Data Analyst

Data Analyst JOB-804 Department: Supervisor: Classification: Job Description –Data Analyst www.lndiagelatine.com Document Type: Job Description Bengaluru, Karnataka, India. Operation Department Operation Manager, Department Head Internal Posting Rev 1 Purpose and Scope TheDataAnalystwillberesponsibleforallaspectsofthedatamanagementfunctionduring planning, execution,andcompletionofaclinicalstudyphases.Thiswillincludebutisnotlimitedtothe designofthe most efficient way to collect the data, data management and analysis, and results write-up. It will also involve the proactive work with Key Opinion Leaders (KOL) to assist with abstracts and publications preparation, as well as support of Marketing Affairs with varied commercial tools development. This position will require flexibility with changing priorities based on the study and/or Clinical Affairs needs. Primary Organization Responsibilities • Responsible for the management of all data management activities. o Designs data collection tools (case report forms, electronic data capture capabilities, etc.). o Defines and verifies correct functionality of automated edit checks against protocol requirements, etc. o Performs data review regularly and generates queries against data discrepancies to ensure data accuracy. o Tracks outstanding data issues and queries to ensure correct and timely resolution. o Works closely with the clinical study team and monitoring group to identify and communicate data trends and potential compliance issues. o Creates data validation plans and performs data validation. o Performs database training with site and sponsor personnel. o Manages required regulatory documentation in regards to study data compliance, as directed. • Responsible for proactively managing and identifying data trends. o Tracks and follows up with sites regarding outstanding data issues. o Provides data-related support for study-related meetings. o Based on data trends, suggest changes to the forms, processes, etc. to increase business efficiency. • Assists with study reporting, (e.g. annual progress reports, DMC, other required FDA reports) as needed. • Accountable for data analysis and write up (explanation of the data) for abstracts and manuscripts. o Possesses the technical expertise to create datasets (e.g., by merging data tables as needed) and perform basic analysis of the data while working closely with statistician(s) to complete more complex analyses. o Assist KOLs with abstracts and publications preparation. o Identifies abstract/publication ideas based on the data available (Monteris data vs. competitors data vs. other scientific data available). o Assists Marketing Affairs with varied commercial tools development. • Develops and maintains Clinical Data Management Plans as well as all Statistical Analysis Plans. • Performs other duties as directed or assigned. • Development of formulation using scientific rationale in use of excipients to create a reproducible prototype formulation • Conduct literature search and draw relevant conclusions which would help in formulation design and development. Perform pre-formulation study whenever required and market sample evaluation. Gelatine India Private Limited - Mumbai, India Page 1 of 2 JOB-804 Job Description –Data Analyst Rev 1 • Ensure Proper documentation of every trial in the log note books and then using the information for creation of the Product Development Report for use in dossier for filing • Development trials for solid, liquid, semi-solid formulations at R&D, third party site & various flavour houses • Use of QbD wherever required for Product and process optimization • Ensure scale up of the developed formulation works at engineering batch level • Stability charging and evaluation of stability results as per ICH • Technology transfer and scale-up batches of all formulations at unit • To follow up and to ensure the availability of raw materials, packing materials, equipment and spares required for development work and to manage inventories of supplies, API and raw materials. • Interact with various stakeholders like PM, Finance, Manufacturing, QA, Supply chain, stores and marketing to ensure that project is deliverable on time Documentation • To record experiments in ELN • Preparation of stability protocol • Compilation of stability results • Prepare manufacturing trial documentation for pilot / small production runs and scale-up operations. • Develop/review FPS, PDCL, PAF and other documents • To generate material code for RM/API/BFG • To prepare and review documents for FRM • To prepare and review MFR and other guidelines • prepare technical documents and Pharmaceutical Development Report. • Reports/Planning • Report on adherence to schedule and trial status on a weekly basis to Product Development Manager. • Plan the trial batches/scale up batches in co-ordination with third party unit Miscellaneous • Adhere to Health & Safety Policies and Standard Operating Procedures IDEAL CANDIDATE PROFILE & DESIRED SKILL SETS • Knowledge in formulation development for FSSAI, Drug, Personal care, Ayurvedic, Herbal products • Must be ready to travel for almost 10-15 days in month. • Hands on experience in formulation development of various dosage forms like Chewing gum, Hard boiled candies, Soft gelatin capsule, Liquid orals in tetra pack as well as PET bottles, Protein powders, cream, lotion, Ointment etc. • Hands on experience in using ELNs & various softwares used IN R &D • Thorough knowledge of FSSAI guidelines. • Pre-formulation study as may be required for formulation development. • Proven working knowledge as a Data Analyst or Business Data Analyst • Technical expertise regarding data models, database design development, data mining and segmentation techniques • Strong knowledge of and experience with reporting packages (Business Objects etc), databases (SQL etc), programming (XML, Javascript, or ETL frameworks)