics, pharmacodynamics, metabolism and clinical pharmacology in advancing the drug candidates from discovery and...
...About the role
Senior Clinical Project Manager
Location – Hyderabad #LI Hybrid
About the Role:
Responsible for Clinical execution... ...other clinical services (e.g. managed access programs (MAP), Research Collaborations, IITs, Digital Solutions etc. driven by GBS on...
About the Role
Job Purpose
The Head of Operational Excellence, Clinical Development will be accountable for leading key strategic global operational excellence activities across the CD function. The role will support strategic planning and operational execution in partnership...
...About the role
Clinical Data Scientist
Location – Hyderabad/ Mumbai
About the Role:
Provide timely and professional ongoing management of Data Management deliverables and of clinical trial data with respect to cost, quality and timelines for all assigned trials...
About the Role
Your responsibilities will include, but are not limited to:
• Represents GCS as a core member in the integrated Clinical Trial Team (iCTT); defines and advises the iCTT on the optimal clinical trial supply strategy in terms of, but not limited to, packaging...
About the Role
Manager – Primary Market Research
Location – Hyderabad #LI Hybrid
About the Role:
Be part of a leading healthcare primary market research team working with brand teams across the globe, as part of Novartis’ longer term strategic plan, to bring a new...
...listings and figures for Interventional and Non-Interventional Clinical studies.
Maintain efficient interfaces with other statisticians... ...of/experience with SAS/ R/ Splus or any other business or research analytic software with an expertise in at least one software....
..., coordination, development and timely delivery of high quality Clinical submission documents to Regulatory Affairs (RA) for
1) New Drug... ...healthcare or equivalent with ≥ 2 years’ experience in Clinical research with proven proficiency in global Clinical development.
•...
...Engineer
Location: Hyderabad
Novartis Institutes for BioMedical Research (NIBR) is the global pharmaceutical research organization of... ..., visualization, and interpretation of chemical, biological, clinical and operational data.
Key Responsibilities:
• Develop state...
...is responsible to design and execute data management strategy across Drug Development line functions i.e. Clinical Operations, Clinical Data Standards, Technical Research & Development, Regulatory Affairs and Patient Safety. Function also collaborates with cross domains such...
...scientific/technical studies. By bridging the analytical science to the clinical performance you will drive the transformation of our molecules... ...is based in the Genome Valley, Hyderabad, within the Technical Research and Development Organization (TRD) of Global Drug Development (...
...critical business problems. Understand life science data sources including preclinical, clinical, sales, contracting, promotions, social media, patient claims and Real-World Evidence
• Research and co-develop with supervisor in data management, new algorithms, methods,...
...partner with global stakeholders to provide competitive intelligence research and analysis.
Your Key Responsibilities:
• Provide inputs through secondary data research and creating summaries for clinical and business events (periodic newsletter, news alerts)
• Provide...
...Leader is responsible for the execution and delivery of the Global Clinical Operations (GCO), clinical studies in accordance with the... ...equivalent). 12- 15 years of Industrial experience in Clinical Research or Drug Development in any Phase.
• Significant recent experience...
...and Licensing (BD&L) groups, medical contribution to the overall clinical strategy and individual clinical studies in close collaboration... ...functions e.g. patient safety.
• Identifies and engages with contract research organizations for selected GMD activities; supports Head Global...
...- Exercise Knowledge and Experience in Regulatory Agency Rules and Inspection Protocol as Well as Clinical Chemistry Best Practices to Enable the Most Advanced Research Capabilities Possible in the Laboratory
- Isolate, Analyze and Conduct Diverse Experiments with Proteins...
About the Role
2025! This is the year that Global Clinical supply is targeting for completing the evolution our systems into a “digital... ...from Phase 1 to approval and be a key interface between Technical Research & Development (TRD) teams and the Clinical teams! At GCS, we...
...Millions! Novartis made a decision to pursue early discovery research internally to allow us to quickly translate the most impactful discoveries... ...Data Management team to enable reconciliation for locking of Clinical database. Alert the Medical Safety Physicians of potential...
...ownership experience in a pharmaceutical or healthcare consulting setting, preferably in drug safety (i.e., Pharmacovigilance), clinical research, or regulatory affairs (incl. appropriate business case development)
• Solid knowledge in drug safety related processes (incl....
...Translational Medicine (TM), in Novartis Institutes of Biomedical Research (NIBR). It is an enterprise organization, unique within... ...knowledge of pharmacokinetics, pharmacodynamics, metabolism and clinical pharmacology in advancing the drug candidates from discovery and...
...scientific/technical studies. By bridging the analytical science to the clinical performance, you will drive the transformation of our molecules... ...is based in the Genome Valley, Hyderabad, within the Technical Research and Development Organization (TRD) of Global Drug Development (...
...progress beyond the boundaries of best-in-class Statistical Programming analysis. From a collaborative effort with Data Management, Clinical Study Teams, Statisticians, medical / scientific writing teams, publication teams, we analyze tons of data, deriving meaningful insights...
...managers across 6 countries and support Novartis operational expertise in the mobilization of the organization’s commitment to sharing of clinical trial documentation and datasets. You will collaborate with colleagues from Statistics, Legal, Regulatory Affairs, Data Privacy, Data...
...Independently manage and execute drug shipment ticket review process (US)
• In addition to regulatory manager, provide guidance to clinical functions on regulatory compliance activities, such as requirements for TOOs, VDRs, drug shipment etc.
• Assist regulatory managers...
...relevant work instructions incl. financial risk controls (NFCM)
• Provide process/system expert support & training to all countries having clinical trial activities – Governance over RDF CoE future transitions, KPIs, projects, check-in NFCM controls.
• Support audit reporting...
...Requirement
• Medical Degree (MBBS or MD) required. Medical degree with specialization preferred.
• 3+ years of PV, Medical practice or Clinical Drug Development experience post MBBS.
• Experience in safety document or medical writing including experience coding with MedDRA...