37 Data Review Jobs

You will be responsible for providing highly advanced expert support and functional and technical leadership to ensure the scientific integrity and validity for clinical development, early development, and/or research projects. Your main tasks will include developing and applying biostatistics and programming methods to ensure valid conclusions, as well as providing statistical support for regulatory submissions, including planning, analysis, and reporting of clinical safety and efficacy summaries. Additionally, you may also provide statistical support to research or other R&D areas. To meet challenges in data review, big data, analytics, and reporting of clinical trial data, you may independently provide timely and professional leadership of special projects that focus on innovative tools and systems. You will strategically and tactically support the Director Clinical Data Standards and be responsible for advising/leading the planning, development, and implementation of Industry (CDISC and regulatory) compliant, high-quality clinical data standards, infrastructure, or automation technologies. Your role will also involve providing expert support and stellar customer focus to business users and teams on their use of data standard collection tools, data transfer specifications, analysis data/TFL standards/Define, automation solutions/technologies, and business infrastructure, business rules, and guidelines. You may also lead global teams as required. At the study level, you will be responsible for all statistical tasks on assigned clinical or non-clinical trials, particularly for high complexity trials, seeking peer input/review as required. You will contribute to protocol development, statistical analysis plan development, and reporting activities. Additionally, you will provide statistical expertise to support submission activities and documents, meetings with Health Authorities, pricing agencies, and other drug development activities. You will independently lead interactions with external review boards/ethics committees, external consultants, and represent the organization in statistical discussions at external congresses, conferences, and scientific meetings. You will be responsible for strategic statistical input into one or more projects, collaborating with clinical, regulatory, and other strategic functions to drive quantitative decision-making in drug development. At the disease area/TA/indication level, you will drive strategic statistical input and excellence to development programs within the assigned areas. Additionally, you may lead or significantly contribute to initiatives at the global line function level or cross-functional franchise level, requiring coordination of diverse team members. You will actively contribute to cross-functional organizational/process/scientific consulting improvement initiatives and represent the organization in due diligence teams for in-licensing opportunities. The ideal candidate will have an MS (in Statistics or equivalent) with 10+ years of relevant work experience or a PhD with 6+ years of relevant work experience. Strong interpersonal and communication skills, along with proven expertise in statistics and its application to clinical trials, are essential. Additionally, experience with statistical software packages such as SAS or R, and a strong understanding of drug development and Health Authority guidelines are required. The role may also require expertise in pharmacokinetics, exposure-response modeling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Novartis is committed to providing reasonable accommodation to individuals with disabilities. For more information or to request accommodation during the recruitment process, please contact [email protected] and include the job requisition number in your message.,

The ideal candidate will develop relationships with key accounts to maximize revenue and client retention. You will act as a consultant by developing account strategies that provide the greatest opportunities to drive revenue. You will be responsible for providing general sales support, including needs analysis, data review, and product demonstrations. Additionally, you will serve as the customer advocate and liaison for product management and development. It will be your duty to prepare periodic forecasts and progress updates toward sales goals. To qualify for this position, you should have a Bachelor's degree or equivalent experience in Business. You must have at least 3 years of sales consulting or business intelligence experience. Excellent written and verbal communication skills are a must, along with the ability to multi-task, organize, and prioritize work.,

As a Customer Support Analyst at AGDATA, you will play a crucial role in supporting and managing clients at our brand-new location in Pune, India. Your responsibilities will include transcribing English handwritten documents into a computer system, data cleansing, reviewing, and matching client information using Excel and other tools, as well as effectively communicating with your team and leadership regarding task execution, status, and delivery. The ideal candidate for this position will have 3-5 years of experience in data entry, cleanse, review, and matching, along with proficiency in MS Office and advanced skills in Excel Spreadsheets. A graduate in any stream with relevant experience, you should possess the ability to multitask, set priorities, and manage time effectively. Strong attention to detail, a high aptitude for problem-solving, and experience with Data Cleanse/Data Review/Data Matching are essential requirements for this role. At AGDATA, we prioritize supporting our employees" health and well-being by offering comprehensive medical coverage for employees and dependents, including parents, with coverage of up to INR 7.5 lakh. Additionally, we provide OPD benefit coverage of up to INR 10 thousand, encompassing expenses across specialties, and offer paternity leave of up to 14 working days with the option to split the leave. We believe in fostering a work culture that promotes growth from within, as evidenced by the fact that 14% of our associates were promoted internally in 2023. When you join our team, you can expect to work in a comfortable office environment with brand-new office space, free snacks, and top-class facilities to support your work and well-being. Join AGDATA in our mission to transform the agriculture, crop protection, specialty chemical, and animal health industries by providing innovative data and marketing solutions. Apply now to be a part of our dynamic team and contribute to our continued success.,

You will serve as a member of the project team, primarily responsible for clinical data review, query generation/resolution, and reconciliation to ensure the delivery of clinical data meets client quality and integrity specifications, project timelines, and productivity targets. You may also assist in developing project Data Management Plans and setting up data management systems as per project requirements. Additionally, you may lead data management activities on small projects with technical oversight. Your responsibilities will include reviewing clinical trial data based on Data Management Plans and standardized processes to identify errors or inconsistencies, running ancillary programs to support data review, generating and resolving queries, performing aggregate data reviews, ensuring data quality standards are met, reviewing project documents, collaborating on Data Management and Quality Management Plans, reviewing database design, creating data review guidelines, developing data management system checks, assisting in building timelines, and ensuring service and quality standards are achieved. To qualify for this role, you should have a university/college degree in life sciences, health sciences, information technology, or related subjects. Alternatively, relevant work experience may be accepted in lieu of a bachelor's degree. You should have 4 to 6 years of experience in Clinical Data Management, knowledge of clinical trial processes, time management skills, ability to work in a team environment, good organizational, communication, and interpersonal skills, as well as knowledge of medical terminology and science. Preferred qualifications include thorough knowledge of Fortrea, Electronic Data Capture experience, and familiarity with organization SOPs. You will primarily work in an office or home-based environment. Additionally, you may need to support and action client or internal audits, mentor/coach project staff, and perform other related duties as assigned by management.,

As a part of this role, you will be responsible for sample preparation, daily calibration, and the maintenance of equipment, including keeping a detailed log of all activities. You will also be involved in method development, method validation, and conducting sample analysis in accordance with ICH M10 guidelines. Operating, maintaining, and calibrating LCMS equipment will be a crucial part of your responsibilities. In addition, you will be required to adhere to documentation procedures as outlined in Bio analytical SOPs and ICH M10 guidelines. This will involve thorough record-keeping and ensuring all documentation is accurate and up to date. Furthermore, you will be expected to review data and reports to ensure quality and compliance with relevant standards. Your attention to detail, ability to follow guidelines meticulously, and commitment to maintaining accurate records will be essential for success in this role. If you are looking for a position that offers diverse responsibilities in a dynamic environment, this opportunity may be the perfect fit for you.,

As a Data Management Specialist, your responsibilities will include defining project specifications for Data Management services such as Protocol Conversion, Database Build, CRF Design, and Data Review and Data Reconciliation tools. You will need to have a clear understanding of external data collection, its integration into clinical trials, and the processes required for management and reconciliation to maintain accuracy and relevance. Your role will involve executing data cleaning strategies to expedite subject data cleanliness and ensure the delivery of high-quality and timely outcomes. You will be responsible for conducting holistic data review and trending analysis through reporting and elluminate analytics to proactively identify issues, risks, and develop effective mitigation strategies. Utilizing artificial intelligence (AI) and machine learning (ML) for anomaly and outlier detection will be a key aspect of your responsibilities to enhance the efficiency and quality of trial data. Monitoring and interpreting key performance indicators (KPIs), metrics, dashboards, Clinical Trial Operational Analytics (CTOA), and reports will enable you to provide actionable recommendations to study leads or project managers. You will be involved in query management, defining specifications, and collaborating with the technical team on configuring a centralized data management platform, elluminate Data Central for data cleaning strategy and oversight activities. It will also be essential for you to prepare and maintain data management documentation and update them throughout the trial lifecycle. Ensuring the quality control of team-developed deliverables, covering eCRFs, study documents, program/report specifications, outputs, and elluminate Data Central with analytics modules will be part of your role. You will actively evaluate and contribute to enhancing processes to increase efficiency and effectiveness. Collaboration and teamwork are crucial in this role to ensure that deliverables are completed on time and with high quality. Compliance with industry quality standards, regulations, guidelines, and procedures will also be a key focus, along with any other duties as assigned.,

You will be responsible for performing chemical and instrumentation analysis on various materials including in-process, raw materials, packing materials, intermediates, and finished products. Your primary goal will be to ensure compliance with dispatch timelines as per the monthly schedule provided by PPL. Your duties will include conducting instrumentation analysis using ICP-MS and LC-MS for the mentioned materials to meet dispatch timelines. Additionally, you will be involved in analytical method developments, validations, transfers, and verifications using ICP-MS and LC-MS/MS. You will be required to prepare and review protocols, worksheets, and reports for method developments, validations, verifications, and transfers. Allotting work to chemists within the section, calibrating instruments, maintaining documentation online, and ensuring minimum stock levels for various materials and standards will also be part of your responsibilities. Monitoring and reviewing analytical data, calibration data, and qualification data, as well as ensuring instruments are calibrated and maintained in working condition, will be crucial tasks. You will also play a key role in reducing lab incidences, implementing CAPA, and maintaining safe working conditions. Collaboration with QA, Production, PPIC, Warehouse, and TSD for smooth dispatches, as well as training employees on GLP/GMP and coordinating with external laboratories, will be essential aspects of your role. Your commitment to data integrity, timely analysis and release of batches, cost control, and adherence to safety practices will contribute to the overall success of the team. This position requires a Bachelor's degree and offers an opportunity to work with Piramal Pharma Solutions (PPS), a Contract Development and Manufacturing Organization (CDMO) known for its end-to-end development and manufacturing solutions across the drug life cycle. PPAs serves customers globally and provides a wide range of services, making it a preferred partner for innovators and generic companies.,

Role primarily focuses on financial modeling, financial planning, and providing strategic support to other team, forecasts, and data-driven insights to guide business decisions. Support the consolidation of financial data from various departments for review and analysis. Prepare monthly and quarterly financial reports, highlighting key performance metrics. Maintain and update financial models to support decision-making processes. Conduct scenario analysis to assess financial impact of business decisions. Assist in preparing Credit Monitoring Arrangement (CMA) reports for raising term loans and working capital loans. Collaborate with Treasury team by providing relevant financial data required by banks and financial institutions. Utilize tools like Power BI and Excel for advanced data analysis and visualization. Support the finance team in ensuring compliance with financial regulations and internal controls. Assist in audit preparations and coordinate with external auditors as required.

You should have 2-4 years of relevant experience in producing periodic accurate and timely Client Reports and Presentations across multiple investment strategies for an Asset Manager or Bank. Your responsibilities will include working with others to draft Requirement Documents, review data sets, source data accurately, standardize data for consistency, create reporting templates, perform testing, and implement suitable reporting templates in a timely manner. You must have a proven working knowledge of client reporting platforms, processes, internal and external data providers, and a strong sense of risk mitigation. Coordinating information flow between relevant internal business areas to ensure accurate and timely completion of reports is crucial. Additionally, you should continuously maintain reporting templates, suggest ways to check for data issues and resolve them, manage project timelines, support functional testing, and deployment. Experience in MS Excel, MS Power Query / BI, automation software like Alteryx, SQL, Simcorp Coric, object-oriented programming, TFS, .NET, C#, and understanding of performance principles and calculations is required. Your role will involve creating and maintaining SOPs, risk logs, BCP, suggesting and implementing tools to automate and optimize reporting workflows, and resolving automation issues. You should have excellent communication and interpersonal skills, be highly motivated, independent, have a strong interest in solving complex problems, and be able to manage projects and deadlines effectively. Maintaining strong working relationships with external/internal clients and responding to queries in a timely manner is essential.,

Strong 1-4 years of knowledge and Experience in Analytical QA

You should have 2-4 years of relevant experience in producing periodic, accurate, and timely client reports and presentations across multiple investment strategies regularly for an asset manager or bank. It is essential to have a proven working knowledge of client reporting platforms, processes, internal and external data providers, coupled with a strong sense of risk mitigation. Your responsibilities will include working with others to draft requirement documents, reviewing data sets and flows for suitability and quality, accurately sourcing data, standardizing data for consistency, creating reporting templates with accurate configurations, performing functional/integration testing, and implementing suitable reporting templates in a timely manner. Coordinating information flow between all relevant internal business areas to ensure all allocated reports are completed accurately and promptly is crucial. You will need to continuously maintain reporting templates to ensure they are operating efficiently and fit for purpose. Identifying and resolving data issues promptly is essential. Managing project timelines, supporting functional/integration testing and deployment, creating and maintaining SOPs, risk logs, and BCP are also part of your responsibilities. Proficiency in MS Excel, MS Power Query/BI, automation software like Alteryx, and SQL is required. You should be able to suggest and implement tools to automate and optimize reporting workflows and mitigate risks. Experience with Simcorp Coric, object-oriented programming, TFS, .NET, and C# would be highly beneficial. A strong understanding of the end-to-end process of data collection, data review, and report production, including performance principles and calculations, is essential. You should demonstrate an understanding of how incorrect data points can impact reporting. Excellent communication and interpersonal skills, along with a command of English, are necessary. You must be highly motivated, independent, have a strong interest in solving complex problems, and demonstrate a proven ability to manage projects and deadlines effectively. Maintaining strong working relationships with all external/internal clients, ensuring clear and accurate communication, and responding to queries promptly are critical aspects of this role.,

- Understand and follow study start-up, conduct, and close out activities per the standard process, which will be made known to Service Provider and to the Data Manager in advance and in writing by Baxter. - Act as a single point of contact from the Service Provider for the studies as assigned - Prepare/review eCRFs, Edit checks, and Custom Functions requirement document - Prepare or review edit checks requirement and functional test script document - Perform functional testing for eCRF/edit checks and Custom Functions - Identify reports and DM Tables requirements and prepare a report specification document - Review and provide feedback for study conduct activities performed by the Service Provider peer data reviewer as and when required - Train Study Team / Sites on EDC - Perform Query management and manage manual edits checks follow-up messages, etc. - Performing AE reconciliation and preparing material for AE reconciliation meeting and schedule it - Provide inputs to Data Review Plan.

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 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 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 worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.You will be expected to develop and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for Adaptable and flexibleAbility to perform under pressureProblem-solving skillsDetail orientationAbility to establish strong client relationship Roles and Responsibilities: Data Review Report Programmers:Overall experience of 4+ years in Clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred.Participate in the lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support.Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders.Facilitate interaction with end user on creating specifications and working with programmers or performing the programming activities for successful delivery.Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred. Qualification BSc,Master of Pharmacy

Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs Specialist Qualifications: Bachelor of Pharmacy Years of Experience: 7 to 11 years 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 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 worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. The role may require you to identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The role may also need expertise in managing clinical data management projects. What are we looking for Adaptable and flexibleAbility to perform under pressureProblem-solving skills Roles and Responsibilities: Overall experience of 4+ years in Clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred. o Participate in the lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. o Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders. o Facilitate interaction with end user on creating specifications and working with programmers or performing the programming activities for successful delivery. o Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred. o Good analytical and communication skills. Qualification Bachelor of Pharmacy

Responsibilities: * Lead QMS implementation & compliance * Ensure product quality through data review & annual product quality reviews * Conduct BMRRs, batch releases & equipment qualifications Office cab/shuttle Provident fund

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 (Medical reviewers) and technical programmers (Functional programmers, statistical monitors). Medical reviewers are actively involved in Risk-based medical monitoring in collaboration with the medical specialists from Denmark, with a focus on ensuring overall patient safety and wellbeing of all clinical trial participants, by ensuring compliance to protocol and identifying potential clinically significant outliers that require medical attention and medical data cleaning. The Functional Programmers develop operational visualizations in data visualization tools to support the trial teams on proactive centralized monitoring and Statistical Monitors perform the detection of unusual data patterns, systematic errors, and potential lack of compliance or fraud across trials. The Position (NoteThis is not a role within Pharmacovigilance) The Senior Medical Reviewer is responsible for conducting comprehensive medical reviews of clinical trial data across various therapy areas within the drug development portfolio. This role ensures the highest quality and consistency of medical data, with a strong emphasis on patient safety, protocol adherence, and compliance with Good Clinical Practice (GCP), ICH guidelines, local regulations, and Standard Operating Procedures (SOPs). Key responsibilities include collaborating closely with study team members—such as Data Managers, Trial Managers, and Medical Specialists—throughout the trial process, providing timely updates on the status of medical reviews, and escalating any issues to maintain trial integrity and compliance. Responsible for contribution to or participation in trial planning activities related to medical review. Perform the quality check measure for the medical review. Responsible for clarifying and if possible, resolving issues of medical concern and inconsistencies in clinical trial data with staff at investigational sites. Responsible for presenting findings of Medical Review to relevant Medical Specialists to enable decision-making. Responsible for documenting medical reviews in the sponsor TMF. Ensure close collaboration with relevant study group members, especially the Data Manager, Trial Manager(s), and Medical Specialist during trial conduct. Provide training on the project and process to the new team members. Review and provide inputs to MMP as well as Medical Monitoring, Displays or other data listing required to perform Medical review. The input should ensure unambiguous monitoring requirements as well as medical monitoring displays and data listing to enable efficient medical review. Qualifications A graduate degree in Medicine or a related field is required (MBBS & MD . MBBS & MD in other clinical areas with relevant experience in clinical patient management or clinical research will also be considered. Preferably above 3 years of relevant experience in Clinical Drug Development (Medical Data Review, Medical Monitoring, Investigator, Safety Surveillance, Scientific Clinical Drug Development etc). 1-2 years of project management experience is essential. Solid understanding of ICH (International Council for Harmonisation) guidelines and GCP (Good Clinical Practice) principles. Proficient in computer applications, including MS Office, MS Project, and PowerPoint. Strong grasp of medical terminology and clinical trial processes. Demonstrated analytical skills with a results-oriented approach. Exceptional proficiency in written and spoken English.

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 (Medical reviewers) and technical programmers (Functional programmers, statistical monitors). Medical reviewers are actively involved in Risk-based medical monitoring in collaboration with the medical specialists from Denmark, with a focus on ensuring overall patient safety and wellbeing of all clinical trial participants, by ensuring compliance to protocol and identifying potential clinically significant outliers that require medical attention and medical data cleaning. The Functional Programmers develop operational visualizations in data visualization tools to support the trial teams on proactive centralized monitoring and Statistical Monitors perform the detection of unusual data patterns, systematic errors, and potential lack of compliance or fraud across trials. The Position (NoteThis is not a role within Pharmacovigilance) The Medical Reviewer is responsible for conducting comprehensive medical reviews of clinical trial data across various therapy areas within the drug development portfolio. This role ensures the highest quality and consistency of medical data, with a strong emphasis on patient safety, protocol adherence, and compliance with Good Clinical Practice (GCP), ICH guidelines, local regulations, and Standard Operating Procedures (SOPs). Key responsibilities include collaborating closely with study team members—such as Data Managers, Trial Managers, and Medical Specialists—throughout the trial process, providing timely updates on the status of medical reviews, and escalating any issues to maintain trial integrity and compliance. Responsible for contribution to or participation in trial planning activities related to medical review. Perform the quality check measure for the medical review. Responsible for clarifying and if possible, resolving issues of medical concern and inconsistencies in clinical trial data with staff at investigational sites. Responsible for presenting findings of Medical Review to relevant Medical Specialists to enable decision-making. Responsible for documenting medical reviews in the sponsor TMF. Ensure close collaboration with relevant study group members, especially the Data Manager, Trial Manager(s), and Medical Specialist during trial conduct. Provide training on the project and process to the new team members. Review and provide inputs to MMP as well as Medical Monitoring, Displays or other data listing required to perform Medical review. The input should ensure unambiguous monitoring requirements as well as medical monitoring displays and data listing to enable efficient medical review. Qualifications A graduate degree in Medicine or a related field is required (MBBS & MD . MBBS & MD in other clinical areas with relevant experience in clinical patient management or clinical research will also be considered. Preferably above 3 years of relevant experience in Clinical Drug Development (Medical Data Review, Medical Monitoring, Investigator, Safety Surveillance, Scientific Clinical Drug Development etc). 1-2 years of project management experience is essential. Solid understanding of ICH (International Council for Harmonisation) guidelines and GCP (Good Clinical Practice) principles. Proficient in computer applications, including MS Office, MS Project, and PowerPoint. Strong grasp of medical terminology and clinical trial processes. Demonstrated analytical skills with a results-oriented approach. Exceptional proficiency in written and spoken English.

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 (Medical reviewers) and technical programmers (Functional programmers, statistical monitors). Medical reviewers are actively involved in Risk-based medical monitoring in collaboration with the medical specialists from Denmark, with a focus on ensuring overall patient safety and wellbeing of all clinical trial participants, by ensuring compliance to protocol and identifying potential clinically significant outliers that require medical attention and medical data cleaning. The Functional Programmers develop operational visualizations in data visualization tools to support the trial teams on proactive centralized monitoring and Statistical Monitors perform the detection of unusual data patterns, systematic errors, and potential lack of compliance or fraud across trials. The Position (NoteThis is not a role within Pharmacovigilance) The Associate Medical Reviewer is responsible for conducting comprehensive medical reviews of clinical trial data across various therapy areas within the drug development portfolio. This role ensures the highest quality and consistency of medical data, with a strong emphasis on patient safety, protocol adherence, and compliance with Good Clinical Practice (GCP), ICH guidelines, local regulations, and Standard Operating Procedures (SOPs). Key responsibilities include collaborating closely with study team members—such as Data Managers, Trial Managers, and Medical Specialists—throughout the trial process, providing timely updates on the status of medical reviews, and escalating any issues to maintain trial integrity and compliance. Responsible for contribution to or participation in trial planning activities related to medical review. Perform the quality check measure for the medical review. Responsible for clarifying and if possible, resolving issues of medical concern and inconsistencies in clinical trial data with staff at investigational sites. Responsible for presenting findings of Medical Review to relevant Medical Specialists to enable decision-making. Responsible for documenting medical reviews in the sponsor TMF. Ensure close collaboration with relevant study group members, especially the Data Manager, Trial Manager(s), and Medical Specialist during trial conduct. Provide training on the project and process to the new team members. Review and provide inputs to MMP as well as Medical Monitoring, Displays or other data listing required to perform Medical review. The input should ensure unambiguous monitoring requirements as well as medical monitoring displays and data listing to enable efficient medical review. Qualifications A graduate degree in Medicine is required.Candidates with an MBBS or MD in other clinical specialties, along with relevant experience in clinical patient management or clinical research, will be considered. Preferably above 1 years of relevant experience in Clinical Drug Development (Medical Data Review, Medical Monitoring, Investigator, Safety Surveillance, Scientific Clinical Drug Development etc). 1-2 years of project management experience is essential. Solid understanding of ICH (International Council for Harmonisation) guidelines and GCP (Good Clinical Practice) principles. Proficient in computer applications, including MS Office, MS Project, and PowerPoint. Strong grasp of medical terminology and clinical trial processes. Demonstrated analytical skills with a results-oriented approach. Exceptional proficiency in written and spoken English.

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.

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 activities. May serve as a back-up for a Lead Coder, DOC or DTL. Perform comprehensive quality control procedures, Assist in implementing new technology. Independently bring coding and project related solutions to the DM team. Handle audit requirements for respective studies including stand-alone coding projects as applicable. Understand and comply with core operating procedures and work instructions. Perform other duties as directed by the study team or Manager, or meet objectives as assigned Develop and maintain good communication and working relationship with the team. Qualifications Pharmacy, dental, medical, nursing, life sciences or related field qualification or educational equivalent 2 years of relevant experience or equivalent combination of education, training and experience. Excellent knowledge of medical terminologies, pharmacology, anatomy and physiology. In-depth knowledge of medical dictionaries used for coding (e.g., MedDRA, WHODD etc.). Understanding of the Data Management process from study start-up through to database lock. Ability to exercise excellent attention to detail and act independently with the initiative required to resolve problems. Good understanding of database technologies related to data management and coding. Knowledge of operating procedures and work instructions and the ability to apply them in practice. Excellent written and oral communication skills in English language, organizational and leadership skills. Ability to establish and maintain effective working relationships with co-workers, managers and clients. LPN - Licensed Practical Nurse - State Licensure Req

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 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 worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.You will be expected to develop and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for Adaptable and flexibleAbility to perform under pressureProblem-solving skillsDetail orientationAbility to establish strong client relationship Roles and Responsibilities: Data Review Report Programmers:Overall experience of 4+ years in Clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred.Participate in the lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support.Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders.Facilitate interaction with end user on creating specifications and working with programmers or performing the programming activities for successful delivery.Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred. Qualification BSc,Master of Pharmacy

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 system handling experience

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: Prepare and review clinical documents for regulatory submission, including but not limited to Protocols, Clinical Study Pharmacology Reports, Clinical Study Reports, Narratives, Post-Approval Documents, Clinical Summary of Safety, Clinical Summary of Efficacy, and Common Technical Document (CTD) Modules across various Therapeutic Areas. Quality Assurance: Conduct thorough quality checks of all clinical documents intended for regulatory submission, ensuring scientific content, organization, clarity, accuracy, format, and consistency meet high standards and regulatory guidelines. Regulatory Compliance: Ensure all prepared medical writing documents adhere to Standard Operating Procedures (SOPs), Document Standards, Guidance documents, regulatory guidelines, and applicable standards/styles. Team Coordination: Initiate start-up meetings with study teams, and work in close coordination with all internal and external study team members for the creation and development of clinical documents. Share project timelines with the study team. Data Review & Integration: Review statistical analysis plans and table/figure/listing, when required, ensuring uniformity and consistency in the scientific content of all regulatory documents. Project Management Support: Take an active role in assigned projects for planning content, format, and timing of documents, and report scheduling/tracking. Provide support to the clinical development or project team to meet project needs and department standards within established timelines. Peer Review & Quality Control: Perform peer review and quality control review of documents within established timelines, adhering to applicable guidelines and processes using appropriate checklists. Required Qualifications: Experience: Minimum 1 year of experience in eCTD / NEES / Docubridge . Demonstrated experience in making Clinical Study Reports and Clinical Summary of Safety . Education: Any Life Science Graduate. Skills: Strong writing skills, attention to detail, and a solid understanding of medical terminology and research practices. To Apply: WhatsApp Hi to +91 9151555419 . Then, follow these steps: Click on Start option to Apply and fill the details. Select the location as Other (to get multiple location options). a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 56 b) To Apply for above Job Role ( Pune ) Type : Job Code # 57 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 396

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 creation/refresh of a CS involves being able to review and interpret global regulatory guidance, to ensure the CS is adapted to evolving requirements. The team also engage with Business, Operations, Treasury, Legal, and Risk Management functions to gather their feedback and input. Your key responsibilities Support the completion of the annual data gathering outreach, including data validation / review. Analyze and interpret regulatory guidance and enhance existing contingency strategies to meet regulatory requirements. Independently manage the review/creation of multiple CSs for FMIs / Agent Banks ensuring a high and consistent standard of quality. Effectively manage communication, feedback and approval from internal senior stakeholders. Perform quality and consistency reviews of contingency strategies. Provide support for the Team lead / process oversight and governance. Your skills and experience Excellent reading and writing skills, with ability to independently draft new documentation suitable for regulatory submission. Strong ability to scrutinise extensive documentation, review and interpret regulatory guidance, to incorporate to the CS. Analytical and communications skills; effectively host meetings with multiple stakeholder groups including senior management/external audiences. Confident data review, analysis and presentation (pivots/v-lookup/text functions/formulas/SharePoint/PowerPoint/Excel) with high and consistent attention to detail. Ability to prioritise and effectively manage workload across multiple workstreams, working within tight time frames, providing accurate updates, escalations and highlighting remedial actions. Desirable to have; Understanding of Living Wills / Recovery and Resolution Planning and other applicable regulations. Understanding of the operations and functions of clearing houses, central securities depositories, and payment systems. Understanding of securities & cash products. Previous operational (settlement and clearing) industry experience Team or process lead/management experience

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 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 activities in a safe and efficient manner Performs other duties as assigned Qualifications Basic Minimum Qualifications: To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge, skill or ability required. Education/Experience: A masters degree in microbiology Additional Information Experience level :02 years of pharmaceutical experience preferred. Key Candidate Attributes: Self-motivation; excellent quality of work and attention to detail Ability to communicate effectively with coworkers and internal/external clients Ability to learn new tasks quickly and to move easily from task to task Ability to handle prioritization and multiple tasks simultaneously Ability to use a personal computer and learn necessary programs Good communication skills (oral and written) Organizational ability and good judgement Science background/education and/or laboratory experience