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1.0 - 6.0 years
2 - 6 Lacs
Bengaluru
Work from Office
Novo Nordisk Global Business Solutions (GBS) India Department – Centralised Monitoring Unit (CMU) Does your motivation come from challenges and working in a dynamic environmentDo you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essentialDo you have a can-do attitude with continuous improvement as one of your career objectivesThen we might have the right position for you. Apply now and join a growing team, working in an international environment. About the department The Centralised Monitoring Unit (CMU)- Bangalore, is a department within the Clinical Drug Development area. It is a perfect blend of skilled medical professionals (Me...
Posted 4 months ago
1.0 - 4.0 years
1 - 4 Lacs
Kolkata, West Bengal, India
On-site
What you will be doing: Annotate Biology-related data to improve AI comprehension. Provide feedback on AI-generated responses to ensure scientific accuracy. Assist in developing problem sets and solutions for AI training. Collaborate with AI researchers to refine AI capabilities in the field of Biology. Must Required Traits: Strong academic background in Biology. Experience in Biology education, research, or content creation preferred. Familiarity with AI, machine learning, or data annotation is a plus. Excellent problem-solving and analytical skills.
Posted 4 months ago
2.0 - 7.0 years
2 - 7 Lacs
Bengaluru, Karnataka, India
On-site
Serve independently as a Clinical Data Coder and/or Lead Coder or DOC for one or more protocols. Manage delivery of coding activities and/or stand alone coding projects through full study life-cycle (with minimal guidance). Validates/tests the coding application and programming of coding reports may also test coding related datasets, coding related edits or any coding related programming activities. Perform comprehensive data management and coding related tasks including, conducting data review and writing and resolving data clarifications. Manage coding related project timelines with guidance from the DOC or Data Team Lead (DTL) or Manager. Perform Serious Adverse Event (SAE) reconciliation...
Posted 4 months ago
5.0 - 8.0 years
4 - 8 Lacs
Bengaluru
Work from Office
Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Sr Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 5 to 8 years Language - Ability: English(International) - Expert About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What woul...
Posted 4 months ago
4.0 - 8.0 years
3 - 7 Lacs
Akola
Work from Office
Role & responsibilities Responsible for following activities: a. Verify cGMP, GDP, GLP and data integrity practices, compliance in Quality Control and microbiology laboratory. b. Review of Specification, Standard test procedures and test data sheet for adequacy and accuracy. c. Review Validation and calibrations of all Instruments. d. Review of AMV, AMT Protocols and reports. e. Handling of Lab incidents, Deviations, OOS, OOC, OOT etc. f. Handling of reserved sample of finished products and its visual inspection. g. Review of trend data of environmental monitoring, water analysis. h. Participation in audit the contract testing laboratory. Preferred candidate profile ERP/ QMS/QC software syst...
Posted 4 months ago
5.0 - 10.0 years
10 - 15 Lacs
Mumbai, Maharashtra, India
On-site
Outpace Consulting Services is seeking a Medical Writer specializing in Life Sciences and Clinical Studies for a leading ITES company. This role is responsible for developing clear, accurate, and well-structured medical and scientific documents for various audiences, including regulatory authorities. You'll translate complex clinical and scientific data into understandable content for regulatory submissions, clinical trial documentation, and other critical materials. The ideal candidate will have strong writing skills, a solid understanding of medical terminology and research practices, and experience with regulatory submission formats. Key Responsibilities: Clinical Document Preparation: Pr...
Posted 4 months ago
6.0 - 11.0 years
25 - 30 Lacs
Bengaluru
Work from Office
Corporate Title: Assistant Vice President To comply with both US and Global regulations, the Financial Market Infrastructure (FMI) Operations team must ensure there are Contingency Strategy (CS) documents in place for all material relationships held with FMIs and Agent Banks, to support continued access to key services in a stress scenario. The CS document describes the actions which could be taken by the FMI and how the DB Group could respond, ahead of and during resolution. To determine which relationships require a CS, an annual global data collection is coordinated by the FMI Operations team, which drives a materiality assessment to determine the key relationships for the DB group. The c...
Posted 4 months ago
3.0 - 6.0 years
3 - 6 Lacs
Bengaluru / Bangalore, Karnataka, India
On-site
Eurofins Scientific is an international life sciences company that provides a wide range of analytical testing services to clients across multiple industries. From food and pharmaceuticals to environmental and cosmetic products, Eurofins ensures safety, authenticity, and accuracy. With a global presence and over 900 laboratories, Eurofins is a leader in food, environmental, pharmaceutical and cosmetic product testing, as well as in genomics, clinical studies support, and other specialized diagnostic testing. Position Summary: Ensuring that the client receives quality data by reviewing laboratory data for accuracy, clarity, and adherence to GMP and/or GLP regulations Essential Duties and Resp...
Posted 4 months ago
7.0 - 10.0 years
6 - 16 Lacs
Mumbai
Work from Office
At Burns & McDonnell India (BMI OGC), you'll be joining the ranks of our Piping Design & Engineering team. You'll report to department & functional managers, and your focus? The engineering design of projects spanning across sectors such as Oil, Gas, Chemicals, Petrochemicals, Renewable Fuels, Decarbonization, and Carbon Capture. And these projects aren't limited to a local scale; they are positioned globally, reflecting our worldwide impact. You'll be a part of our vibrant Oil, Gas, and Chemicals (OGC) Global Practice, a thriving collective of around 500+ professionals. This dynamic group lives and breathes engineering, procurement, and construction projects across various industries - Refi...
Posted 4 months ago
5.0 - 8.0 years
4 - 7 Lacs
Mumbai, Tarapur, Vasai
Work from Office
Experience of reviewer data review of method validation. Document review like STP, Protocols and Reports of AMV , verification. Monitoring of daily activities Preparation and review of Validation Protocol, Report, SOP and Specifications, analysis.
Posted 4 months ago
8.0 - 10.0 years
10 - 12 Lacs
Bengaluru
Work from Office
Position Summary: Ensure the client receives quality data in a timely manner by reviewing laboratory documentation, generated data, calculated results, and final reports for accuracy, clarity, and adherence to GMP and/or GLP regulations, and evaluating problems/system failures to achieve efficiency gains Essential Duties and Responsibilities: Applies GMP/GLP in all areas of responsibility, as appropriate Demonstrate and promote the company vision Regular attendance and punctuality Processing of simple and complex routine and non-routine data (for 3 or more areas) according to departmental, corporate, and client SOPs; read and understand analytical procedures; make sure all work is performed ...
Posted 5 months ago
7.0 - 11.0 years
9 - 13 Lacs
Bengaluru
Work from Office
Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs Specialist Qualifications: Bachelor of Pharmacy Years of Experience: 7 to 11 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the pa...
Posted 5 months ago
3.0 - 5.0 years
2 - 6 Lacs
Bengaluru
Work from Office
Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 3 to 5 years Language - Ability: English(International) - Expert What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabli...
Posted 5 months ago
3.0 - 5.0 years
0 - 3 Lacs
Bengaluru
Work from Office
Clinical Data Analyst Location: Bangalore, Hyderabad, Mumbai Education: Science Graduate Experience: 3+ years Notice Period: Immediate Joiners Preferred Skills: SQL, SAS, MACROS, Lifesciences, Clinical domain, Clinical trials, data reporting/review
Posted 5 months ago
6.0 - 8.0 years
6 - 9 Lacs
Bengaluru
Work from Office
Data Analyst II Job Description Manage data cleaning activities for specified clients/studies Liaise directly with client/CRO DMs to develop a query management strategy during study start-up Enact and maintain data cleaning schedule in accordance with the established query management strategy ¢ Maintain visibility to data lock schedules and ensure reconciliation is complete prior to data lock periods ¢ Ensure a seamless communication and follow up with our selected external client and internal clients. ¢ Analyze client data discrepancies. Update database accordingly to the clients needs and in compliance with the GCP rules when appropriate. ¢ Lead the communication with the other departments...
Posted 5 months ago
11 - 15 years
10 - 15 Lacs
Chennai
Work from Office
Review and approval of analytical documents generated in the QC lab (e.g., STPs, COAs, protocols, reports). Perform thorough investigations related to out-of-specification (OOS), out-of-trend (OOT), deviations, and laboratory incidents in coordination with QC. Ensure timely closure of investigations with proper root cause identification and implementation of CAPA. Ensure compliance with cGMP, ICH guidelines, and other regulatory requirements. Support data integrity initiatives and audit readiness in the QC laboratory. Participate in internal and external audits, including those by USFDA and other regulatory bodies. Review and trend analytical data to ensure ongoing process verification and p...
Posted 5 months ago
7 - 11 years
3 - 7 Lacs
Bengaluru
Work from Office
Skill required: Clinical Data Services - Clinical EDC Build Designation: Clinical Data Svs Specialist Qualifications: BSc/Master of Pharmacy Years of Experience: 7 to 11 years Language - Ability: English(International) - Expert What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them...
Posted 5 months ago
5 - 8 years
4 - 8 Lacs
Bengaluru
Work from Office
Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Sr Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 5 to 8 years Language - Ability: English(International) - Expert What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - ena...
Posted 5 months ago
5 - 8 years
7 - 10 Lacs
Bengaluru
Work from Office
Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Sr Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 5 to 8 years Language - Ability: English(International) - Expert What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - ena...
Posted 5 months ago
2 - 4 years
3 - 6 Lacs
Pune
Work from Office
Preferred candidate profile Looking for a candidate with 2 to 4 years of work experience as QC analyst /AQA reviewer in reputed pharma companies. Should have Knowledge of handling/analytical data review of HPLC, FTIR, UV spectrophotometer, KF Autotitrator, Dissolution apparatus. Have Basic knowledge of CGMP, GDP, Data integrity. Should have Basic knowledge of OOS (Out of specification), OOT (Out of rend), OOC (Out of calibration).
Posted 5 months ago
5.0 - 10.0 years
6 - 9 Lacs
alathur, chennai
Work from Office
Role & responsibilities Review and approval of analytical method transfer / validation protocols and reports. Review and approval of specifications, Methods, Master list and any other Master documents as applicable. Review of Executed analytical documents from Quality control and Analytical Research Development. Preparation, Review, and approval of Standard operating procedures. QMS: Handling of Events, Change controls, CAPA, Customer complaints, Product Recall, OOS and any other QMS elements. Timely completion of Assigned QMS elements on or before the due date. Preferred candidate profile Ready to relocated chennai location
Posted Date not available
2.0 - 7.0 years
10 - 14 Lacs
bengaluru
Work from Office
About The Role Position Summary: Ensuring that the client receives quality data by reviewing laboratory data for accuracy, clarity, and adherence to GMP and/or GLP regulations Essential Duties and Responsibilities Applies GMP/GLP in all areas of responsibility, as appropriate Demonstrate and promote the company vision Regular attendance and punctuality Read and understand analytical procedures Review documentation, generated data, calculated results, and final reports according to departmental, corporate, and client SOPs Gain a technical understanding of the techniques in which review is being performed Use MS Windows applications such as EXCEL, Word, Access, Outlook email Conducts all activ...
Posted Date not available
0.0 - 5.0 years
1 - 1 Lacs
gurugram
Remote
Any Regional Language Mandatory (Gujarati, Marathi, Bengali, Tamil, Telugu, Kannada, Malayalam, Oria) Flexible with Rotational Shift Rotational week off Laptop, Wi-Fi, Power Back up Mandatory Immediate Joiner Understanding of Data of social Media
Posted Date not available
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