276 Clinical Data Jobs

The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process and determine the medical and scientific relevance of serious adverse event reports within the context of the product s safety profile as well as other products within the same therapeutic area. Also, this position plays a greater role as a senior technical leader and participate in matrix management activities including preparation or participation in evaluating safety issues and preparation of aggregate reports in collaboration with the Post-Marketing Safety Experts and Safety Surveillance Group and be responsible for surveillance activities for selected products. Essential Functions Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported Perform medical safety review of the protocol, Investigative Brochure, and/or Case Report Forms (CRFs) for appropriate safety content and data capture, as applicable Provide aggregate reviews of safety information, including but not limited to clinical data, postmarketing, literature review and observational studies to maintain oversight of a product s safety profile (e. g: DSUR, RMP, PBRER, ad hoc regulatory reports etc) Ensure service delivery from productivity, compliance and quality perspective within regulatory /contracted timelines. Lead and participate in the initiatives taken for the same from team delivery perspective Provide therapeutic area/pharmacovigilance issue guidance in the context of leading/managing other safety team members in single case assessment. Ensure update of watch list, list of expectednsess, labeling list/RSIs etc for the assigned products and develop such additional capabilities within the team Lead, drive and participate in training activities, product transitions, audit preparation and knowledge exchange initiatives Review and sign off on the Project Safety Plan and Medical Monitoring Plan per medical safety scope agreed in contract, as applicable Attend project meetings, medical safety team meetings, and represent safety and clinical data review findings during client meetings, as applicable Act as Lead Safety Physician, or additional team support, and/or back up on assigned projects as applicable Provide medical escalation support for medical information and EU Qualified Persons for Pharmacovigilance projects, as applicable 24 hour medical support as required on assigned projects Maintain awareness of medical safety-regulatory industry developments Provide support and participate in signal detection efforts, e. g. strategy meetings etc. as applicable Qualifications Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education. Req Three (3 years) experience practicing clinical medicine after award of medical degree. Graduate, and/or Residency training can qualify for clinical practice experience Req Two (2) years of pharma experience Pref Sound knowledge of Medicine In-depth knowledge of applicable global, regional and local clinical research regulatory requirements; i. e. , Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Knowledge of Pharmacovigilance- ICSR and Aggregate reports In-depth knowledge of departmental standard operating procedures (SOPs) Skill in use of multiple safety databases Adequate Computer skills, especially Microsoft word, excel & PowerPoint Good communication skills- verbal and written Ability to establish and maintain effective working relationships with managers, co-workers, investigative site staff, clients and regulatory agency representatives Ability to establish and maintain effective working relationships with coworkers, managers and clients A valid medical license, or equivalent, from the country or region in which he/she resides and works Pref IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs. iqvia. com

Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel their best. Here, you will find a culture guided by inclusion, talented peers, comprehensive benefits and career development opportunities. Come make an impact on the communities we serve as you help us advance health optimization on a global scale. Join us to start Caring. Connecting. Growing together. Primary Responsibility: As a FHIR Solutions Engineer, you will play a pivotal role in designing, developing, and implementing FHIR-based solutions. You will leverage your extensive experience and expertise in FHIR to enhance our clinical systems, ensuring seamless interoperability and data exchange. Day to day duties will include design and development of FHIR based clinical knowledge solutions, EMR integration, performing knowledge transfer, and participation in team agile process. Required Qualifications: Bachelor’s or master’s degree in computer science, Information Technology, or a related field 2+ years of experience in healthcare technology with a focus on FHIR based solutions 2+ years of Typescript/JavaScript experience 2+ years of experience in NPM/NodeJS 2+ years of experience in Bash Shell Scripting 2+ years of experience in GitHub/git 2+ years of intermediate level experience with Azure infrastructure and architecture 2+ years of experience in the healthcare industry 1.5+ years of FHIR Experience 1+ years of experience in GitHub Actions/Workflow 1.5+ years of experience in FHIR Specification and Operations Solid understanding of clinical data standards and interoperability Intermediate level proficiency with Terraform and cloud architecture Proven track record of successfully implementing FHIR-based solutions in large health care organizations Proven excellent problem-solving skills and attention to detail Proven solid communication and collaboration skills At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone–of every race, gender, sexuality, age, location and income–deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes — an enterprise priority reflected in our mission. #Nic ##NJP Apply Internal Employee Application

Job Overview Provide medical expertise on pharmacovigilance services to divisions as requested The Associate Medical Safety Director participates in all aspects of Medical Safetys involvement on assigned trials and stand alone safety projects with appropriate oversight from management or more senior medical safety directors, Essential Functions Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a products safety profile Provide coding review of AEs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data Represent safety and clinical data review findings during client meetings Provide medical review and edits to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports Provide medical review and edits of Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies Provide medical oversight for label development, review and change Provide medical support and attendance at Data Safety Monitoring Board Meetings Attends and contributes medical safety evaluation on Safety Monitoring Committees Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document Provide medical review and edits to Drug Safety Reports or other benefit-risk assessments Review and sign off on both the Project Safety Plan and the Medical Monitoring Plan per medical safety scope agreed in contract Perform Medical Safety review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs) for appropriate safety content and data capture, Act as Global Safety Physician or Assistant or Back-up on projects as assigned Attend project meetings, medical safety team meetings, and client meetings as requested Ensure coverage for all medical safety deliverables within regulatory or contracted timelines Provide medical escalation support for medical information projects Provide medical escalation support for EU Qualified Persons for Pharmacovigilance projects 24 hour medical support as required on assigned projects Maintain awareness of medical-safety-regulatory industry developments Qualifications Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education Req Three (3) years of clinical practice experience ( e-g graduate medical training) with two (2) additional years in the pharmaceutical or associated industry in any role Or equivalent combination of education, training and experience Req Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice Knowledge of clinical trials and pharmaceutical research process Ability to establish and meet priorities, deadlines, and objectives, Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility Ability to establish and maintain effective working relationships with coworkers, managers and clients A valid medical license, or equivalent, from the country or region in which he/she resides and works Pref IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide Learn more at https://jobs iqvia Show

The Scientific Communications Senior Manager is accountable for planning and delivering innovative scientific and medical content aligned to their designated Therapeutic Area / product (General Medicine, Inflammation, Oncology, Rare Disease, or Obesity), tailored to specific audiences globally via impactful formats and relevant channels. Reporting to a Scientific Communications Therapeutic Area (TA) Lead in India, this leader manages a small team of scientific communication team members and drives the execution of tactical Scientific Communication plans for US and global regions to deliver our Medical and overall product strategies. The Scientific Communications Senior Manager may directly partner with US/Regional Medical planning team and Scientific Communication Operations team members to drive process alignment, standardization, and adoption of innovation and transformational change. This role is responsible for creating and leading high-performing and engaged teams to exceed expectations. Roles and Responsibilities Develop and deliver high-quality, accurate, and innovative scientific and medical content (DSE/digital/MSL materials/FAQs/Medical Information Letters) tailored to specific audiences in the US and globally via impactful formats and relevant channels Publication-related deliverables (manuscripts / abstracts / posters / Oral presentations, enhanced content) Addressing Medical Information inquiries/issues Creation of payer-related content, timely support for compendia Maintain strong partnerships with Scientific Communication Operations team in support of standardization of processes, optimizing systems, and furthering continuous improvement and innovation, including use of digital and multi-channel approaches, as well as definition of impactful KPIs Drive the execution of a comprehensive scientific communication plan that shifts based on changes in the disease area and treatment landscape and in-depth awareness of insights across local affiliates and cross-functional partners Ensure compliance with relevant Amgen enterprise and Functional SOP(s) and system(s) Assist in recruiting, onboarding, and training of staff members Support prioritization process, prepare and oversee team assignments to meet program goals on time and within budget Develop, maintain, cultivate, and influence strong relationships with cross-functional colleagues Foster Amgen culture and motivate high-performing and empowered staff WHAT WE EXPECT OF YOU We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications Doctorate degree with a minimum of 10 years of experience in Global Publication, Medical Communications, Medical Value and Access, or Medical Strategy Master s degree with a minimum of 12 years of experience Bachelor s degree with a minimum of 14 years of experience Minimum of 5 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources Must-Have Skills MD, PharmD, PhD, or DO with 4 or more years of expertise in clinical research, patient care, Clinical Development, Medical/Scientific Affairs, and/or basic research (other doctorate degrees may be considered) Prior experience in Medical/Scientific Affairs or Clinical Development within the biopharmaceutical industry, and/or clinical or research in the therapeutic area An understanding of the pharmaceutical commercialization process and knowledge of the regulatory and legal guidelines affecting promotion of prescription products Experience in publication planning, publications guidelines and transparency standards (e. g. , ICMJE, current Good Publication Practice (GPP) Guidelines) Understanding of Amgen focused disease area and landscape and clinical data to enable critical analysis of scientific literature and communicate implications cross-functionally Demonstrated track record of strategic execution in a matrix environment with limited supervision The ability to work in teams and interface in a dynamic environment across corporate functions Preferred Skills Knowledge of emerging technologies in medical communications (e. g. , AI tools, omnichannel engagement platforms) Strong computer and database skills, particularly with Microsoft Office products Soft Skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Collaborative mindset with a strong sense of accountability and ownership Ability to drive continuous improvement and adapt quickly in a fast-evolving environment Strong project management with ability for self-direction

Career Category Medical Affairs Job Description Join Amgens Mission to Serve Patients If you feel like you re part of something bigger, it s because you are. At Amgen, our shared mission to serve patients drives all that we do. It is key to our becoming one of the world s leading biotechnology companies. We are global collaborators who achieve together, researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It s time for a career you can be proud of. WHAT YOU WILL DO The Scientific Communications Senior Manager is accountable for planning and delivering innovative scientific and medical content aligned to their designated Therapeutic Area / product (General Medicine, Inflammation, Oncology, Rare Disease, or Obesity), tailored to specific audiences globally via impactful formats and relevant channels. Reporting to a Scientific Communications Therapeutic Area (TA) Lead in India, this leader manages a small team of scientific communication team members and drives the execution of tactical Scientific Communication plans for US and global regions to deliver our Medical and overall product strategies. The Scientific Communications Senior Manager may directly partner with US/Regional Medical planning team and Scientific Communication Operations team members to drive process alignment, standardization, and adoption of innovation and transformational change. This role is responsible for creating and leading high-performing and engaged teams to exceed expectations. Roles and Responsibilities Develop and deliver high-quality, accurate, and innovative scientific and medical content (DSE/digital/MSL materials/FAQs/Medical Information Letters) tailored to specific audiences in the US and globally via impactful formats and relevant channels Publication-related deliverables (manuscripts / abstracts / posters / Oral presentations, enhanced content) Addressing Medical Information inquiries/issues Creation of payer-related content, timely support for compendia Maintain strong partnerships with Scientific Communication Operations team in support of standardization of processes, optimizing systems, and furthering continuous improvement and innovation, including use of digital and multi-channel approaches, as well as definition of impactful KPIs Drive the execution of a comprehensive scientific communication plan that shifts based on changes in the disease area and treatment landscape and in-depth awareness of insights across local affiliates and cross-functional partners Ensure compliance with relevant Amgen enterprise and Functional SOP(s) and system(s) Assist in recruiting, onboarding, and training of staff members Support prioritization process, prepare and oversee team assignments to meet program goals on time and within budget Develop, maintain, cultivate, and influence strong relationships with cross-functional colleagues Foster Amgen culture and motivate high-performing and empowered staff WHAT WE EXPECT OF YOU We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications Doctorate degree with a minimum of 10 years of experience in Global Publication, Medical Communications, Medical Value and Access, or Medical Strategy Master s degree with a minimum of 12 years of experience Bachelor s degree with a minimum of 14 years of experience Minimum of 5 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources Must-Have Skills MD, PharmD, PhD, or DO with 4 or more years of expertise in clinical research, patient care, Clinical Development, Medical/Scientific Affairs, and/or basic research (other doctorate degrees may be considered) Prior experience in Medical/Scientific Affairs or Clinical Development within the biopharmaceutical industry, and/or clinical or research in the therapeutic area An understanding of the pharmaceutical commercialization process and knowledge of the regulatory and legal guidelines affecting promotion of prescription products Experience in publication planning, publications guidelines and transparency standards (e. g. , ICMJE, current Good Publication Practice (GPP) Guidelines) Understanding of Amgen focused disease area and landscape and clinical data to enable critical analysis of scientific literature and communicate implications cross-functionally Demonstrated track record of strategic execution in a matrix environment with limited supervision The ability to work in teams and interface in a dynamic environment across corporate functions Preferred Skills Knowledge of emerging technologies in medical communications (e. g. , AI tools, omnichannel engagement platforms) Strong computer and database skills, particularly with Microsoft Office products Soft Skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Collaborative mindset with a strong sense of accountability and ownership Ability to drive continuous improvement and adapt quickly in a fast-evolving environment Strong project management with ability for self-direction WHAT YOU CAN EXPECT OF US As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. https://careers. amgen. com Amgen is an Equal Opportunity employer and will consider you without regard to your race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. .

Working with Us Challenging Meaningful Life-changing Those aren't 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'll 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 /working-with-us , Key Responsibilities Project Responsibilities: Provides comprehensive programming leadership and support to clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards Leads / Supports the electronic submission preparation and review Develops unambiguous and robust programming specifications ( e-g ADaM specifications) Reviews key planning documents ( e-g , statistical analysis plan, data presentation plan, data review plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements; Assesses document robustness and impact on programming activities Communicates proactively and effectively around issues and risks and contributes to its remediation Improvement Responsibilities Identifies, leads, and supports opportunities to enhance processes and technology Communicates proactively and effectively around issues and risks and contributes to its remediation Managerial Responsibilities (if applicable): Effectively recruits, manages, develops, evaluates, rewards, motivates, and retains up to 5 direct reports, resulting in an increasing level of capabilities within GBDS Conducts objective setting, performance check-ins, and year-end discussions in compliance with BMS policies; aligns objectives, feedback and performance evaluation with manager Meets regularly with direct reports, focusing on project updates, development needs, issue resolution, and provides real-time coaching and feedback; holds staff accountable for quality and timeliness of programming activities; ensures staff is compliant with training requirements Communicates with manager regarding promotions, performance concerns, and retention risks Builds and maintains a network with stakeholders and peers to ensure cross-functional strategies and objectives intertwine and build upon each other to achieve results Skills, knowledge, and experience Minimum Requirements Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required At least 8 years programming experience in industry including support of significant regulatory filings Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data Broad expertise in statistical programming and in developing computing strategies In-depth understanding of clinical data structure ( e-g CDISC standards) and relational databases Demonstrated proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools and applications ( e-g MS office, XML, Pinnacle 21) Demonstrated ability in processing of upstream data ( e-g multiple data forms, workflows, eDC, SDTM); Demonstrated ability in providing deliverables to meet downstream requirements, ( e-g ADaM, TFLs, e-submission components) Demonstrated ability to work in a team environment with clinical team members Preferred Requirements: Management experience supervising technical professionals If you come across a role that intrigues you but doesn't 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 adastaffingsupport@bms Visit careers bms / 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 /california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations, Show

Working with Us Challenging Meaningful Life-changing Those aren't 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'll 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 /working-with-us , Key Responsibilities Project Responsibilities: Provides comprehensive programming leadership and support to clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards Leads / Supports the electronic submission preparation and review Develops unambiguous and robust programming specifications ( e-g ADaM specifications) Reviews key planning documents ( e-g , statistical analysis plan, data presentation plan, data review plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements; Assesses document robustness and impact on programming activities Communicates proactively and effectively around issues and risks and contributes to its remediation Improvement Responsibilities Identifies, leads, and supports opportunities to enhance processes and technology Communicates proactively and effectively around issues and risks and contributes to its remediation Managerial Responsibilities (if applicable): Effectively recruits, manages, develops, evaluates, rewards, motivates, and retains up to 5 direct reports, resulting in an increasing level of capabilities within GBDS Conducts objective setting, performance check-ins, and year-end discussions in compliance with BMS policies; aligns objectives, feedback and performance evaluation with manager Meets regularly with direct reports, focusing on project updates, development needs, issue resolution, and provides real-time coaching and feedback; holds staff accountable for quality and timeliness of programming activities; ensures staff is compliant with training requirements Communicates with manager regarding promotions, performance concerns, and retention risks Builds and maintains a network with stakeholders and peers to ensure cross-functional strategies and objectives intertwine and build upon each other to achieve results Skills, knowledge, and experience Minimum Requirements Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required At least 8 years programming experience in industry including support of significant regulatory filings Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data Broad expertise in statistical programming and in developing computing strategies In-depth understanding of clinical data structure ( e-g CDISC standards) and relational databases Demonstrated proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools and applications ( e-g MS office, XML, Pinnacle 21) Demonstrated ability in processing of upstream data ( e-g multiple data forms, workflows, eDC, SDTM); Demonstrated ability in providing deliverables to meet downstream requirements, ( e-g ADaM, TFLs, e-submission components) Demonstrated ability to work in a team environment with clinical team members, Preferred Requirements: Management experience supervising technical professionals, If you come across a role that intrigues you but doesn't 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 adastaffingsupport@bms Visit careers bms / 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 /california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations, Show

Career Category Information Systems Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Senior Manager - Clinical Data Hub Team What you will do Let s do this. Let s change the world. In this vital role you will lead an Agile product squad and responsible for defining the vision & strategy and implementation for a range of Clinical Data products supporting Amgen Clinical Trial Design & Analytics. You will collaborate closely with statisticians, data scientists, data engineers, and AI/ ML engineers teams to understand business needs, identify system enhancements, and drive system implementation projects. Your extensive experience in business analysis, system design, and project management will enable you to deliver innovative and effective technology products. Roles & Responsibilities : Define and communicate the product feature vision, including both technical / architectural features and enablement, and end-user features, ensuring alignment with business objectives across multiple solution collaborator groups Create, prioritize, and maintain the feature backlog, ensuring that it reflects the needs of the business and collaborators Collaborate with collaborators to gather and document product requirements, user stories, and acceptance criteria Work closely with the business teams, Scrum Master and development team to plan and implement sprints, ensuring that the highest priority features are delivered Oversee the day-to-day management of technology platforms, ensuring that they meet performance, security, and availability requirements Ensure that platforms comply with security standards, regulatory requirements, and organizational policies Assure that AIN team is successfully creating robust written materials, including product documentation, product backlog and user stories, and creating other need artifacts to assure efficient and effective coordination across time zones. Oversee the resolution of service-related incidents and problems, ensuring minimal impact on business operations Maintains in-depth knowledge of clinical development business domains with an emphasis in data assets and data pipelines, as well as an understanding of the multi-functional dependencies. Analyze customer feedback and support data to identify pain points and opportunities for product improvement What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree / Masters degree / Bachelors degree and 12 to 17 years of experience in Computer Science, IT or related field of experience A solid foundation in modern software design and engineering practices and business analysis. Proven experience in undemanding and gather business requirements and delivered insight, and achieved concrete business outcome. Technical Proficiency: Good understanding of the following technologies: Python, R, AI/ML frameworks, relational databases/data modeling, AWS services ( EC2, S3, Lambda, ECS, IAM), Docker and CI/CD/Gitlab, Apache/Databricks, Expert understanding and experience of clinical development process within Life Sciences (global clinical trial data sources, SDTM & AdaM, end-to-end clinical data design and analysis pipeline, clinical data security and governance) Experience in Agile product development as a participating member of a scrum team and related ceremonies and processes Ability to collaborate with data scientists and data engineers to deliver functional business requirements as well defining product roadmap. High learning agility, demonstrated ability of quickly grasp ever changing technology and clinical development domain knowledge and applied to the project work. Strong communications skills in writing, speaking, presenting and time management skills. Preferred Qualifications: Training or education degree in Computer Science, Biology, or Chemistry. Experience with Clinical Data and CDISC (SDTM and ADaM) standard Soft Skills: Excellent analytical and troubleshooting skills Deep intellectual curiosity, particularly about data patterns, and learning about business processes and life of the user Highest degree of initiative and self-motivation Strong verbal and written communication skills, including presentation of varied audiences through complex technical/business topics Confidence in leading teams through prioritization and sequencing discussions, including managing collaborator expectations Ability to work effectively with global, virtual teams, specifically including leveraging of tools and artifacts to assure clear and efficient collaboration across time zones Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong problem solving, analytical skills; Ability to learn quickly and retain and synthesize complex information from diverse sources What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers. amgen. com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .

Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel their best. Here, you will find a culture guided by inclusion, talented peers, comprehensive benefits and career development opportunities. Come make an impact on the communities we serve as you help us advance health optimization on a global scale. Join us to start Caring. Connecting. Growing together. Primary Responsibility: As a FHIR Solutions Engineer, you will play a pivotal role in designing, developing, and implementing FHIR-based solutions. You will leverage your extensive experience and expertise in FHIR to enhance our clinical systems, ensuring seamless interoperability and data exchange. Day to day duties will include design and development of FHIR based clinical knowledge solutions, EMR integration, performing knowledge transfer, and participation in team agile process. Required Qualifications: Bachelors or masters degree in computer science, Information Technology, or a related field 2+ years of experience in healthcare technology with a focus on FHIR based solutions 2+ years of Typescript/JavaScript experience 2+ years of experience in NPM/NodeJS 2+ years of experience in Bash Shell Scripting 2+ years of experience in GitHub/git 2+ years of intermediate level experience with Azure infrastructure and architecture 2+ years of experience in the healthcare industry 1.5+ years of FHIR Experience 1+ years of experience in GitHub Actions/Workflow 1.5+ years of experience in FHIR Specification and Operations Solid understanding of clinical data standards and interoperability Intermediate level proficiency with Terraform and cloud architecture Proven track record of successfully implementing FHIR-based solutions in large health care organizations Proven excellent problem-solving skills and attention to detail Proven solid communication and collaboration skillsAt UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyoneof every race, gender, sexuality, age, location and incomedeserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes an enterprise priority reflected in our mission. #Nic ##NJP

A Multicentre multi-method study for development and Validation of a Deprescribing Tool, followed by Implementation and evaluation of its impact, facilitators and barriers. Consultant- Data Manager Preferred Qualifications: 1. Three years Graduate in relevant subject / field + three years experience or PG in relevant subject / field 2. For Engineering / IT /CS first class four years Graduate Degree + Three years Experience Language : Good communication in English and local languages Experience: Two to three years experience in a recognized institute/hospital Knowledge of Computer Applications Experience in prescription data collection/analysis or research project Experience in Clinical data collection, including interviews/surveys Last Day for Receiving Application: 30th July 2025 Roles and Responsibilities: Manage data entry, Ensure data accuracy and security, follow up with sites, and query correction.

About The Role Skill required: Clinical Data Operations - Clinical Database Testing Designation: Clinical Data Svs Specialist Qualifications: Master Degree in Life Sciences 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 world s leading biopharma companies bring their vision to life and enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Testing Team is dedicated to conduct through validation of all clinical trial database components ensuring that database meets quality standards while remaining cost effective. Their responsibilities include reviewing requirement specification, developing test scripts for carious testing types, performing data entry according to these scripts, executing test steps, documenting results and maintaining comprehensive records of all tested components in compliance with regulatory requirements.Design and test EDC databases, create and maintain User Acceptance Testing (UAT) procedures for EDC systems, including the creation of test plans, verification of requirements for databases, eCRFs, edit checks, extractions, and reports. What are we looking for Adaptable and flexibleAbility to perform under pressureProblem-solving skillsAbility to establish strong client relationshipAgility for quick learningExperience with Clinical testing - Creation of test scripts for all types of UAT including eCRF UAT, Edit checks UAT, Clinical Data Model UAT and Reports listing UAT and execution of test steps Followed with strong documentation skills and Knowledge of regulatory guidelines such as GCP, ICH, 21 CRF Part 11 and GDRP. Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualification Master Degree in Life Sciences

About The Role Skill required: Clinical Data Operations - Clinical Database Testing Designation: Clinical Data Svs Sr Analyst Qualifications: Master Degree in Life Sciences Years of Experience: 5 to 8 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 world s leading biopharma companies bring their vision to life and enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Testing Team is dedicated to conduct through validation of all clinical trial database components ensuring that database meets quality standards while remaining cost effective. Their responsibilities include reviewing requirement specification, developing test scripts for carious testing types, performing data entry according to these scripts, executing test steps, documenting results and maintaining comprehensive records of all tested components in compliance with regulatory requirements.Design and test EDC databases, create and maintain User Acceptance Testing (UAT) procedures for EDC systems, including the creation of test plans, verification of requirements for databases, eCRFs, edit checks, extractions, and reports. What are we looking for Adaptable and flexibleAbility to perform under pressureProblem-solving skillsAbility to establish strong client relationshipAgility for quick learningExperience with Clinical testing - Creation of test scripts for all types of UAT including eCRF UAT, Edit checks UAT, Clinical Data Model UAT and Reports listing UAT and execution of test steps Followed with strong documentation skills and Knowledge of regulatory guidelines such as GCP, ICH, 21 CRF Part 11 and GDRP. 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 Master Degree in Life Sciences

About The Role Skill required: Clinical Data Operations - Clinical Database Testing Designation: Clinical Data Svs Analyst Qualifications: Master Degree in Life Sciences Years of Experience: 3 to 5 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 world s leading biopharma companies bring their vision to life and enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Testing Team is dedicated to conduct through validation of all clinical trial database components ensuring that database meets quality standards while remaining cost effective. Their responsibilities include reviewing requirement specification, developing test scripts for carious testing types, performing data entry according to these scripts, executing test steps, documenting results and maintaining comprehensive records of all tested components in compliance with regulatory requirements.Design and test EDC databases, create and maintain User Acceptance Testing (UAT) procedures for EDC systems, including the creation of test plans, verification of requirements for databases, eCRFs, edit checks, extractions, and reports. What are we looking for Adaptable and flexibleAbility to perform under pressureProblem-solving skillsAbility to establish strong client relationshipAgility for quick learningExperience with Clinical testing - Creation of test scripts for all types of UAT including eCRF UAT, Edit checks UAT, Clinical Data Model UAT and Reports listing UAT and execution of test steps Followed with strong documentation skills and Knowledge of regulatory guidelines such as GCP, ICH, 21 CRF Part 11 and GDRP. Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualification Master Degree in Life Sciences

About The Role Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Specialist Qualifications: BE 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.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 SDTM ProgrammingStatistical ProgrammingPython (Programming Language)Ability to establish strong client relationshipAbility to handle disputesAbility to manage multiple stakeholdersClinical EDC Design Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualification BE

About The Role Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical data SVS Analyst Qualifications: Any Graduation,BE,MCA Years of Experience: 3-5 Yrs 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.In this role, you will be expected to develop clinical trial reports using SAS/ J-review / Congnos / SQL / PLSQL as per the study requirement What are we looking for Clinical Database ProgrammingClinical Data ManagementOracle Procedural Language Extensions to SQL (PLSQL)Adaptable and flexibleAbility to perform under pressureProblem-solving skillsAgility for quick learningAbility to work well in a teamSAS ClinicalStructured Query Language (SQL 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 Any Graduation,BE,MCA

Job Title Modality Sales Specialist - Enterprise Informatics (Medical Devices) Job Description In this role you provide technical expertise through sales presentations, product/solutions demonstrations, installation and maintenance of company products, solutions and services. Drives overall business and product deal support by providing clinical and technical product (modality) expertise on the product / modality across the accounts. Your role: Lead cross-functional healthcare initiatives using advanced modality expertise. Analyze clinical data to identify diagnostic or therapeutic opportunities. Develop innovative, evidence-based solutions for complex technical challenges. Oversee implementation of new procedures and protocols across departments. Provide consultative guidance within and beyond modality specialization. Evaluate feasibility and compliance of emerging healthcare technologies. Drive process improvements to enhance patient outcomes and operational efficiency. Collaborate across disciplines to support organizational goals and innovation. Maintain expertise in modality trends, contributing to training and strategic planning. Youre the right fit if you have: Master s or bachelor s degree with at least 8+ years of overall work experience. 5+ years experience in Healthcare Informatics - imaging, informatics, and clinical applications Technical Product Expertise Deep understanding of informatics, cardiology, radiology, and clinical applications Ability to craft and deliver impactful, value-driven presentations across healthcare modalities Excellent stakeholder connect How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company s facilities. Field roles are most effectively done outside of the company s main facilities, generally at the customers or suppliers locations. This is a mobile role which requires travel. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we wont stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. Learn more about our business . Discover our rich and exciting history . Learn more about our purpose . If you re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here . #LI-PHILIN

Position Title: CQA Document Control Associate Department: Clinical Quality Assurance Ora Values the Daily Practice of Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor At Ora, we are building the future of ophthalmic clinical research. As the world s leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market. Over the past 45 years, our expert teams have helped earn more than 85 new product approvals. Oras pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects. Today, our team continues to expand across the globe, with over 600 employees across North America, Europe, Asia, and Latin America. The Role: Our global Clinical Quality Assurance (CQA) Document Control Associate will support our Quality Management team to ensure accuracy and efficiency throughout every aspect of the Quality Document Control system. This position provides support to the CQA Document Control Specialist and is responsible for maintaining electronic training files and tracking compliance across the company, in accordance with guidelines and regulations. This position requires a strong organizational background to assist in maintaining Ora s EMS and providing companywide support for training tracking, assignment, and reporting. In this role, you will be trained on preparing, updating/revising, and maintaining all Quality Management System Documents (procedures, policies, work instructions, forms, templates, and manuals) in addition to maintaining tracking reports to present metrics for Key Performance Indicators to report to Ora s Senior Management team. What You ll Do: Ensure, with supervision, proper maintenance of clinical documentation databases and systems Assist with running reports and tracking status of Quality Assurance metrics Assist with change management for Quality document revisions Assist with editing documents needed for the QMS Upload, assign, and track training within Ora s Electronic Management System (EMS) Review external distribution requests, obtain approvals, and distribute documents utilizing Ora s approved document sharing platform Assist CQA Document Control Specialist with managing EMS user accounts, training records, system access issues, uploading QMS and study-specific documents Maintain adequate records of all Quality and operational documents Travel requirements less than 10% domestically Adhere to all aspects of Ora s quality system. Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora s data integrity & business ethics and regulatory requirements. Clear and sustained demonstration of Ora s values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor as well as their linked behaviors. Responsibilities may differ from the above based on the specific needs of the business. What We Look For: Experience needed for the Role: Bachelor s degree in Life Sciences or a minimum of 1 year experience in Quality-related field. Years of experience may be considered in lieu of education. Experience working with document management or training systems Proficiency in Microsoft Word, Excel, and Outlook Additional Skills and Attributes: Familiarity with the clinical trial process and clinical Quality Assurance Experience in other areas of GCP/GLP/GMP Quality Assurance Excellent English business communication skills with the ability to collaborate, document clearly, and communicate professionally across teams Ability to work well in a team environment and follow procedures Strong commitment to the accomplishment of tasks Ability to work in a fast-paced environment Exceptional attention to detail with emphasis on accuracy and quality Excellent verbal and written communication skills Excellent organization and time management skills Strong interpersonal and customer service skills Competencies and Personal Traits: What We Do: Execution Excellence: Ability to set goals, create structure, and maintain a focused and collaborative approach to the delivery of timely and high-quality work How We Do It: IQ, EQ, and SQ: Agile and positive thinker, communicator, and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience, and empathy. Scientific, intellectual, and emotional/social curiosity creates the willingness and ability to innovate, make mistakes, learn, and try again. Clear and Direct Communication, Feedback and Conflict Resolution: Practice radical candor in your communication and participate in active listening. Giving and receiving feedback frequently with an open heart and mind creates psychological safety and promotes faster individual, team, and company growth. Why We Do It: Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world. At Ora, we are creating vision beyond what we see. Our mission is to weave together people, processes, and technology to support innovation in ophthalmology around the world. We believe our business should be a force for good to improve, heal, and change how we see. As a global company, our vibrant community and culture are nurtured by our core values: Prioritizing kindness, cultivating joy, operational excellence, and scientific rigor. Through our commitment to these values, we have built an inclusive and supportive work environment that fosters respect, accountability, and a fulfilling work-life balance for every team member. We know a diverse workforce adds to our collective value and strength as an organization. People of color, the LGBTQIA+ community, disabled candidates and veterans are strongly encouraged to apply. Ora is proud to be an Affirmative Action and Equal Opportunity Employer, committed to equal employment opportunity and fair, equitable compensation regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Our Privacy Policy | Ora (oraclinical.com)

Roles and Responsibility Define project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design and Data Review and Data Reconciliation tools. Understand external data collection, its integration into the clinical trial, and the management and reconciliation processes required to ensure its accuracy and relevance. Execute data cleaning strategies to accelerate the time to achieve subject data cleanliness and ensure high-quality, timely deliverables. Perform holistic data review and trending analysis via reporting and elluminate analytics to proactively identify issue, risks and develop mitigation strategies. Utilize artificial intelligence (AI) and machine learning (ML) for anomaly and outlier detection to enhance the efficiency and quality of trial data. Monitor and interpret key performance indicators (KPIs), metrics, dashboards, Clinical Trial Operational Analytics (CTOA), and reports to provide actionable recommendations to study lead(s)/project manager. Perform Query Management Define specifications and collaborate with technical team on configuration of centralized data management platform, elluminate Data Central for data cleaning strategy and oversight activities. Prepare and maintain data management documentation (e.g., DMP, CCGs, Help Text, DVS) and update throughout trial lifecycle. Review and ensure the quality control of team-developed deliverables, covering eCRFs, study documents, program/report specifications, outputs, and elluminate Data Central with analytics modules. Actively evaluate and contribute to enhance processes to increase efficiency and effectiveness. Collaborate and work as a team to ensure the deliverables are completed on time with high quality. Ensure compliance with eClinical Solutions/industry quality standards, regulations, guidelines, and procedures. Other duties as assigned.

Premier Research is looking for a Senior Database Developer - Bangalore based to join our Clinical Data Sciences team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. We are Built by You. Your ideas influence the way we work, and your voice matters here. We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Together, we are Built for Biotech . Join us and build your future here. What youll be doing: Produces database documentation including an annotated CRF Creates electronic Case Report Forms (eCRFs) according to finalized protocols for EDC studies and assist with paper based CRFs as necessary Creates data entry screens according to the approved annotated Case Report Form (CRF) for paper studies Designs, builds and tests databases according to Premier Research standard operating procedures in operation at that time Programs field derivations, edit checks, and setup of screen flow in the CDMS for Data Entry This role requires you to be 2 days in the Bangalore office each week. What were looking for: Bachelor s degree level, or equivalent. In lieu of this qualification, 3 years of experience in clinical research, drug development or healthcare environment will be required Minimum of 3 years clinical database development experience. Alternatively, must have proven experience in all primary job functions - strong Custom Functions or BO4.2 (reports/data visualization) programming skills Expertise in ICH/GCP and/or ISO14155 requirements Works with internal and external customers/vendors to meet project specific goals.

You have an exciting opportunity to join Anervea.AI as a Clinical Data Scientist in their Pune office. Anervea.AI is seeking individuals with expertise in Clinical Data, Python, GenAI, RAG Framework, LLM, HealthTech, biomedical, and Pharmaceutical domains. As a part of the team, you will be responsible for developing, training, and fine-tuning large language models and generative architectures such as LLMs, VAEs, Transformers, and GANs. You will also integrate models with applications using frameworks like LangChain, LlamaIndex, and RAG, design LLM-based agents for various use cases, and build prompt templates and semantic memory flows using vector databases like Pinecone or FAISS. In this role, you will collaborate closely with backend and data teams to ingest data from a variety of sources including PDFs, APIs, structured databases, and JSON files. It will be your responsibility to benchmark model outputs, run experiments to optimize cost, performance, and quality, and stay updated on the latest AI research to implement useful techniques in production environments. Additionally, you will be expected to write clear, modular, reusable code with proper documentation and test coverage, as well as troubleshoot any model-related deployment or inference issues that may arise. To excel in this position, you must possess strong Python programming skills and have experience with foundation models like Transformers, Hugging Face, OpenAI/Anthropic APIs, and Med-GEMMA. Familiarity with agentic frameworks such as LangChain, LlamaIndex, LangGraph, and semantic RAG, along with experience in working with vector databases like Pinecone, FAISS, or Weaviate is essential. You should also be comfortable with prompt engineering, few-shot learning, fine-tuning basics, and have the ability to process and clean unstructured data like PDFs, notes, and research papers. Understanding of NLP metrics, model evaluation techniques, and bonus experience with biomedical or clinical data will be advantageous. Moreover, familiarity with deploying models via FastAPI, Docker, or Streamlit will be considered a bonus. As a candidate, you are expected to possess certain personal attributes including curiosity, attention to detail, ownership mindset, ability to work independently, passion for building usable AI, and strong communication and collaboration skills. Bonus qualities that will set you apart include having built or deployed LLMs into production, experience with healthcare or life sciences data, and showcasing personal projects, GitHub repos, or AI experiments that reflect your passion for the field. The interview process for this opportunity will involve a technical round with the Head of Engineering at Anervea.AI. To apply for this position, you can follow the simple steps provided - Click on Apply, Register or Login on the portal, complete the Screening Form, and upload your updated resume to increase your chances of getting shortlisted for an interview with the client. At Uplers, our aim is to make hiring reliable, simple, and fast for all our talents. We are here to support you throughout your engagement and help you progress in your career. If you are ready for a new challenge, a great work environment, and an opportunity to elevate your career to the next level, apply today and take the first step towards joining our team at Anervea.AI. We are excited to welcome you on board!,

As a Clinical Microbiologist & Infection Control Officer at HaystackAnalytics, a HealthTech company based in Navi Mumbai, you will be an integral part of our Medical Affairs team. Your role will involve collaborating closely with the Medical Affairs Head to support reporting, documentation, and data analysis for clinical and scientific projects. You will have the opportunity to contribute to the interpretation and presentation of clinical data, coordinate internal communications within the team, and participate in various medical discussions and training sessions. Your responsibilities will include drafting, reviewing, and organizing scientific and clinical reports, maintaining confidentiality and accuracy in handling medical documents and sensitive clinical data, and staying updated on developments in microbiology and infectious disease diagnostics. Additionally, you will be expected to understand the microbiological and clinical aspects of our products and effectively communicate this information in a professional manner. Sharing relevant case studies, clinical experiences, or infection trends to highlight product effectiveness will be a key aspect of your role. We are looking for a Fresher with an MD specialization in Microbiology (Completed) and a strong academic background in infectious diseases, clinical microbiology, and diagnostics. Excellent documentation and communication skills are essential, along with a proactive attitude, high attention to detail, and willingness to travel and participate in in-person meetings as required. Proficiency in Microsoft Office tools and scientific writing is preferred, along with a demonstrated understanding of infection control protocols, antimicrobial stewardship principles, and molecular technologies such as Next-Generation Sequencing (NGS). In this role, you will gain valuable experience in supporting cutting-edge medical research and genomic diagnostics, work with a highly accomplished Medical Affairs team, and have exposure to real-world clinical documentation and healthcare innovation. You will have opportunities for professional growth and learning in a mission-driven healthcare environment, particularly in the field of advanced sequencing technology in the diagnostic industry. Additionally, we offer a competitive salary commensurate with experience and a comprehensive health benefits package. If you are passionate about microbiology, infectious diseases, and diagnostics, and eager to contribute to a dynamic and collaborative team environment, we encourage you to apply for this position and be part of our innovative journey at HaystackAnalytics.,

Responsibilities : - Conduct comprehensive toxicology risk assessments across diverse scenarios, ensuring robust safety evaluations. Conduct & review of toxicology risk assessments for excipients, impurities, solvents, extractables and leachables, ensuring adherence to regulatory standards. Execute Environmental Risk Assessments (ERA) in compliance with the latest EMA guidelines. Prepare, maintain, and update toxicology summaries for globally marketed products in alignment with company policies. Develop and compile PDE and OEL monographs to support safety evaluations. Prepare clinical and non-clinical dossier modules (Modules 2.4, 2.5, 2.6, 2.7, 4, and 5) for regulatory submissions. Manage preclinical studies and associated documentation to ensure compliance and accuracy. Perform QSAR genotoxicity assessments in accordance with ICH M7 guidelines. Utilize advanced in-silico predictions (DEREK, SARAH, NEXUS, TOXTREE, OECD Toolbox) for data analysis and risk assessment. Provide expert guidance in addressing client and regulatory inquiries effectively. Background Required - Qualified Toxicologist Signing non-clinical/ toxicological reports/ modules/ expert reports Drafting of Environmental risk assessment reports Due diligence of pre-clinical data and drafting strategy for non-clinical studies for complex generics, NCEs, Biologics etc Drafting and review of non-clinical CTD modules Drafting of PDE reports Toxicological risk assessment of impurities/ leachables/ extractables Required education: Qualified and experienced Toxicologist Required experience : At least 2 years of experience in above mentioned activities.

Summary Step into a pivotal role where your expertise will shape the future of clinical data science platforms. As a Snr. Specialist in IT Solution Delivery, you ll be at the heart of configuring and customizing the SCAPE Statistical Compute Environment (SCE), driving innovation and precision in clinical trials. Collaborating across global teams, you ll deliver scalable, compliant solutions that empower data-driven decisions and accelerate breakthroughs in healthcare. About the Role Key Responsibilities -Configure, customize, and integrate SCAPE SCE components iteratively to meet business needs Design and deliver SCE solutions aligned with architectural standards and operational requirements Own delivery of specific SCE components and use cases from concept to execution Ensure solution designs support development, execution, and operations of the SCE platform Facilitate peer reviews and secure business sign-off on detailed designs Uphold security and compliance standards across all service delivery activities Collaborate across SCAPE workstreams to ensure timely and budget-conscious delivery Essential Requirements Bachelor s degree in Computer Science , Engineering, or a related technical field, or equivalent experience Minimum 5 years experience in IT, with a focus on biostatistics and quantitative science platforms in pharma Proven ability to collaborate across global, cross-functional teams and organizational boundaries Strong knowledge of Agile, Lean Six Sigma, and Design Thinking methodologies Hands-on experience with cloud-based data science platforms and open-source technologies (e.g., R, Python, Docker) Demonstrated success delivering validated IT solutions at scale in regulated environments Desirable Requirements Experience with Domino platform for data science workflows Familiarity with EasyBuild tools and AI/ML integration in cloud environments Benefits & Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally: Novartis Life Handbook Benefits in Spain include Company Pension plan; Life and Accidental Insurance; Meals; Allowance or Canteen in the office; Flexible working hours. You ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. Benefits in Spain include Company Pension plan; Life and Accidental Insurance; Meals; Allowance or Canteen in the office; Flexible working hours Commitment to Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. This role is based in Barcelona, Spain. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

JOB Description: Testing Engineer About Us: Inductive Quotient was founded by statisticians and technology industry experts with over 20 years of experience Inductive quotient aims to transform businesses and processes with its advanced digitization capabilities. With advanced AI and Machine Learning techniques we are helping Life Sciences industry to create a better healthcare system, and our Data Science capabilities helps organizations to create breakthrough solutions to transform businesses and drive sales growth. Website: www.inductivequotient.com We are seeking a skilled EDC Tester to validate the functionality, usability, compliance, and performance of our clinical EDC platform. You will be responsible for writing and executing test cases for study setup, subject visit flows, dynamic form logic (validations, derivations), and data integrity across various stages of the clinical trial lifecycle. Key Responsibilities Analyse EDC system specifications and design comprehensive test plans. Test core modules: Study Setup, Subject Management, Visit Schedules, Form Configuration, Dynamic Validations, Query Management, and SDV tracking. Perform UI, functional, regression, and integration testing. Log and track defects using tools like JIRA or TestRail. Collaborate with the QA lead, product managers, and developers to ensure test coverage. Mandatory Requirements Proven experience testing EDC systems (e.g., Medidata Rave, OpenClinica, Veeva Vault EDC, etc.) Strong understanding of clinical data workflows and study lifecycle Familiarity with CDISC/CDASH standards Experience testing form derivations, validations, skip logic , and audit trails Experience with API testing using Postman or similar tools Knowledge of 21 CFR Part 11 compliance and audit-ready systems. Good to Have Hands-on with automation testing frameworks Understanding of dynamic forms and clinical metadata models Background in clinical research or health informatics Experience : Experience (around 5years) Why Inductive Quotient? We are team a of 75+ talented and passionate professionals with strong statistical and analytical background combined with required study expertise. We IQians take lots of pride in our culture that enables open and creative thinking, deeply valuing our employees and their contributions towards our organization success.

Education - MD specialisation in Microbiology. Job Summary We are seeking a dedicated MD in Microbiology to join our Medical Affairs team. The role involves close collaboration with the Medical Affairs Head to support reporting, documentation, and data analysis related to clinical and scientific projects. The position is based in Navi Mumbai, with potential travel and meeting participation as part of the job. What We Want You To Do Assist the Medical Affairs Head in drafting, reviewing, and organizing scientific and clinical reports. Analyze clinical data and contribute to interpretation and presentation of findings. Coordinate internal communications and documentation flow within the Medical Affairs team. Attend and support internal and external meetings, medical discussions, and training. Liaise with cross-functional teams including Sales, and Operations. Maintain confidentiality and accuracy in handling medical documents and sensitive clinical data. Stay updated on developments in microbiology and infectious disease diagnostics. Understand the microbiological and clinical aspects of our products in a clear and professional manner. Share relevant case studies, clinical experiences, or infection trends to highlight product effectiveness. Maintain a strong understanding of emerging microbiological trends and technologies, including Next-Generation Sequencing (NGS). Optionally participate in Continuing Medical Education (CME) programs and Round Table Meetings (RTMs) What Are We Looking In You Fresher - MD in Microbiology (Completed). No other educational qualifications will be considered. Strong academic foundation in infectious diseases, clinical microbiology, and diagnostics. Excellent documentation and communication skills. Eagerness to work in a collaborative environment with dynamic responsibilities. Willingness to travel and participate in in-person meetings as required. High attention to detail, time management, and a proactive attitude. Proficient in Microsoft Office tools and scientific writing (preferred). Demonstrated understanding of infection control protocols and antimicrobial stewardship principles. Familiarity with molecular and sequencing (NGS) technologies and their applications in clinical microbiology is advantageous. Open to travel to PAN India for CME programs and RTMs. What You Will Gain Experience in supporting cutting-edge medical research and genomic diagnostics. Opportunity to work with a highly accomplished Medical Affairs team. Exposure to real-world clinical documentation and healthcare innovation. Professional growth and learning opportunities in a mission-driven healthcare environment. Experience in working with advanced sequencing technology in the diagnostic industry i.e. NGS, WGS, Nanopore, and Illumina. Competitive salary commensurate with experience Comprehensive health benefits package