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1.0 - 5.0 years
0 - 0 Lacs
bangalore, karnataka, andhra pradesh
On-site
Key Responsibilities: Manage general medicine OPD and inpatient cases Conduct daily patient rounds and assist in treatment planning Ha ndle medical emergencies and coordinate with ICU teams Maintain accurate patient records and documentation Participate in academic and clinical discussions. Consultation with the patients and about his medical history. Examining the patient medical record histories. Fresher candidates preffered.
Posted 5 days ago
0.0 years
0 Lacs
hyderabad, telangana, india
Remote
Working with Us Challenging. Meaningful. Life-changing. Those aren&apost words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You&aposll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . Supports execution of assigned clinical trial activities and works closely with Clinical Scientist to execute activities associated with trial conduct Supports trial level activities for one or more trials with the necessary supervision Support development of Protocol and ICF documents / amendments Collaborate cross-functionally to monitor clinical data for specific trends Perform medical monitoring of assigned clinical studies Ensure CRF design CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming Conduct literature review. Support submission of clinical documents to TMF Support development of site and CRA training materials Review clinical narratives Seek out and enact best practices with instruction Provide regular and timely updates to manager/management as requested If you come across a role that intrigues you but doesn&apost perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol Responsibilities BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [HIDDEN TEXT] . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Show more Show less
Posted 6 days ago
5.0 - 9.0 years
0 Lacs
hyderabad, telangana
On-site
As a Medical Monitor, you will be responsible for overseeing the medical aspects of in-house clinical trials and managing the CRO's medical monitoring for outsourced projects. Your duties will include developing and reviewing various clinical documents such as protocols, investigator's brochures, case record forms, product rationales, prescribing information, and drug interactions. You will also be tasked with organizing materials for Subject Expert Committee (SEC) meetings and actively participating in these meetings to support clinical trials and marketing approvals. In addition to the primary responsibilities, you will be involved in the medical review of Individual Case Safety Reports (ICSRs), aggregate reports, signal reports, and Risk Management plans. You will also review clinical and non-clinical overviews and summaries of Common Technical Documents (CTD) and assess the medical rationale for Clinical Trial (CT) waiver applications. Furthermore, you will be expected to evaluate new products for development, as well as develop, review, and approve marketing requests related to product evaluations, comparative safety, and efficacy training materials. Additionally, you will play a key role in mentoring and training team members to enhance their skills and ensure timely project deliverables.,
Posted 1 week ago
5.0 - 8.0 years
4 - 8 Lacs
bengaluru
Work from Office
About The Role Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs Sr Analyst Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 5 to 8 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 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.A critical phase in clinical research that assures collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and analysis of studies across the spectrum of clinical research as defined by the National Institutes of Health (NIH). What are we looking for? Ability to establish strong client relationshipAbility to handle disputesAbility to manage multiple stakeholdersAbility to meet deadlinesAbility to work well in a teamRequire Clinical Data Managers with 5+ years experience along with CRA/CRC/Medical monitoring experience and hands on experience of clinical data management activities. Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Master of Pharmacy
Posted 2 weeks ago
5.0 - 9.0 years
0 Lacs
hyderabad, telangana
On-site
As a Clinical Data Services - Clinical Data Management professional at Accenture, you will be designated as a Clinical Data Svs Sr Analyst. With a Bachelor of Pharmacy or Master of Pharmacy qualification and 5 to 8 years of experience, you will play a crucial role in the Life Sciences R&D vertical. This vertical covers a wide range of services in the life sciences sector, including research laboratories, clinical trials support, regulatory services, pharmacovigilance, and patient services solutions. Your primary focus will be on Clinical Data Management, where you will be responsible for the collection, integration, and availability of data at appropriate quality and cost. This involves activities such as discrepancy review, query generation, resolution, creating CRF Completion Guidelines (CCG), SAE reconciliation guidelines, identifying protocol deviations, performing edit check validation, database validation, and managing clinical data management projects. Your role is critical in ensuring the integrity and accuracy of data in clinical research projects. To excel in this role, you must possess the following skills: - Ability to establish strong client relationships - Capability to handle disputes - Proficiency in managing multiple stakeholders - Strong time management skills to meet deadlines - Team player mindset to collaborate effectively We are seeking Clinical Data Managers with at least 5 years of experience, along with CRA/CRC/Medical monitoring experience and hands-on expertise in clinical data management activities. As a Sr Analyst, you will be tasked with analyzing and solving complex problems, collaborating with peers and clients, receiving minimal instructions for daily tasks, making decisions that impact your work and potentially others", and overseeing small work efforts or teams. Please note that this role may require you to work in rotational shifts. If you are passionate about leveraging technology and human ingenuity to drive innovation in the life sciences industry, we invite you to join us at Accenture. Visit www.accenture.com to explore more about our global professional services company and the exciting opportunities we offer.,
Posted 3 weeks ago
5.0 - 8.0 years
4 - 8 Lacs
hyderabad
Work from Office
Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs Sr Analyst Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 5 to 8 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 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.A critical phase in clinical research that assures collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and analysis of studies across the spectrum of clinical research as defined by the National Institutes of Health (NIH). What are we looking for? Ability to establish strong client relationshipAbility to handle disputesAbility to manage multiple stakeholdersAbility to meet deadlinesAbility to work well in a teamRequire Clinical Data Managers with 5+ years experience along with CRA/CRC/Medical monitoring experience and hands on experience of clinical data management activities. Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Master of Pharmacy
Posted 3 weeks ago
1.0 - 4.0 years
2 - 3 Lacs
mumbai
Work from Office
Responsibilities: Prepare clinical study reports, protocols & newsletters Design medical affairs strategies Conduct literature reviews & ICH compliance checks Write scientific documents with CRF & KOL input Protocols, abstracts, posters, manuscripts Provident fund
Posted 3 weeks ago
2.0 - 5.0 years
4 - 8 Lacs
Bengaluru
Work from Office
Novo Nordisk Global Business Services (GBS), India Department- Centralised Monitoring Unit (CMU)- Bangalore 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 Global Trial Portfolio area. It is a perfect blend of skilled medical professionals (Medical reviewers), technical programmers (Functional programmers, statistical monitors) and Medical Illustrators. Medical reviewers actively involved in Risk based medical monitoring in collaboration with the medical specialists from Denmark, with 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 requires medical attention and medical data cleaning. The Functional Programmers develop operational visualisations in data visualization tools to support the trial teams on proactive centralised monitoring and Statistical Monitors perform detection of unusual data patterns, systematic errors and potential lack of compliance or fraud across trials. Medical Illustrators are responsible for developing engaging visual content for our clinical meetings. The Position As Senior Central Monitor, an ideal candidate will be responsible for providing inputs in defining standard and trial specific key risk indicators and performing ongoing monitoring of operational risks. Ensure both standard and trial specific Key Risk Indicators (KRIs) impacting patient safety and data quality and regulatory compliance are appropriately defined as per protocol, monitoring strategy etc prior to start of centralised operational monitoring review. Responsible to Perform ongoing centralised operational monitoring activities on assigned studies using vendor platform dashboards/outputs in accordance with NN SOPs, ICH/GCP, regulatory guidelines & directives. Provide inputs to applications, databases and systems used to monitor operational data. Responsible for communication and findings of operational review to relevant stakeholders to enable decision making. Act as primary contact for relevant stakeholders and participate in project meetings for assigned centralized monitoring studies . Prior experience with RBQM (Risk-Based Quality Management) and field monitoring as a CRA is desirable. Familiarity with analytical tools is preferred, as well as experience using SAS, Python, R, and SQL. Contribute to discussions around share learnings and practices with wider CMU department colleagues and with other relevant stakeholders Maintain knowledge of and act in compliance with global and local SOPs, GCP and other regulatory requirements. Qualifications Minimum of bachelors degree in life science/scientific or health care discipline. Above 5 years of relevant clinical research experience with good knowledge of drug development process and risk-based quality management principles. Prior CRA/Field Monitoring and analytical tool experience is desirable Skill in aggregate data review and interpretation using visualization/analysis softwares Solid understanding of clinical trial design, trial execution and operations. Ability to successfully manage multiple projects and priorities. Good Communication & Presentation skills. Ability to work collaboratively and effectively in a cross functional and culturally diverse teams. Ability to work independently/responsively and with tight deadlines and under pressure. Quality mind-set and strong analytical skills, Strong attention to detail , Proactive and resilient to changes . Interact with colleagues, stakeholders, project members, management in a proactive and professional manner.
Posted 1 month ago
2.0 - 5.0 years
4 - 7 Lacs
Bengaluru
Work from Office
Novo Nordisk Global Business Services (GBS), India Department- Centralised Monitoring Unit (CMU)- Bangalore 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 Global Trial Portfolio area. It is a perfect blend of skilled medical professionals (Medical reviewers), technical programmers (Functional programmers, statistical monitors) and Medical Illustrators. Medical reviewers actively involved in Risk based medical monitoring in collaboration with the medical specialists from Denmark, with 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 requires medical attention and medical data cleaning. The Functional Programmers develop operational visualisations in data visualization tools to support the trial teams on proactive centralised monitoring and Statistical Monitors perform detection of unusual data patterns, systematic errors and potential lack of compliance or fraud across trials. Medical Illustrators are responsible for developing engaging visual content for our clinical meetings. The Position As Central Monitor, an ideal candidate will be responsible for providing inputs in defining standard and trial specific key risk indicators and performing ongoing monitoring of operational risks. Ensure both standard and trial specific Key Risk Indicators (KRIs) impacting patient safety and data quality and regulatory compliance are appropriately defined as per protocol, monitoring strategy etc prior to start of centralised operational monitoring review. Responsible to Perform ongoing centralised operational monitoring activities on assigned studies using vendor platform dashboards/outputs in accordance with NN SOPs, ICH/GCP, regulatory guidelines & directives. Provide inputs to applications, databases and systems used to monitor operational data. Responsible for communication and findings of operational review to relevant stakeholders to enable decision making. Act as primary contact for relevant stakeholders and participate in project meetings for assigned centralized monitoring studies . Prior experience with RBQM (Risk-Based Quality Management) and field monitoring as a CRA is desirable. Familiarity with analytical tools is preferred, as well as experience using SAS, Python, R, and SQL. Contribute to discussions around share learnings and practices with wider CMU department colleagues and with other relevant stakeholders Maintain knowledge of and act in compliance with global and local SOPs, GCP and other regulatory requirements. Qualifications Minimum of bachelors degree in life science/scientific or health care discipline. Above 3 years of relevant clinical research experience with good knowledge of drug development process and risk-based quality management principles. Prior CRA/Field Monitoring and analytical tool experience is desirable Skill in aggregate data review and interpretation using visualization/analysis softwares Solid understanding of clinical trial design, trial execution and operations. Ability to successfully manage multiple projects and priorities. Good Communication & Presentation skills. Ability to work collaboratively and effectively in a cross functional and culturally diverse teams. Ability to work independently/responsively and with tight deadlines and under pressure. Quality mind-set and strong analytical skills, Strong attention to detail , Proactive and resilient to changes . Interact with colleagues, stakeholders, project members, management in a proactive and professional manner.
Posted 1 month ago
1.0 - 5.0 years
0 Lacs
karnataka
On-site
The Associate Medical Reviewer position at Novo Nordisk Global Business Solutions (GBS) India, specifically in the Centralised Monitoring Unit (CMU) department in Bangalore, Karnataka, IN, offers a challenging and dynamic environment for individuals who are motivated by working closely with key stakeholders and strive for continuous improvement in their career objectives. As an Associate Medical Reviewer, you will play a crucial role in conducting comprehensive medical reviews of clinical trial data across various therapy areas within the drug development portfolio. Your responsibilities will include ensuring 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). You will collaborate 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. In this role, you will also be responsible for contributing to or participating in trial planning activities related to medical review, performing quality checks for medical reviews, clarifying and resolving issues of medical concern and inconsistencies in clinical trial data with staff at investigational sites, presenting findings of Medical Review to relevant Medical Specialists, documenting medical reviews in the sponsor TMF, and ensuring close collaboration with relevant study group members. To be successful in this role, you must hold a graduate degree in Medicine, preferably an MBBS or MD in other clinical specialties, along with relevant experience in clinical patient management or clinical research. Additionally, having 1-2 years of relevant experience in Clinical Drug Development, project management experience, a solid understanding of ICH guidelines and GCP principles, proficiency in computer applications, strong grasp of medical terminology and clinical trial processes, demonstrated analytical skills, and exceptional proficiency in written and spoken English are essential qualifications. Novo Nordisk is a leading global healthcare company with a strong legacy of driving change to defeat serious chronic diseases. By joining Novo Nordisk, you will have the opportunity to contribute to impacting millions of patient lives daily and be part of a team that is committed to making a difference in the world. If you are looking to be part of a collaborative and inclusive culture that celebrates diversity and values the unique skills and perspectives of its employees, then consider applying for the Associate Medical Reviewer position at Novo Nordisk GBS India. To apply for this position, please upload your CV online by the deadline of 29th July 2025. Novo Nordisk is committed to an inclusive recruitment process and equality of opportunity for all job applicants.,
Posted 2 months ago
2.0 - 7.0 years
0 - 0 Lacs
bangalore, bhubaneswar, cuttack
On-site
Registered Nurse Responsibilities: Maintaining accurate, complete health care records and reports. Administering medications to patients and monitoring them for side effects and reactions. Prescribing assistive medical devices and related treatments. Recording patient vital signs and medical information. Ordering medical diagnostic and clinical tests. Monitoring, reporting, and recording symptoms or changes in patient conditions. Administering non-intravenous medications. Assessing, implementing, planning, or evaluating patient nursing care plans by working with healthcare team members. Modifying patient health treatment plans as indicated by patient conditions and responses To apply submit your resume directly to, careers@bristolvitalityhospital.com
Posted 2 months ago
1.0 - 6.0 years
10 - 20 Lacs
Gandhinagar, Mumbai (All Areas)
Work from Office
*Greetings From You & I Consulting ! You & I Consulting has always been in the spotlight for getting placed in 64+ MNC's PAN India. *Hurry Do Not Miss This Opportunity To Work For Global Giant MNC. We are hiring for the below locations under Medical Reviewer Role!! *Open Locations :- * Gandhinagar / Mumbai *Mode Of Interview - Virtual *Mode Of Work :- Work From Office * CTC Upto - 10 To 24Lpa *Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app) or email your CV to puja@careersuni.com PFB Job Insights for Medical Reviewer Role!! Author a CCC for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database. Detail any requests for changes to the case, including the narrative. Skills required:- Computer Literate (good knowledge of MS Office) Sound understanding of the Drug Safety and Regulatory process Good problem solving and decision-making skills Capability to lead by motivation and example Ability to prioritize schedule and organize Excellent interpersonal and communication skills * * *Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app) email your CV to puja@careersuni.com ***Note we also have open positions for the below skills :- *Aggregate Reporting / Clinical Data Management / Clinical SAS / SQL Programmer / EDC Programmer / Medical Monitor / HEOR Health Economist Role / SAS + R / Statistical Programmer / Study Data Manager *Though We Try and Answer The Calls Immediately, but Due to Heavy Call Flow The Below Numbers Might Be Busy At Times. In case you find the number busy, please whatsapp your details to us in the below format: - Name- Mobile number - Mail - Qualification - Total work experience - Current Organization- Location - Last CTC Expected CTC:- *Interested candidates can even refer their friends or relatives provided the criteria *FOR interview Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app) email your CV to puja@careersuni.com
Posted 2 months ago
3.0 - 8.0 years
5 - 9 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 (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.
Posted 2 months ago
3.0 - 8.0 years
4 - 8 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 (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.
Posted 2 months ago
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 (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.
Posted 2 months ago
1.0 - 6.0 years
10 - 20 Lacs
Pune, Chennai, Mumbai (All Areas)
Work from Office
*Greetings From You & I Consulting ! You & I Consulting has always been in the spotlight for getting placed in 64+ MNC's PAN India. *Hurry Do Not Miss This Opportunity To Work For Global Giant MNC. We are hiring for the below locations under Medical Reviewer Role!! *Open Locations :- * Pune/ / Chennai / Mumbai *Mode Of Interview - Virtual *Mode Of Work :- Work From Office * CTC Upto - 10 To 24Lpa *Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app) or email your CV to puja@careersuni.com PFB Job Insights for Medical Reviewer Role!! Author a CCC for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database. Detail any requests for changes to the case, including the narrative. Skills required:- Computer Literate (good knowledge of MS Office) Sound understanding of the Drug Safety and Regulatory process Good problem solving and decision-making skills Capability to lead by motivation and example Ability to prioritize schedule and organize Excellent interpersonal and communication skills * * *Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app) email your CV to puja@careersuni.com ***Note we also have open positions for the below skills :- * * *Call Now our HR Specialist for more details:- @ puja - 8250242229 (call or whts app) email your CV to puja@careersuni.com *Aggregate Reporting / Clinical Data Management / Clinical SAS / SQL Programmer / EDC Programmer / Medical Monitor / HEOR Health Economist Role / SAS + R / Statistical Programmer / Study Data Manager *Though We Try and Answer The Calls Immediately, but Due to Heavy Call Flow The Below Numbers Might Be Busy At Times. In case you find the number busy, please whatsapp your details to us in the below format: - Name- Mobile number - Mail - Qualification - Total work experience - Current Organization- Location - Last CTC Expected CTC:- *Interested candidates can even refer their friends or relatives provided the criteria *FOR interview Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app) email your CV to puja@careersuni.com
Posted 3 months ago
1.0 - 6.0 years
1 - 6 Lacs
Kollam
Work from Office
Minimum 1 year experience in respective field Share the cv to recruitment@meditrinahospital.com 7736485552
Posted 3 months ago
2.0 - 6.0 years
10 - 14 Lacs
Hyderabad
Remote
Job description Remote & Full-time Opportunity for professionals with direct experience of min 2 years in disclosures. Job Description Summary The Clinical Trials Disclosure Specialist II position is responsible for the overall coordination and development of multiple disclosures deliverables, including but not limited to compliant registry authoring and maintenance of information on public registries, document redaction, and/or plain language authoring, ensuring adherence to relevant industry guidelines and client styles and formatting in accordance with all agreed upon timelines. Job Description Essential Functions: Independently performs/coordinates all activities for registration, maintenance, and results postings, including document redaction for clinical trials across global public registries (i.e., Clinicaltrials.gov, EudraCT, and other country-specific registries as applicable). Ensures development of high-quality registry, redaction, and plain language document deliverables that are compliant with all applicable policies, procedures, and regulations. Performs independent quality control review of registry and/or plain language document deliverables, ensuring accuracy against all relevant source documents. Works closely with internal Client team(s) to ensure understanding of applicable roles and responsibilities related to Clients disclosure obligations. Works with internal Client team(s) to ensure the source information is provided for disclosure activities in a timely manner. Maintains accurate and up-to-date records of individual study activities for timeline integrity, compliance, and relevant metrics tracking. Sets expectations where necessary and reports on project statuses to manager. Escalates issues to manager in a timely manner. Provides frequent and purposeful communication, ensuring all stakeholders are kept informed of progress and updates, as needed, in real time. Maintains constructive and positive interactions with colleagues. Develops strong, lasting relationships with client teams that encourage organic new business growth. Other duties as assigned. Necessary Skills and Abilities: Strong written and verbal communication skills. Self-motivated and able to work independently. Exceptional time management skills. Ability to drive projects with conflicting priorities in a matrix team environment, working with individuals from a variety of departments and in a range of countries. A proven team player who can focus on and drive goal completion. Ability to understand and apply international regulations and Client guidelines and requirements related to clinical trial transparency. Thinks proactively, takes initiative, and willingly takes on new challenges. Ability to identify areas of concern or inefficiency Works independently with good time management skills and contacts management team proactively when additional support and resources are needed. Works effectively in a collaborative team environment. Demonstrates a growth mindset and positive outlook in all work activities. Ability to understand and apply Client guidelines and requirements related to clinical trials disclosure and/or data transparency.
Posted 3 months ago
2 - 5 years
5 - 9 Lacs
Bengaluru
Work from Office
Department-Centralised Monitoring Unit (CMU) Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your career objectives? Then 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 in Pharmacology preferred; MBBS & MD in other clinical or paraclinical areas with relevant experience in clinical patient management or clinical research will also be considered). Preferably 3-5 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.
Posted 4 months ago
10 - 15 years
9 - 15 Lacs
Kolkata
Work from Office
Position Overview: We are seeking a highly experienced and visionary Medical Director to lead and oversee all medical and clinical initiatives within the organization. This role is pivotal in ensuring the medical and scientific integrity of our programs, providing strategic direction, and driving excellence across research, clinical operations, and stakeholder engagement. The ideal candidate will bring deep clinical expertise, strong leadership capabilities, and a passion for advancing healthcare outcomes through evidence-based practices and innovative solutions. Key Responsibilities: Provide strategic medical leadership across all research, clinical, and operational activities. Oversee the design, execution, and evaluation of clinical trials and research studies. Ensure compliance with all regulatory requirements, ethical standards, and Good Clinical Practice (GCP) guidelines. Serve as the primary medical representative in internal leadership discussions and external engagements with regulators, academic institutions, partners, and key opinion leaders (KOLs). Review, interpret, and communicate clinical and scientific data to support organizational goals and initiatives. Guide the development of medical content including clinical study protocols, scientific publications, regulatory documents, and strategic medical plans. Collaborate closely with cross-functional teams including R&D, Regulatory Affairs, Pharmacovigilance, and Commercial functions to align medical strategy with organizational objectives. Lead and mentor a multidisciplinary team of medical professionals and clinical staff. Support the development of risk management plans, safety monitoring, and adverse event reporting systems. Contribute to strategic planning and organizational growth from a medical perspective. Required Qualifications & Experience: MBBS/MD or equivalent medical degree (Postgraduate specialization in relevant field preferred) Minimum 1015 years of progressive experience in clinical research, medical affairs, or healthcare leadership roles Demonstrated experience in clinical development, regulatory affairs, and medical governance In-depth understanding of medical ethics, patient safety, and quality standards in clinical settings Proven track record of cross-functional leadership and stakeholder engagement Excellent analytical, communication, and decision-making skills Experience in interacting with regulatory authorities and health policy bodies is highly desirable
Posted 4 months ago
2 - 4 years
1 - 4 Lacs
Bengaluru
Work from Office
The Medical Monitor will serve as the primary medical expert responsible for the safety and scientific integrity of clinical trials. This role provides medical oversight to ensure patient safety, proper conduct of trials
Posted 4 months ago
8 - 12 years
12 - 22 Lacs
Pune, Bengaluru, Mumbai (All Areas)
Work from Office
Hi We are looking forward to hire Medical Monitor for our Client. Please go through the JD and Apply Responsibilities: Review protocol and provide suggestions Respond to queries/ clarifications from EC/ IRBs Answer medical questions from sites or project team Respond to queries from sites with regard to protocol Attend drug safety meetings/ external meetings Patient eligibility review Review AE/ SAEs Protocol training to site staff, CRAs etc Attend, participate/ present in investigator meetings Qualification: MBBS/ MD qualification Eligibility: 3 year+ of clinical trial experience Familiar with clinical trials operations Good English communication skills Proficiency in using Microsoft office To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 362 b) For Position in Pune Search : Job Code # 363 c) For Position in Bangalore Search : Job Code # 364
Posted 4 months ago
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