276 Clinical Data Jobs - Page 8

EkaCare (Orbi Health) is a well-funded startup working on a suite of technologies in the healthcare domain ranging from AI-powered EMR for doctors to one of the most comprehensive personal health record (PHR) applications for consumers. EkaCare seeks enthusiastic senior candidates to develop Large Language Models around medical/clinical data. We look forward to a candidate with Passion for problem-solving and taking end-to-end ownership of projects Extensive knowledge and prior work experience in machine learning (specifically in developing LLMs) Desire for a high-paced start-up ride Key Responsibilities : Formulate and implement data-driven solutions in the HealthTech domain: Building LLMs around healthcare data, wherein the work would involve creating datasets, continual pre-training, supervised fine-tuning, and preference alignment of models. Developing product-led AI solutions for various healthcare entities. Qualifications / Requirements Master / PhD degree in a relevant academic discipline (Preferred) 3-5 years of industry experience in building ML production-level pipelines. Extensive experience with LLMs (production-level deployment and fine-tuning) Strong track record of project delivery Experience Required: 3-5 years Full Time Employee Benefits: Insurance Benefits - Medical Insurance, Accidental Insurance Parental Support - Maternity Benefit, Paternity Benefit Program Mobility Benefits - Relocation benefits, Transfer Support Policy, Travel Policy Retirement Benefits - Employee PF Contribution, Flexible PF Contribution, Gratuity, NPS, Leave Encashment Other Benefits - Car Lease, Salary Advance Policy

?Find a Career With Purpose at Teva ? Keyword ? Location ?Select how often (in days) to receive an alert: ? Sr Mgr Biostatistics ? Date:? Jun 10, 2025 ?Location: ?Bangalore, India, 560064 ? Company:? Teva Pharmaceuticals ? Job Id:? 62254 ? Who we are ? ? The opportunity ?We are seeking a technically strong and motivated Senior Manager, Real World Data (RWD) Analytics to lead the execution of programming deliverables across a variety of clinical data sources. This individual will be responsible for delivering high-quality analytical outputs in alignment with real world evidence (RWE) study protocols, and statistical analysis plans. The role will play a critical part in supporting RWD projects by leveraging cutting-edge analytical tools and methods, enabling robust big data transformation, analysis, and reporting in collaboration with statisticians and study teams globally. ? How you ll spend your day ?Lead the development and execution of programming deliverables using RWD sources (e. g. , claims, EHR, registry) to support RWE studies and analyses. ?Partner with RWE statisticians and cross-functional study teams to align on analytical strategy and timelines, translate statistical analysis plans and protocols into efficient and reproducible analytical programs. ?Ensure compliance with internal standards, best practices, and regulatory requirements ?Support group head to recruit and build a team of RWD analysts based in India. ?Establish robust onboarding and training processes, documentation practices, and foster a continuous learning culture. ?Stay abreast of evolving big data analytical technology, with emphasis on advanced analytical tools and methods, AI/ML, process improvement and automation. ? Your experience and qualifications ?Master s degree or higher in Statistics, Biostatistics, Data Science, or a related quantitative field. ?Minimum 8 years of hands-on experience in programming and analytics in a pharmaceutical or healthcare research setting. ?Proven experience with RWD sources including claims, EMRs, and/or registry data. ?Prior experience managing or mentoring technical teams is preferred. ? Teva s Equal Employment Opportunity Commitment ?Teva Pharmaceuticals is committed to equal opportunity in employment. It is Tevas global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Who we are The opportunity The Clinical Programming Lead Manager is responsible for managing timely and accurate execution of all start-up activities and milestone deliverables for all assigned clinical trial projects. Clinical Programming lead manager is responsible for data definition by working with CRO and Third-Party Vendors (TPV) to ensure receipt of data in Teva data standard format, generating the database transfer specification (DTS), receiving and processing study related data. This position is also responsible for providing professional expertise and leadership through leading departmental tasks and taking initiatives in improving data management processes with focus on Data Operations activities. How you ll spend your day Manages multiple projects Likely to oversee contingent workers and/or vendors; Likely to provide training/Mentoring to others Ensures accurate set-up of data transfer processing Delivers assignments with quality and within timelines Provides strong programming support to CDISC based e-submission. Develops, debugs, and enhances SAS/ SQL programs to support to support study data batch processing and oversight listings Responsible to define case report forms (CRFs) and external (non CRF) data specifications in accordance with CDISC guideline and Teva standards Responsible to define data flow and additional startup activities related to study initiation Responsible to perform, supervise and manage day-to-day activities associated with receipt of clinical (CRF and non CRF) and operational (when relevant) data in accordance with study timelines Responsible to perform data handling activities/unblinding activities on an ongoing basis to ensure accuracy, reliability, integrity, consistency and completeness of the data prior to database lock and providing the final data to clinical programming and statistics after database lock Your experience and qualifications Bachelor s + 10 years or Master s + 8 years of professional experience in a pharmaceutical or clinical research setting as a programmer Bachelor s Degree/ Master s Degree/ PhD in Science, Statistics, Information Technology or equivalent combination of education and related work experience Thorough understanding of Clinical data, SDTM IG and Pinnacle 21 8+ years of SAS Programming experience The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner. Teva s Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Tevas global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

Facilitate key discussions with various stakeholders as requested by system owner/platform lead and provide SME technical support on system testingof the Core EDC Product,and anydata integrations (in and out)of EDC. Perform impact analysis for any change that happens on the EDCsystem Work with business and perform risk assessment during change implementations/systemupgradesor updates tointegrations Follow andparticipatein validation lifecycle for upgrades, changes, & new integrations Co-develop validation packagesin accordance withstandard operating procedures (SOPs). Provide support of code review and solutioningfor downstream customer requirements, including data extraction methods (SQL, Webservices, APIs) Activelyparticipatein business meetings and bringnew ideasto thetable Responsibleto solveday-to-day incidents, service requests andworktowards incident-reduction and automation. Also, update Service Now (ticket management tool) for all events with respect to the incidents, service requests,changesand problems. Constantly thrive to learn and upskill according to the organization s goals and demands. CreateGxpValidation Test cases inJiraXrayfor system/upgradetesting Perform validationtest executions in Jira Xray,for bothsystem testingand regression testing. Assistin creating or create UAT test cases that cover the essential business scenarios/use casesfor the business. Facilitateprocess requirementsgathering:capturing user stories, requirement analysis, data analysis, programming, database management, and systems integration. Mandatory Skills Extensive experience of usingMedidataRAVE UI(Classic or Rave EDC)to perform the following actions: Study build, edit checks programming, deployment to production andmigration Understanding aboutdifferent rolesand permissions in Rave Understanding of core configuration and clinical views Understanding of what data extraction capabilities there are Hands on Experience of Inbound Rave Web Services (egIVRS or discrepancy inputs) Experience of setting up Rave safety gateway (RSG) and SAE notifications Experience of setting up SAS extracts Experience on setting up Target Source Data Verification (TSDV) Hands on experience of being involved in URL upgrade(s) (Medidata release updates) Knowledge on system validation process / Application Life Cycle Management Must havestrong communicationskills and interpersonalskills Responsible to work on technical tasks to keep the Rave URL(s) andit sintegrations in a maintained state Adhere to AZ core ITIL guidelines and perform tasks as incident, change, problem etc. Working experience in clinicalstandard anddatacollection, clinical data conversion or clinical data programming/testing. Understandingof CDASH, SDTM,ADaMCDISC controlled TerminologyandFDA/ICH guidelines for clinical studydata Effective in stakeholder management, translating technical concepts, and working within team environments. Skilled in project management basics and creating clear technical documentation. Preferred Skills Hands on Experience of custom function,SASprogramming Knowledge on Coder/ Coder+setup&Lab setup Hands on Experience of outbound Rave Web Services (ODM Adapter, Biostats Adapter) Hands on Experience of Rave backend data model,sqlscript writing, stored procedures Hands-on knowledge in agile management tools like Service NOW Hands-on experience in performing system testing including authoring and executing testcases Passion for learning, innovating, and delivering valuable software to people. Any other programming languages/technical skillse.g: Python, JAVA, etc. Knowledge of other Medidata products and/or Cloud EDCtesting(Rave/Inform/Veeva)experience. Educational Requirements Bachelor or master sdegree in computer science or life science related discipline with IT/CRO/Pharma experience with total of8+ years of experience

Transform healthcare through innovation. At Sanofi, we're not just developing treatments we're pioneering the future of healthcare by harnessing the power of data insights and responsible AI to accelerate breakthrough therapies. As an AI/ML Scientist on our AI and Computational Sciences team, you'll: Drive innovation that directly impacts patient outcomes Collaborate with world-class scientists to solve complex healthcare challenges Apply advanced AI techniques to increase drug development success rates Shape the responsible use of AI in life-saving medical research Be part of a mission that matters. Help us transform data into life-changing treatments and join a team where your expertise can make a meaningful difference in patients lives. Our Team : The AI and Computational Sciences team is a key team within R&D Digital, focused on image, omics, wearable sensor data, and clinical data analytics. This team plays a critical role in bridging the gap between general purposed digital products and specific project needs. We are looking for a skilled AI/ML Data Scientist to join our elite AI and Computational Sciences team and harness cutting-edge AI to revolutionize healthcare. As a key player within R&D Digital, you'll transform complex data into life-changing medical breakthroughs. Impact you'll Make Drive innovation across multiple high-impact domains: Precision Medicine: Develop patient response prediction models that personalize treatments Advanced Omics Analysis: Pioneer cell type and cell stage quantification techniques Advanced Image/Video Analysis: Lead application of state-of-art computer vision methods for gaining unprecedented insights about drug efficacy from medical images/videos Digital Health: Design novel biomarkers from wearable sensor data Biological Insights: Create enzyme property prediction algorithms and conduct disease pathway analyses Your Growth Journey Technical Mastery: Develop expertise across image analysis, time series modeling, GenAI, AI Agents, and explainable AI Scientific Impact: Publish in top-tier AI/ML journals and secure patents that protect groundbreaking innovations Global Influence: Deploy solutions that impact patients worldwide Your Environment Elite Team: Work alongside AI/ML experts and drug development experts in an agile, high-performance environment Cutting-Edge Resources: Access Sanofis state-of-the-art cloud infrastructure and data platforms Continuous Learning: Receive mentorship and training opportunities to sharpen your leadership and AI/ML skills Join Our AI-First Vision Develop your skills through world-class mentorship and training Chase the miracles of science to improve peoples lives Ready to transform healthcare through the power of AI? Main Responsibilities : Research Phase Excellence Design and implement AI models for target identification and validation using multi-omics data (genomics, proteomics, transcriptomics) Develop predictive algorithms to molecular design for compound selection and accelerate lead optimization Create computer vision systems for high-throughput screening image analysis and cellular phenotyping Clinical Development Innovation Engineer digital biomarkers from wearable sensors and mobile devices to enable objective, continuous patient monitoring Implement advanced time-series analysis of real-time patient data to detect early efficacy signals Design AI-powe'red patient stratification models to identify responder populations and optimize trial design Multi-Modal Data Integration Architect systems that harmonize diverse data types (imaging, omics, clinical, text, sensor) into unified analytical frameworks Develop novel feature extraction techniques across modalities to enhance predictive power Create visualization tools that present complex multi-modal insights to clinical teams Scientific Impact Collaborate with cross-functional teams to translate AI insights into actionable drug development strategies Present findings to scientific and business stakeholders with varying technical backgrounds Publish innovative methodologies in top-tier scientific and AI/ML journals Contribute to patent applications to protect novel AI/ML approaches Experience : 3 to 5 years of experience in AI/ML and computational model development on multimodal data like omics, biomedical imaging, text and clinical trials data Key Functional Requirement: Demonstrated track record of successful AI/ML project implementation 3-5 years of experience in computational modeling or AI/ML algorithm development, or any other related field Deep understanding and proven track record of developing model training pipelines and workflows Excellent communication and collaboration skills Working knowledge and comfort working with Agile methodologies Technical Skills : Programming Proficiency: Advanced Python skills with experience in ML frameworks (PyTorch, TensorFlow, JAX) Machine Learning: Deep expertise in supervised, unsupervised, and reinforcement learning algorithms Drug discovery: molecular design, docking, binding site prediction, mRNA vaccine design, ADMET property, protein structure prediction, molecular dynamics simulation Deep Learning: Experience designing and implementing neural network architectures (CNNs, RNNs, Transformers) Computer Vision: Proficiency in image processing, segmentation, and object detection techniques (SAM, ViT, Diffusion Models, MediaPipe, MMPose, MonoDepth, VoxelNet, SlowFast, C3D) Natural Language Processing: Experience with large language models, text mining, and information extraction (OpenAI, Claude, Llama, Qwen, Deepseek model series) Time Series Analysis: Expertise in analyzing temporal data from sensors and wearable devices (HAR foundation models, compliance detection models) Omics Analysis: Knowledge of computational methods for protein genomics, proteomics, or transcriptomics data Cloud Computing: Experience deploying ML models on cloud platforms (AWS) Tools and Technologies : Data Processing: Experience with data pipelines and ETL processes Version Control: Proficiency with Git and collaborative development workflows, Docker MLOps: Experience with model deployment, monitoring, and maintenance Visualization: Ability to create compelling data visualizations (Matplotlib, Seaborn, Plotly) Experiment Tracking: Familiarity with tools like MLflow, Weights & Biases, or similar platforms Soft Skills : Strong scientific communication abilities for technical and non-technical audiences Collaborative mindset for cross-functional team environments Problem-solving approach with ability to translate business needs into technical solutions Self-motivated with capacity to work independently and drive projects forward Education : PhD/MS/BE/BTech/ME/MTech in Computer Science and Engineering, AI/ML, other relevant engineering discipline, Computational Biology, Data Science, Bioinformatics or related fields (with equivalent experience) Preferred : Publications or public github Languages : English Why Choose us Bring the miracles of science to life alongside a supportive, future-focused team Discover endless opportunities to grow your talent and drive your career, whether it s through a promotion or lateral move, at home or internationally Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs Opportunity to work in an international environment, collaborating with diverse business teams and vendors, working in a dynamic team, and fully empowe'red to propose and implement innovative ideas.

Clinical Data Programming Lead (SAS + EDC) - Bangalore/Chennai (Hybrid) The Clinical Data Programming Lead role is part of the Investigator Payments Group (IPG) and will be involved in the programming, delivery and oversight of data integration solutions between the Electronic Data Capture (EDC) system, the Clinical Trial Management System (CTMS) and our payment entitlement calculation system (APECS). The Clinical Data Programming Lead provides support to and acts as a back-up for the IPG Manager. To effectively assist the IPG Manager in leading the activities for those under his/her jurisdiction in a manner that ensures all timeframes and targets are met. The Clinical Data Programming Lead is responsible for managing multiple projects in accordance with established timelines and quality standards. The Clinical Data Programming Lead participates in activities related to specification development, programming, validation and quality assurance of study data deliverables and applies expert experience and knowledge. Serves as the programming lead and SME for Patient Data Integration (PDI) on all new eligible studies. Oversees the setup and maintenance of programming deliverables including setup/monitoring of automated schedules and other supporting systems. Provides programming/technical oversight, quality assurance and mentoring for other assigned Clinical Data Programmers. Trouble-shoots and solves programming issues and/or system integration issues as needed. Job Location : Chennai / Bangalore Experience required: 5+ years of experience clinical data programming and delivery Successful handling of multiple tasks and timelines. Team player with strong verbal and written communication skills (English). Advanced knowledge of the clinical data programming development life cycle. Experience in clinical data programming and the ability to review and evaluate clinical data. Extensive problem solving skills for tasks/functions related to his/her group. Strong organizational, prioritization and time management skills. Ability to perform assigned tasks with little supervision. Strong ability to learn new technologies, applications and techniques. Have proven SAS programming experience and be familiar with handling data extracts from different EDC systems. In particular, Medidata Rave and Veeva CDMS. Education requirements: Bachelor s degree in information systems, science or related discipline or relative experience required. #LI-SG1 Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Clinical Data Programming Lead (SAS + EDC) - Bangalore/Chennai (Hybrid) ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development The Clinical Data Programming Lead role is part of the Investigator Payments Group (IPG) and will be involved in the programming, delivery and oversight of data integration solutions between the Electronic Data Capture (EDC) system, the Clinical Trial Management System (CTMS) and our payment entitlement calculation system (APECS). The Clinical Data Programming Lead provides support to and acts as a back-up for the IPG Manager. To effectively assist the IPG Manager in leading the activities for those under his/her jurisdiction in a manner that ensures all timeframes and targets are met. The Clinical Data Programming Lead is responsible for managing multiple projects in accordance with established timelines and quality standards. The Clinical Data Programming Lead participates in activities related to specification development, programming, validation and quality assurance of study data deliverables and applies expert experience and knowledge. Serves as the programming lead and SME for Patient Data Integration (PDI) on all new eligible studies. Oversees the setup and maintenance of programming deliverables including setup/monitoring of automated schedules and other supporting systems. Provides programming/technical oversight, quality assurance and mentoring for other assigned Clinical Data Programmers. Trouble-shoots and solves programming issues and/or system integration issues as needed. Job Location : Chennai / Bangalore Experience required: 5+ years of experience clinical data programming and delivery Successful handling of multiple tasks and timelines. Team player with strong verbal and written communication skills (English). Advanced knowledge of the clinical data programming development life cycle. Experience in clinical data programming and the ability to review and evaluate clinical data. Extensive problem solving skills for tasks/functions related to his/her group. Strong organizational, prioritization and time management skills. Ability to perform assigned tasks with little supervision. Strong ability to learn new technologies, applications and techniques. Have proven SAS programming experience and be familiar with handling data extracts from different EDC systems. In particular, Medidata Rave and Veeva CDMS. Education requirements: Bachelor s degree in information systems, science or related discipline or relative experience required.

Job Title: Tech BA Key Responsibilities As a Tech BA, you will: Requirements Management: Understand and document business and data requirements across clinical domains, translating them into actionable technical tasks. Jira & Agile Management: Manage and maintain Jira boards for the Data Engineering team, including grooming stories, tracking progress, and coordinating with developers, QA, and stakeholders within an Agile/Scrum delivery model. Stakeholder Liaison: Act as a liaison between product, engineering, and external stakeholders to clarify requirements and ensure alignment across teams. Data Documentation: Drive the creation and maintenance of data entity mapping documentation between legacy systems and Medidata CTMS. ETL & Data Pipeline Validation: Collaborate with engineering leads to support ETL and data pipeline validation, including defining edge cases and expected behaviors. UAT Support: Support User Acceptance Testing (UAT) efforts for data integration/migration projects by coordinating validation cycles with clinical users and data stakeholders. Risk & Issue Resolution: Identify risks, gaps, or inconsistencies in incoming data requirements and proactively resolve them. Data Migration Participation: Participate in data migration planning and execution. Mandatory Skills & Experience Technical & Domain Proficiency: Clinical Domain: Strong understanding of clinical data and clinical workflows . BA/Technical BA Experience: Minimum of 6 years of experience as a Business Analyst or Technical BA in the clinical trials or life sciences domain. Agile Tools: Experience with Jira, Confluence , and Agile/Scrum delivery models . Data Fundamentals: Familiarity with data models, data structures, and relational data concepts (SQL knowledge is a plus). Documentation: Proven ability to create clear, structured documentation (e.g., data dictionaries, mappings, process flows). Experience & Qualifications: Demonstrated experience in understanding and documenting business/data requirements and translating them into technical tasks. Experience with previous system-to-system migrations (strong plus). Essential Professional Skills Communication: Strong written and verbal communication skills with the ability to simplify complex topics for non-technical stakeholders. Project Management: Ability to manage multiple workstreams and keep deliverables on track. Preferred Qualifications Experience with clinical data migrations (e.g., from Veeva, Oracle, or other CTMS systems to other systems). Understanding of ETL pipelines or working experience with data engineering teams. Knowledge of CTMS, eTMF, EDC/Rave , or other clinical trial technologies.

Title Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical Data Coder to join our Clinical Coding & Support team in Mumbai, India. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous coding, pharmacy, or nursing expertise and can develop and grow your career even further, then this is the opportunity for you! Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Perform accurate coding of medical terms and medications utilizing industry-wide standards as well as company standards; Coordinate the assignment of appropriate dictionaries for meeting study requirements; and Develop and maintain coding guidelines Qualifications Bachelor Degree in Nursing, or more advanced clinical degree; Experience with using MedDRA and WHO Drug dictionaries; and Experience working with clinical trials or within the pharmaceutical environment is preferred. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Roles & Responsibilities:- Experience in medical writing domain across different therapeutic areas in clinical documents including protocol, informed consent document, clinical study report, investigator's brochure, clinical summary of pharmacology, clinical overview (efficacy and safety); and/or safety documents like Development safety update report (DSUR), Periodic benefit risk evaluation report (PBRER), Risk Management Plans (RMPs), addendum to clinical overviews (aCOs) Experience in preparation of clinical/safety documents necessary for national and international regulatory submissions to the US, European and other regulatory agencies preferred Experience in writing and review of scientific/clinical documents preferred Knowledge of clinical research domain, ICH GCP principles and regulatory requirements preferred Effective coordination and presentation skills - Good organization and time management skills Exceptional interpersonal, verbal and written communication skills

Role & responsibilities Designing and implementing clinical data collection systems and tools Coordinating with investigators and other healthcare professionals to gather and interpret clinical data Overseeing the data management process, including data collection, entry, verification, and cleaning Ensuring the integrity, accuracy, and security of all clinical data Preparing and maintaining documentation related to data management activities, such as data management plans and standard operating procedures Ensuring compliance with regulatory standards and guidelines, including Good Clinical Practice (GCP) Working closely with biostatisticians and other data scientists to analyze clinical data and generate statistical reports Participating in the preparation of clinical study reports and other regulatory documents Training and supervising data management staff Responsible for coding and categorizing data appropriately Address data queries and discrepancies, and make necessary corrections Develop and maintain data management plans and documentation Participate in the preparation of reports and manuscripts Preferred candidate profile Clinical Database Design Edit check identification and programming SAS programming (optional) Qualifications Proven work experience as a Clinical Data Manager or similar role Experience in a clinical or pharmaceutical environment Strong understanding of data management principles and practices Excellent knowledge of data analysis and reporting tools Experience with Electronic Data Capture (EDC) systems Strong attention to detail and problem-solving abilities Ability to handle multiple tasks and meet deadlines Interested Candidates kindly send me updated resumes to pitchireddy.t@hetero.com

Summary Provide expert support and functional and technical knowledge to ensure the scientific integrity/validity for clinical development, early development, and/or research projects. Participate in the full lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. Provide statistical support for regulatory submissions including planning, analysis and reporting of clinical safety and efficacy summaries. May also provide statistical support to research or other R&D areas. -Responsible for advising/leading the planning, development & implementation of Industry (CDISC and regulatory) compliant, high quality, clinical data standards, infrastructure or automation technologies. Providing expert support and stellar customer focus to business users and teams on their use, including: -Data standard collection tools in EDC (CRFs, edits checks, derivations, core configurations) -Data transfer specifications -Analysis data/TFL standards/Define -Automation solutions / technologies -Business infrastructure, business rules and guidelines. About the Role Key Responsibilities Study Level-Responsible for all statistical tasks on the assigned trials, and perform these tasks for mid- to high- complexity trial independently with peer review/input as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plan, reporting activities. Contribute to planning and execution of exploratory analyses, and/or PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation. Initiate, drive and implement novel methods and innovative trial de-signs in alignment with the Lead Statistician. Explain statistical methodology and interpret analysis results. Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities and other drug development activities, as required. Contribute to interactions with external review boards/ethics committees, ex-ternal consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Represent the Biostatistics & Pharmacometrics Line Function on cross-functional teams for the assigned trials. Responsible for functional alignment and ensuring line function awareness throughout the assigned trials. Collaborate with other line functions. Explain statistical concepts in an easily understandable way to non-statisticians and provide adequate statistical justifications for actions/decisions/statements, when required. Establish and maintain sound working relationships and effective communication within the Clinical Trial Team and Biostatistics & Pharmacometrics team. Oversee all Biostatistics resources and deliverables for assigned trials. En-sure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities. Project level- May be a core member of an early project team for a low-complexity program and represents Biostatistics and Pharmacometrics as part of development plan with oversight. Collaborate with clinical, regulatory and other strategic functions to drive quantitative decision making in assigned indications/program with oversight. Collaborate cross-functionally (e. g. data management, programming, medical writing) to ensure timeliness and quality of statistical deliverables. Propose and implement innovative designs and methods to optimize dose finding and drug development. Contribute to planning, prioritization and tracking of program level biostatistics activities and effective partnership with vendors. Significantly contributes to project team preparation for HA Advisory Committees and meetings. Franchise or Global Line Function level: Significantly contribute to initiatives at global line function level Enterprise level- Actively contribute to cross-functional organizational / process /scientific consulting improvement initiatives. Contribute to the review and implementation of health authority guidance. Identify, evaluate, and promote the use and the acceptance within and out-side the organization, of innovative methods, through scientific collaborations, publications in scientific peer reviewed journals, presentations and chairing sessions at professional meetings. External level- Contribute to interactions with external review boards/ethics committees, ex-ternal consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Role Requirements : MS (in Statistics or equivalent) with 7+ years relevant work experience or PhD (in Statistics or equivalent) with 3+ years relevant work experience Fluent English (oral and written) Good communication and presentation skills Influences decisions that directly impact the trial/project and team ability to deliver objectives. Experience in all tasks of a statistician at the trial/experiment level and demonstrated independence in the role. Proven knowledge and expertise in statistics and its application to clinical trials; able to explain statistical designs and concepts. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modelling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Proficiency in use of statistical software packages (e. g. SAS, R). Good knowledge of drug development and Health Authority guidelines. Demonstrated effectiveness working on a multidisciplinary team to achieve team objectives. Good understanding of Franchise/Therapeutic Area and or regulatory activities. Good project management and matrix leadership skills. Ability to collaborate well with non-statistical functions. Good business ethics Why Novartis: Commitment to Diversity and Inclusion: Accessibility and accommodation Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork. novartis. com/network Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together? https://www. novartis. com / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork. novartis. com/network Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

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. com/working-with-us . Create SAS programs to generate derived analysis data sets and content for tables, listings, and figures; Perform programming validation to ensure quality of analysis d atasets and programming outputs Provides programming support for project teams, including development of programming strategies, standards, specifications and programmed analysis Support the electronic submission preparation and revi e w Reviews key planning documents (e. g. , statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programmi ng assumptions and requirements ; Assesses impact on programming activities Interacts with vendors regarding project standards, programming conventions, programming spec ifications and file transfers Provides leadership for ensuring quality of Global Biometric and Data Sciences ( GB D S) deliverables by consistently applying s tandards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work p ractices Identifies opportunities for increased efficiency and consistency within GB D S and our interactions with strategic vendors Independently leads and / or performs programming assignments with minimal supervision Support improvement initiatives Minimum Requirements: Bachelor s degree in statistics, biostatistics, mathematics, computer science or life sciences required . At least 5 years programming experience in industry recommended . For US positions: US military experience will be considered towards industry experience . Demonstrated proficiency in using SAS , R or other programming languages to produce deriv ed analysis datasets and TFLs. Have in -depth understanding of clinical data structure ( e. g. CD I SC standards) and relational database. Demonstrated skills in using software tools and applications, e. g. , MS office, XML, Pinnacle 21. Demonstrated ability in the handling and processing of upstream data, e. g. , multiple d ata forms, workflow, eDC , SDTM. Demonstrated ability in providing outputs to meet downstream requirements, e. g. , ADaM , Data Definition Table, e-submission. Have good understanding of regulatory, industry, and technology standards and requirements. Have good knowledge of statistical terminology, clinical tests, medical terminology and protocol designs. Demonstrated ability to work in a team environm ent with clinical team members. Preferred Requirements : Minimum of 5 years clinical / statistical programming experience within pharmaceutical clinical development - Supporting regulatory filings ( e. g. NDA, BLA, MAA) Knowledge of the drug development process, clinical trial methodology , statistics and familiarity with global regulatory requirements Experience in other software packages ( e. g. R) Experience with the Linux operating system 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. 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. 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. com . Visit careers. bms. com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers. bms. com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Preparing interview questions, communicating and interacting with patients,and summarizing results. Liaising with laboratories regarding research findings. Monitoring the study to ensure that it complies with protocols. Directing the collection, labelling, storage, and transport of all specimen. Noting the clinical data from records, recording dietary intake patterns, physical activity, sample separation, and patient follow-up. Analyze data using various statistical methods and maintain accurate and complete records. Co-ordinate with Bioinformaticians, Genetic Counselors, Clinicians, and clinical geneticists for data analysis. Reviews and processes orders for laboratory procedures for patient samples. Demonstrate strong scientific and communication skills. Maintain precise and up-to-date documentation of the ethics, biosafety committee, and DSIR. Overseeing the trouble-free running of patient's enrolment for research studies. M.Sc./B.Sc. in life science (Biotechnology/Medical Microbiology / Microbiology / Medical Biochemistry) Minimum of 1 year work experience for M.Sc./B.Sc., and expertise in counseling patients and dry lab techniques.

A productive, hands on programmer who applies technical knowledge and practical experience to deliver statistical programming deliverables to support assets and study teams with limited supervision early in role and independently later in role. Ensures excellence in th e programming of analysis ready datasets, tables, listings, and figures for which they are responsible Ensures adherence to high quality programming standards in their daily work. Accountable for the quality and timely delivery of datasets and displays required for their clinical study reports as well as other asset level deliverables they may be programming. Ensures appropriate documentation and QC across the lifespan of the study for all of their programming deliverables. Exhibi ts routine and occasionally complex problem solving skills, seeking direction when appropriate. Works with statisticians and programming leads to ensure clear specifications for their programmed deliverables are in place. Will be knowledgeable in core safe ty standards as well as TA standards pertinent to their project, may aid in development of standards necessary for their study May contribute to department level initiatives. QUALIFICATIONS Bachelor or Master (prefer red) Degree in Statistics, Biological Sciences, IT, or related field. At least 3 years relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency. Statistical Programming and SAS hand - on experience Clinical trials expertise with an understanding of data operations required for the reporting of clinical trial data. Good understanding of ICH and regulatory guidelines Working knowledge of clinical data and relevant data standards Work Location Assignment: Flexible Work Location Assignment: Hybrid Medical #LI-PFE

Overview: Dozee Health AI is a pioneer in Contactless Remote Patient Monitoring (RPM), proven to drive transformation at scale. Headquartered in Bengaluru, India, Dozee has emerged as India s no. 1 RPM Company. We are seeking visionary individuals to help us in this very exciting journey. As a part of our dynamic team, you ll have the opportunity to collaborate with top healthcare providers in the country, applying AI-powered RPM solutions to tackle some of the most pressing challenges in healthcare - enhancing staff efficiency, improving patient outcomes, and pioneering the next generation of care models. Project Overview: We are conducting a post-market clinical study to evaluate the accuracy and reliability of the Dozee device, a contactless remote patient monitoring (RPM) system. The study involves comparing real-time vitals captured by the Dozee device against standard manual readings across a sample set of hospital patients. Role Summary: We are looking for experienced and detail-oriented Registered Nurses to support this study by measuring, recording, and comparing vital parameters such as heart rate, respiratory rate, SpO , and temperature. The data collected will help validate and improve the Dozee device. Responsibilities Accurately measure vital signs (heart rate, SpO , respiratory rate, blood pressure, and temperature) using standard hospital-grade equipment. Record and log readings systematically in the study database/formats. Ensure synchronized collection of manual and device-generated vitals for comparison. Coordinate with patients and hospital staff to facilitate smooth data collection without disrupting routine care. Follow established protocols and SOPs for clinical data collection and confidentiality. Report any deviations, errors, or inconsistencies in real-time to the project lead. Maintain hygiene and safety standards as per hospital norms. Requirement GNM / B.Sc. Nursing from a recognized institution. Registered with the State Nursing Council.0 to 2 years of clinical experience in patient care or monitoring. Open to work from our client hospitals. Experience working in hospital settings (ICUs, general wards, etc.) is a plusBasic understanding of medical equipment and digital vitals monitors. Skills & Competencies: Excellent attention to detail and accuracy in recording. Strong communication skills to coordinate with patients and medical staff. Ability to follow research protocols and timelines. Comfortable using mobile devices/tablets for data entry.

Medical Coding Specialist Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials. Job Summary Coordinates the coding of terms for clinical trials, including review of automatically coded terms, manually coding terms, and working with the Clinical team to assure accuracy and consistency. Works under the direction of the Manager, Medical Coding for day to day technical tasks, project assignments and on-time quality delivery. Primary Responsibilities Manually encode medical terms which are not automatically encoded by the data management system Ensure consistency of the coding of terms within and across projects Communicate timely and effectively with coding team and Manager, Medical Coding of any issues, risks, concerns or technical needs regarding coding activities Contribute to and review Data Management Plans, emphasizing the Coding Conventions therein Provide input into User Acceptance Testing (UAT), specifically for coded term fields, if required Provide information to the project team about coding rationale, if requested Communicate with Clinical Data Management and Clinical Programming staff when issues arise requiring queries or system changes Adhere to all aspects of the SDC s quality system Comply with SDC s data integrity & business ethics requirements Perform other related duties incidental to the work described herein Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements Working knowledge of clinical trials and coding specialist role in the drug development process Excellent organizational skills Effective communication skills, both written and verbal Technical skills including: MedDRA, WHODrug Global, Microsoft Office Medidata Coder experience Certified MedDRA Coder (CMC) preferred Ability to utilize WHODrug Insight Ability to work as a part of a team The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified. Required Skills Working knowledge of clinical trials and coding specialist role in the drug development process Excellent organizational skills Effective communication skills, both written and verbal Technical skills including: MedDRA, WHODrug Global, Microsoft Office Medidata Coder experience Certified MedDRA Coder (CMC) preferred Ability to utilize WHODrug Insight Ability to work as a part of a team Ability to work under pressure and meet timelines Education or Equivalent Experience Bachelor s degree in applied or life science and at least 2 years of experience in clinical data medical coding. Why SDC We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits. We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment. We strive to provide a place of belonging to our employees with fun and engaging activities from SDC s culture club. We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry. With a proven track record, SDC has been successfully executing client clinical programs since 2005. Take a look at how you can join our team! #LI-Hybrid

Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Associate Qualifications: BE/BTech/BCA Years of Experience: 1 to 3 years What would you do? You will be part of our Life Sciences R&D division, which offers a comprehensive range of services across the life sciences sector. This includes Clinical Data Management, regulatory services, pharmacovigilance, and patient services solutions. Employees within this clinical capability will join one of our sub-offerings, such as Clinical Database build and Clinical Reporting. In these roles, you will support leading biopharma companies in realizing their vision, enhancing outcomes by focusing on the patient and integrating scientific expertise with unique insights into the patient experience.The Clinical Reports Programming team is dedicated to developing and maintaining clinical reports for clinical trials. This involves utilizing PL/SQL, SQL, and Clinical SAS programming skills to create these reports. The team also integrates data from various sources such as EDC, Labs, and IRT. Ensuring that all reports comply with regulatory standards and guidelines is a crucial part of their work. They implement stringent quality assurance processes to uphold the highest levels of data integrity and report accuracy. Additionally, the team collaborates closely with clinical operations, biostatistics, and other departments to ensure the reports meet the needs of all stakeholders, facilitating informed decision-making based on accurate and timely data.Develop and review complex reports, 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? Oracle Procedural Language Extensions to SQL (PLSQL) Structured Query Language (SQL) Experience in writing programs using Clinical SAS Clinical Database Programming Clinical Data Management SAS Clinical Adaptable and flexible Ability to perform under pressure Problem-solving skills Ability to establish strong client relationship Agility for quick learning Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification BE,BTech,BCA

Skill required: Clinical Data Services - Clinical EDC Build Designation: Clinical Data Svs Associate Qualifications: BE/BTech/BSc Years of Experience: 1 to 3 years What would you do? You will be part of our Life Sciences R&D division, which offers a comprehensive range of services across the life sciences sector. This includes Clinical Data Management, regulatory services, pharmacovigilance, and patient services solutions. Employees within this clinical capability will join one of our sub-offerings, such as Clinical Database build and Clinical Reporting. In these roles, you will support leading biopharma companies in realizing their vision, enhancing outcomes by focusing on the patient and integrating scientific expertise with unique insights into the patient experience.The Clinical Database Management team is committed to developing and maintaining databases for clinical trials, which includes creating Case Report Forms (CRFs) and developing Edit and Validation Checks using programming skills like C# and PL/SQL. They also support data integration from various external sources such as labs and Interactive Response Technology (IRT). The team ensures compliance with regulatory standards and guidelines, maintaining high levels of data quality and security. Additionally, they continuously seek to improve database processes and tools by leveraging the latest technologies and best practices to enhance efficiency and accuracyDevelop clinical study databases by building electronic case report forms and program edit checks as per specifications. Support any updates or changes to the study database (e.g. Protocol amendments) through the change control process. What are we looking for? Oracle Procedural Language Extensions to SQL (PLSQL) Structured Query Language (SQL) C, C++, C# Programming Skills Experience in writing programs using Javascript Clinical Database Programming Clinical Data Management SAS Clinical Adaptable and flexible Ability to perform under pressure Problem-solving skills Ability to establish strong client relationship Agility for quick learning Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification BE,BTech,BSc

Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Sr Analyst Qualifications: BE/BTech/MCA Years of Experience: 5 to 8 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings, 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 automation team focuses on the development and implementation of innovative concepts and application for our client across different accounts in operations. The team is responsible for designing and implementing highly interactive scalable web apps and prototypes at enterprise level.You will be expected to develop and implement complex APIs based on requirements using different tools/techs such as .Net, Java, PL/SQL, Python, Full- Stack Developer. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Agility for quick learning Ability to work well in a team Bachelor's degree in Computer Science, Information Technology, Engineering or any computer related discipline. Work experience of at least 3 year in relevant industries (Financial Services, Network, Utilities, Health Care, Marketing, Pharma, Retail etc.). Work experience of at least 4 years in designing, coding, APIs, testing, debugging, documenting, and implementing enhancements and fix solutions. Work experience in Implementing APIs based architecture frameworks. Aptitude to learn, think creativity to solve real world business problems, and work in a global collaborative team environment. Proficient verbal and written communication skills in English. Roles and Responsibilities: Work as a technical lead to architect and develop innovative concepts and applications for our clients across different accounts in Operations. Design and implement highly interactive, scalable web apps and prototypes at Enterprise level. Build and modify high-performance APIs and Monitor API performance and troubleshoot issues promptly. Implement APIs based on architecture frameworks and guidelines. Work with DevOps engineers to integrate new code into existing continuous integration (CI) and continuous delivery/deployment (CD) pipelines. Able to lead Automation initiatives within his account. Work closely with the team and client to understand requirements and guiding them to deliver the most effective solution. Participate in the development of automation solutions, from prototyping new functionality and technologies to integrating them in our overall products and offerings, thus developing expertise and skills in this domain. Collaborate with frontend and backend developers to define API requirements and Ensure API security and authentication mechanisms are robust. You should be able to pilot and deploy automation solutions at scale. Partner with the testing team to ensure applications/components are fully functional. Oversee and fix any defects or performance problems discovered in testing. Participating in analyses of requirements as well as functional design whenever necessary. Be involved in the design of the solution. Performing design, coding, application maintenance and testing activities. Take ownership of the successful implementation of the solution. Qualifications BE,BTech,MCA

Key Responsibilities: Scientific & Medical Expertise Serve as a subject matter expert in neuroscience, providing high-quality scientific and medical support to internal and external stakeholders. Stay updated on the latest scientific advancements, treatment guidelines, and competitive landscape in neuroscience. Provide scientific training to internal teams, including commercial and market access teams. Stakeholder Engagement & Medical Communication Develop and maintain strong relationships with Key Opinion Leaders (KOLs), healthcare professionals (HCPs), and academic institutions. Lead scientific discussions and advisory boards to gather insights and address unmet medical needs. Deliver presentations at medical and scientific meetings, congresses, and symposia. Medical Strategy & Evidence Generation Contribute to the development and execution of the Medical Affairs Plan for neuroscience. Collaborate with cross-functional teams to provide medical input into brand strategies and regulatory submissions. Compliance & Ethical Standards Ensure all medical activities align with company policies, industry regulations, and ethical guidelines. Review promotional and non-promotional materials for scientific accuracy and compliance with regulatory standards. Key Requirements: Education: MD, BDS, PhD, or PharmD preferred (MSc or MBBS with relevant experience may be considered). Experience: Minimum 2 years of experience in Medical Affairs or a related role in the pharmaceutical industry, preferably in neuroscience. Scientific Knowledge: Strong understanding of neuroscience disease areas, treatment landscapes, and clinical data interpretation. Stakeholder Engagement: Experience in engaging with KOLs, HCPs, and scientific societies. Communication Skills: Excellent written and verbal communication skills, with the ability to translate complex scientific data into meaningful insights. Regulatory & Compliance Knowledge: Familiarity with local and global regulatory frameworks (e.g., ICH-GCP, FDA, EMA, DCGI guidelines).

Primary Responsibilities: Develop and refine study designs to ensure scientific rigor and alignment with research objectives. Analyse data according to study statistical plan tailored to the studys specific needs, ensuring that data collection methods align with intended analysis strategies. Compile comprehensive reports for relevant committees and funding agency, that summarize the study progress, challenges encountered, and future directions. Organize project meetings to manage progress and timelines. Preparing manuscripts for scientific communication. Site monitoring visits and audits: manage the monitoring visits and address any deviations or concerns related to study execution. Execute action points as indicated by the study monitor during the visit and generate closure reports. Data Audits: Perform thorough audits of collected data to verify accuracy, completeness, and adherence to the study design and ethical standards. Team Collaboration: Work closely with a multidisciplinary team, including data managers, statisticians, other researchers, and clinical staff, to ensure that all aspects of the study are Minimum Essential Qualifications: First Class Post Graduate Degree, including the integrated PG degrees, with PhD Second Class Post Graduate Degree, including the integrated PG degrees, with PhD and with For Engineering/IT/CS- First Class Graduate Degree of four years with three years experience Desirable Qualifications/experience: Experience in clinical or health services research, including expertise in study design and research methodology. Experience in conducting/managing operational feasibility studies Minimum 3 years of experience in clinical data analysis, statistical analysis of large datasets, or Experience in statistical methods, exploratory data analysis, multivariate data analysis, linear, logistic, Poission regression with diagnostic checking, survival analysis, and their implementation in R, SAS, Graphpad prism, or other statistical software. Excellent written and oral communication skills, capable of effectively presenting research findings and writing complex reports. Demonstrated ability to lead and manage research projects, including coordination of Knowledge of regulatory standards and ethical guidelines pertinent to clinical research. Strong attention to detail and commitment to accuracy. Good organizational skills and ability to manage multiple tasks.

PURPOSE Performs and oversees data management activities in order to provide high quality data that meets client/project needs. Ensures that data is processed and tracked in alignment with regulatory and quality standards. RESPONSIBILITIES Serve as main point of contact for Data Management for 5 to 10 studies, or serve in a leadership role to a specific DM Task. Manage delivery of projects through full eCOA data management study life-cycle. Manage eCOA DM project timelines and quality; determine resource needs; identify out-of-scope work. Perform comprehensive data management tasks including data review, writing and resolving data clarifications. Provide support in database design activities for technologies not requiring extensive programming. Perform comprehensive quality control procedures. Independently bring project solutions to the eCOA team. Solve issues through using the global issue escalation/communication plan. Consult with eCOA ops Group for process issues; communicate ideas for process improvement. Assist in developing and implementing new technology. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with eCOA team. Interact with other study team members to negotiate timelines and responsibilities. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES Good understanding of clinical drug development process and Data Management activities. Background in, medical terminology, Pharmacology, Anatomy, and Physiology. Excellent organizational, communication, and data management skills (detailed oriented). Ability to establish and maintain effective working relationships with coworkers, managers and clients. Ability to work within a team and with a good level of autonomy. MINIMUM REQUIRED EDUCATION AND EXPERIENCE Bachelor s degree, or educational equivalence, in clinical, biological, or mathematical sciences or related field or nursing qualification with 2-4 year clinical trials experience in function similar to DM; or equivalent combination of education, training and experience. PHYSICAL REQUIREMENTS Extensive use of telephone and face-to-face communication requiring accurate perception of speech Extensive use of keyboard requiring repetitive motion of fingers Regular sitting for extended periods of time

PURPOSE Performs and oversees data management activities in order to provide high quality data that meets client/project needs. Ensures that data is processed and tracked in alignment with regulatory and quality standards. RESPONSIBILITIES Serve as main point of contact for Data Management for 5 to 10 studies, or serve in a leadership role to a specific DM Task. Manage delivery of projects through full eCOA data management study life-cycle. Manage eCOA DM project timelines and quality; determine resource needs; identify out-of-scope work. Perform comprehensive data management tasks including data review, writing and resolving data clarifications. Provide support in database design activities for technologies not requiring extensive programming. Perform comprehensive quality control procedures. Independently bring project solutions to the eCOA team. Solve issues through using the global issue escalation/communication plan. Consult with eCOA ops Group for process issues; communicate ideas for process improvement. Assist in developing and implementing new technology. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with eCOA team. Interact with other study team members to negotiate timelines and responsibilities. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES Good understanding of clinical drug development process and Data Management activities. Background in, medical terminology, Pharmacology, Anatomy, and Physiology. Excellent organizational, communication, and data management skills (detailed oriented). Ability to establish and maintain effective working relationships with coworkers, managers and clients. Ability to work within a team and with a good level of autonomy. MINIMUM REQUIRED EDUCATION AND EXPERIENCE Bachelor s degree, or educational equivalence, in clinical, biological, or mathematical sciences or related field or nursing qualification with 2-4 year clinical trials experience in function similar to DM; or equivalent combination of education, training and experience. PHYSICAL REQUIREMENTS Extensive use of telephone and face-to-face communication requiring accurate perception of speech Extensive use of keyboard requiring repetitive motion of fingers Regular sitting for extended periods of time . 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

Work Flexibility: Hybrid What You will do - Identifies information sources and resources for local, regional, and global regulations Collects, organizes, and maintains files on local, regional, and global regulatory intelligence and other related information Monitors the regulatory environment (specific regulations, guidance and other relevant information by product types, geography, etc.) Provides information used to evaluate proposed products for regulatory classification and jurisdiction Researches requirements (local, national, international), applicable guidance and standards and options for regulatory submissions, approval pathways, and compliance activities Assists in the development of regulatory procedures and SOPs Collects and organizes information on requirements for regulatory, quality, preclinical, and clinical data to meet applicable regulations Organizes materials from preclinical and clinical studies for review and assists in the review process Compiles and organizes materials for pre-submission reports and communications Assists in the preparation of dossiers and pre-submission and submission packages for regulatory agencies Tracks the status of applications under regulatory review and provides updates to the regulatory team Maintains logs of communication and outcomes with regulators and other relevant internal or external stakeholders Assists in the scheduling of meetings with internal stakeholders and regulators and develops and organizes materials for these meetings What you will need- Education / Work Experience: BS in Engineering, Science, or related degree; or MS in Regulatory Science 4 + yrs experience Knowledge / Competencies: Time management skills, writing, coordination, and execution of basic regulatory items Clearly conveys information to peers, supervisors, and other stakeholders Assists in the preparation for meetings with regulatory agencies and other stakeholders; in the preparation of briefings and other information documents Communicates information on regulatory requirements to other departments and business units Composes routine communications with regulators and other key stakeholders Creates clarity and direction amid complexity and develops solutions for self, colleagues, and the organization Travel Percentage: None