276 Clinical Data Jobs - Page 2

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: Master s degree and 8 to 10 years of Information Systems experience OR Bachelor s degree and 10 to 14 years of Information Systems experience OR Diploma and 14 to 18 years of Information Systems 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.

Summary Are you passionate about the intersection of data, technology and science, and excited by the potential of Real-World Data (RWD) and AI? Do you thrive in collaborative environments and aspire to contribute to the discovery of groundbreaking medical insights? If so, join the data42 team at Novartis! At Novartis, we reimagine medicine by leveraging state-of-the-art analytics and our extensive internal and external data resources. Our data42 platform grants access to high-quality, multi-modal preclinical and clinical data, along with RWD, creating the optimal environment for developing advanced AI/ML models and generating health insights. Our global team of data scientists and engineers utilizes this platform to uncover novel insights and guide drug development decisions. As an RWD SME / RWE Execution Data Scientist, you will focus on executing innovative methodologies and AI models to mine RWD on the data42 platform. You will be the go-to authority for leveraging diverse RWD modalities patterns crucial to understanding patient populations, biomarkers, and drug targets, accelerating the development of life-changing medicines. About the Role Duties and Responsibilities: Collaborate with R&D stakeholders to co-create and implement innovative, repeatable, scalable and automated data and technology solutions in line with data42 strategy. Be a data Subject Matter Expert (SME), understand Real World Data (RWD) of different modalities, vocabularies (LOINC, ICD, HCPCS etc. ), non-traditional RWD (Patient reported outcomes, Wearables and Mobile Health Data) and where and how they can be used, including in conjunction with clinical data, omics data, pre-clinical data, and commercial data. Contribute to data strategy implementation such as Federated Learning, tokenization, data quality frameworks, regulatory requirements (submission data to HL7 FHIR formats conversion, Sentinel initiative), conversion to common data models and standards (OMOP, FHIR, SEND etc. ), FAIR principles and integration with enterprise catalog Define and execute advanced integrated and scalable analytical approaches and research methodologies (including industry trends) in support of exploratory and regulatory use of AI models for RWD analysis across the Research Development Commercial continuum by facilitating research questions. Stay current with emerging applications and trends, driving the development of advanced analytic capabilities for data42 across the Real-world evidence generation lifecycle, from ideation to study design and execution. Demonstrate high agility working across various cross-located and cross-functional associates across business domains (commercial, Development, Biomedical Research) or Therapeutic area divisions for our priority disease areas to execute complex and critical business problems with quantified business impact/ROI. Ideal Candidate Profile: PhD or MSc. in a quantitative discipline (e. g. , but not restricted to Computer Science, Physics, Statistics, Epidemiology) with proven expertise in artificial Intelligence / Machine Learning. 8+ years of relevant experience in Data Science (or 4+ years post-qualification in case of PhD). Extensive experience in Statistical and Machine Learning techniques: Regression, Classification, Clustering, Design of Experiments, Monte Carlo Simulations, Statistical Inference, Feature Engineering, Time Series Forecasting, Text Mining, and Natural Language Processing, LLMs, and multi-modal Generative AI. Good to have skills: Stochastic models, Bayesian Models, Markov Chains, Optimization techniques including, Dynamic Programming Deep Learning techniques on structured and unstructured data, Recommender Systems. Proficiency in tools and packages: Python, R(optional), SQL; exposure to dashboard or web-app building using PowerBI, R-Shiny, Flask, open source or proprietary software and packages is an advantage. Knowledge in data standards e. g. OHDSI OMOP, and other data standards, FHIR HL7 for regulatory, and best practices. Good to have: Foundry, big data programming, working knowledge of executing data science on AWS, DataBricks or SnowFlake Strong in Matrix collaboration environments with good communication and collaboration skills with country/ regional/ global stakeholders in an individual contributor capacity. Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. 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:

Clinical Data Associate II 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 Performs data management activities in support of clinical research studies that includes review of clinical data, external vendor supplied clinical data, laboratory data, serious adverse event data, unexpected adverse device events, query management (identification, generation, resolution review and close-out). Primary Responsibilities Track and maintain audit-ready clinical study documentation in support of data and listing reviews within the electronic and/or hard copy Trial Master Files for multiple projects. Perform data entry and query management including data listing review, query creation and resolution. Perform study related activities within budgeted time. Work with QC and QA teams to make the internal TMF ready for study deliverables in regard to data review, reconciliation and listing documentation. Perform study conduct activities including, but not limited to Query Management, Listing Review Perform 3rd party reconciliation and SAE reconciliation as assigned. Adhere to all aspects of SDC s quality system. Comply with SDC s data integrity & business ethics requirements. Perform other duties as assigned. Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements 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 Basic proficiency with Microsoft Word and Excel software Ability to work well in a team environment. Excellent organizational skills and attention to detail Abi

As an RWD SME / RWE Execution Data Scientist, you will focus on executing innovative methodologies and AI models to mine RWD on the data42 platform- You will be the go-to authority for leveraging diverse RWD modalities patterns crucial to understanding patient populations, biomarkers, and drug targets, accelerating the development of life-changing medicines- About the Role Duties and Responsibilities: Collaborate with R&D stakeholders to co-create and implement innovative, repeatable, scaleable and automatable data and technology solutions in line with data42 strategy- Be a data SME, understand RWD of different modalities, vocabularies (LOINC, ICD, HCPCS etc-), non-traditional RWD (Patient reported outcomes, Wearables and Mobile Health Data) and where and how they can be used, including in conjunction with clinical data, omics data, pre-clinical data, and commercial data- Contribute to data strategy implementation such as Federated Learning, tokenization, data quality frameworks, regulatory requirements (submission data to HL7 FHIR formats conversion, Sentinel initiative), conversion to common data models and standards (OMOP, FHIR, SEND etc-), FAIR principles and integration with enterprise catalog Define and execute advanced integrated and scaleable analytical approaches and research methodologies (including industry trends) in support of exploratory and regulatory using AI models for RWD analysis across the Research Development Commercial continuum by facilitating research questions- Stay current with emerging applications and trends, driving the development of advanced analytic capabilities for data42 across the Real-world evidence generation lifecycle, from ideation to study design and execution- Demonstrate high agility working across various cross-located and cross-functional associates across business domains (commercial, Development, Biomedical Research) or Therapeutic area divisions for our priority disease areas to execute complex and critical business problems with quantified business impact/ROI- Draft and edit high-level research documents (proposals, protocols, statistical analysis plans)- [optional] Knowledge of governance, ethical and privacy considerations [optional] Ideal Candidate Profile: PhD or MSc- in a quantitative discipline (e-g-, but not restricted to Computer Science, Physics, Statistics, Epidemiology) with proven expertise in AI/ML- 8+ years of relevant experience in Data Science (or 4+ years post-qualification in case of PhD)- Extensive experience in Statistical and Machine Learning techniques: Regression, Classification, Clustering, Design of Experiments, Monte Carlo Simulations, Statistical Inference, Feature Engineering, Time Series Forecasting, Text Mining, and Natural Language Processing, LLMs, and multi-modal Generative AI- Good to have skills: Stochastic models, Bayesian Models, Markov Chains, Optimization techniques including, Dynamic Programming Deep Learning techniques on structured and unstructured data, Recommender Systems- Proficiency in tools and packages: Python, R(optional), SQL; exposure to dashboard or web-app building using PowerBI, R-Shiny, Flask, open source or proprietary software and packages is an advantage- Knowledge in data standards e-g- OHDSI OMOP, and other data standards, FHIR HL7 for regulatory, and best practices- Good to have: Foundry, big data programming, working knowledge of executing data science on AWS, DataBricks, SnowFlake Strong in Matrix collaboration environments with good communication and collaboration skills with country/ regional/ global stakeholders in an individual contributor capacity- High learning agility and adherence to updates in industry and area of work- Optional Experience in Biomedical Research and development in pharma is a bonus-

The Biostatistician will work with Medical Affairs biostatisticians and Sanofi Global Hub biostatistics and programming personnel to implement statistical analysis plans and provide QC d data packages including tables, figures, and listings for use in publications (i-e- abstracts, posters, oral, presentations, and manuscripts); The Biostatistician will ensure SOPs are followed and timelines and quality metrics are met- People: Develop and maintain effective relationships and collaborations with the end stakeholders (Medical community) and local biostatistics and programming team members within the allocated Global business unit and product with an objective to develop statistical data outputs- Performance / Process: 1) Conduct appropriate post-hoc statistical analyses of clinical trial data- 2) Design, develop, test, implement, and document statistical programming in high-level software packages e-g- SAS- 3) Produce well documented data packages that include tables, listings, and figures- 4) Closely follow QC plans and timelines set by senior members of the Sanofi Global Hub biostatistics and programming team- 5) Review appropriate biomedical and clinical research literature related to assigned project(s)- Customer: Work closely with Global Medical Affairs biostatisticians to identify statistical analysis needs and assist in developing assigned deliverables- About you Experience : Masters degree with 3-6 years (M-Sc-) of experience required /Ph-D- in biostatistics or statistics or epidemiology and 2-3 years- Soft skills : Stakeholder management, Ability to manage timelines and Ability to work independently and within a team environment, High proficiency in statistical methods used in the pharmaceutical industry, Autonomy in the management of activities; ability to manage multiple conflicting high priority deadlines- Technical skills : Advance SAS programming skills, SDTM & ADaM (CDISC) and other statistical computing software skills in a clinical data environment across multiple therapeutic areas- Education : Master of Science degree or equivalent in Statistics/ Ph-D- in biostatistics or statistics or epidemiology- Languages : Excellent English language knowledge written and spoken

Job Title : Senior-Level Data Engineer Healthcare Domain Location: Remote Option Experience: 5+ Years Employment Type: Full-Time About the Role We are looking for a Senior Data Engineer with extensive experience in healthcare data ecosystems and Databricks-based pipelines . The ideal candidate brings deep technical expertise in building large-scale data platforms, optimizing performance, and ensuring compliance with healthcare data standards (e.g., HIPAA, EDI, HCC). This role requires the ability to lead data initiatives, mentor junior engineers, and work cross-functionally with product, analytics, and compliance teams. Key Responsibilities Architect, develop, and manage large-scale, secure, and high-performance data pipelines on Databricks using Spark , Delta Lake , and cloud-native tools . Design and implement healthcare-specific data models to support analytics, AI/ML, and operational reporting. Ingest and transform complex data types such as 837/835 claims , EHR/EMR records , provider/member files , lab results , and clinical notes . Lead data governance, quality, and security initiatives ensuring compliance with HIPAA , HITECH , and organizational policies. Collaborate with cross-functional stakeholders to understand data needs and provide robust, scalable solutions. Mentor junior and mid-level engineers, performing code reviews and technical guidance. Identify performance bottlenecks and implement optimizations in Spark jobs and SQL transformations. Own and evolve best practices for CI/CD , version control, and deployment automation. Stay up to date with industry standards (e.g., FHIR , HL7 , OMOP ) and evaluate new tools/technologies. Required Qualifications 5+ years of experience in data engineering, with 3+ years in healthcare or life sciences domain. Deep expertise with Databricks , Scala , Apache Spark (preferably PySpark) , and Delta Lake . Proficiency in SQL , Python , and data modeling (dimensional/star schema, normalized models). Strong command over 837/835 EDI formats , CPT/ICD-10/DRG/HCC coding , and data regulatory frameworks. Experience with cloud platforms such as Azure , AWS , or GCP and cloud-native data services (e.g., S3, ADLS, Glue, Data Factory). Familiarity with orchestration tools like Airflow , dbt , or Azure Data Factory . Proven ability to work in agile environments , manage stakeholder expectations, and deliver end-to-end data products. Experience implementing monitoring, observability , and alerting for data pipelines. Strong written and verbal communication skills for both technical and non-technical audiences. Education Bachelors degree in Business Administration, Healthcare Informatics, Information Systems, or a related field.

Job Title : Mid-Level Data Engineer Healthcare Domain Location: Remote Option Experience: 2 to 3 Years Employment Type: Full-Time About the Role We are seeking a motivated and detail-oriented Mid-Level Data Engineer with 2 to 3 years of experience in designing, developing, and optimizing data pipelines within the healthcare domain. The ideal candidate will have hands-on experience with Databricks , strong SQL skills, and a solid understanding of healthcare data standards (e.g., HL7, EDI X12 837/835, HCC, CPT/ICD codes). Key Responsibilities Design, develop, and maintain scalable ETL/ELT pipelines using Databricks , PySpark , and Delta Lake for large-scale healthcare datasets. Collaborate with data scientists, analysts, and product managers to understand data requirements and deliver clean, reliable data. Ingest, process, and transform healthcare-related data such as claims (837/835) , EHR/EMR , provider/member , and clinical datasets . Implement data quality checks, validations, and transformations to ensure high data integrity and compliance with healthcare regulations. Optimize data pipeline performance, reliability, and cost in cloud environments (preferably Azure or AWS). Maintain documentation of data sources, data models, and transformations. Support analytics and reporting teams with curated datasets and data marts. Adhere to HIPAA and organizational standards for handling PHI and sensitive data. Assist in troubleshooting data issues and root cause analysis across systems. Required Qualifications 2–3 years of experience in a data engineering role, preferably in the healthcare or healthtech sector. Hands-on experience with Databricks , Apache Spark (PySpark) , and SQL . Familiarity with Delta Lake , data lakes , and modern data architectures . Solid understanding of healthcare data standards : EDI 837/835, CPT, ICD-10, DRG, or HCC. Experience with version control (e.g., Git ), CI/CD workflows, and task orchestration tools (e.g., Airflow , Azure Data Factory , dbt ). Ability to work with both structured and semi-structured data (JSON, Parquet, Avro, etc.). Strong communication skills and ability to collaborate in cross-functional teams. Education Bachelor’s degree in Business Administration, Healthcare Informatics, Information Systems, or a related field.

Provide comprehensive data management expertise to eCOA Data Management to provide efficient, quality data management products that meet customer needs. Provide support in operational eCOA Data Management activities to the eCOA Data Team Lead (DTL) or operate in a specific eCOA DM task (e.g., lead of a task on a megatrial, data reconciliation and monitoring). Essential Functions Serve as Data Operations Coordinator (DOC) for several global clinical trials or serve in a leadership role to a specific data management task. With minimal guidance, serve as back-up for Data Operations Coordinator or Data Team Lead Provide specific eCOA or Clinical DM task or technology expertise. Manage delivery of projects through full data management process life-cycle. With minimal guidance, manage project timelines and quality issues, determine resource needs, and identify and justify out-of-scope. Provide comprehensive data management expertise (including all operations tasks ). Perform comprehensive quality control procedures. Independently bring project solutions to the eCOA DM team. 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 DM and project teams. Interact with eCOA DM team members to negotiate timelines and responsibilities." Qualifications Working knowledge of SAS software a plus, but not required. Bachelors Degree Clinical, biological or mathematical sciences, or related field, or nursing qualification Req 3 years of related experience including clinical trials experience in a function similar to data management. Equivalent combination of education, training and experience. Thorough knowledge of the data management process. Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology. Previous experience and proven competence in managing delivery of project through full data management study life-cycle (of several large phase I or at least 1 medium size Phase III). Comprehensive understanding of clinical drug development process. Excellent organizational, communication, and data management skills (detail oriented). Ability to establish and maintain effective working relationships with coworkers, managers and clients. Thorough knowledge of the data management process. Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology. Previous experience and proven competence in managing delivery of project through full data management study life-cycle (of several large phase I or at least 1 medium size Phase III). Comprehensive understanding of clinical drug development process. Excellent organizational, communication, and data management skills (detail oriented). Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Provide comprehensive data management expertise (defined as efficient and quality data management products) to Data Management (DM) team to meet sponsor and company needs. Perform Clinical Data Management (CDM) Coding activities, and provide leadership either in the role of a Lead Coder or Coding Reviewer or as an individual Subject Matter Expert (SME)or lead a project as Data Operations Coordinator (DOC) or Data Team Lead (DTL)). Essential Functions Serve independently as a Clinical Data Coder, Lead Coder and/or Coding reviewer for one or more projects. Serve as an account lead, or internal or external point of contact on standalone coding studies or accounts. Manage customer relationship for the project team including active participation in coding related customer negotiation on timeline, budgetary and other issues (with guidance). Manage resource capacity for the project team. Manage delivery of coding activities and/or stand-alone coding projects through full study life-cycle. Validates/tests the coding application and programming of coding reports may also test coding related datasets, coding related edits or any coding related programming activities. Perform comprehensive data management and coding related tasks including, conducting data review and writing and resolving data clarifications. Responsible for continuous process improvement and implement process improvement initiatives by working with relevant process experts. Collaborate with customers and develop solutions and action plans for issues, escalations and road blocks. Develop and implement best practices in the team. Manage the development and implementation of new technology. Demonstrate scientific and research temperament by presenting at, or participating in local and international forums. Develop and maintain good communication and working relationship with team , client and other stakeholders. Perform other duties as directed by the study team or Manager, or meet objectives as assigned. Provide review and expert opinion in developing, revising, and maintaining core standard operating procedures and work instructions. Manage coding related project timelines with guidance from the DOC or DTL or Manager. Perform review of coded data ensuring quality and consistency of coding deliverables. Manage project timelines and quality issues and determine coding resource needs. Identify out of scope work. Serve as a back-up for the DOC or DTL or as a DOC or DTL. Perform comprehensive quality control procedures. Perform Serious Adverse Event (SAE) reconciliation activities. Qualifications Pharmacy, dental, medical, nursing, life sciences or related field qualification or educational equivalent 4 years relevant experience including clinical trials experience in a function similar to Data. Management or equivalent combination of education, training and experience. Excellent knowledge of Medical Dictionaries used for coding (e.g. MedDRA, WHODD, ICD9, etc.). Excellent knowledge of Medical Terminology, Pharmacology, Anatomy, and Physiology required for many tasks. Good project management skills related to all phases of clinical studies. Comprehensive knowledge of the data management process from study start-up through to database lock. Knowledge of operating procedures and work instructions and the ability to apply them in practice. Excellent understanding of the Drug Development Process and Data Management s relevance to it. Comprehensive understanding of database technologies related to data management and coding. Excellent organizational, communication and leadership skills. Excellent English written and oral communication skills. Ability to work on computer systems with ease and good working knowledge of computer programs. Ability to exercise excellent attention to detail and act independently with the initiative required to resolve problems. Ability to establish and maintain effective working relationships with co-workers and managers. Understand and interpret financial management concepts. Able to present information effectively to individuals and groups. Able to make independent decisions within scope of authority and considers the impact of decisions on other groups and people. Able to motivate and lead teams to reach defined objectives. Effective team management skills including conflict resolution, delegation, and change management. Excellent interpersonal skills. Able to establish trust and collaborative relationships with customers.

Novo Nordisk Global Business Services (GBS) India Department- Clinical Drug Development (CDD) - Bangalore Global Development Does your motivation come from challenges and working in a dynamic environmentDo you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essentialDo you have a can-do attitude with continuous improvement as one of your career objectivesThen we might have the right position as Statistical Monitor for you. Apply now and join a growing team, working in an international environment. About the department Clinical Data Science, Global Business Services (CDS GBS) was started in September 2007 and within a short span of 16 years since its inception, has transitioned from a small start-up to one of the largest units in GBS and a key contributor to Novo Nordisk clinical development portfolio. As the organisation is growing along with the Research & Development portfolio, we are looking for several new medical Reviewing colleagues. In Clinical Data Science, we are responsible for managing clinical drug development worldwide from early development phases to product introduction. The CMU Bangalore is established in GBS to support the Risk Based Monitoring of clinical trials conducted by Novo Nordisk in line with health authority requirements. The unit is responsible for performance of centralised medical review of patient data that includes medical monitoring and lab surveillance; Statistical Monitoring analysis, and generation of visualisations and reports identifying outliers and trends from various data sources. The Position The Statistical Monitor plays a critical role in supporting Risk-Based Monitoring within Clinical Drug Development by operating and maintaining the centralized Statistical Monitoring function. This position focuses on detecting unusual data patterns, systematic errors, and potential instances of non-compliance or fraud that may not be identified through routine monitoring processes. The Statistical Monitor analyses clinical data across trials and projects to safeguard data integrity, which is essential for the approval of new drug. The role requires a high level of independence, with the potential to mentor junior colleagues and contribute to continuous improvement in data reliability and compliance. Responsible to operate and maintain the Statistical Monitoring function to identify unusual data patterns, systematic errors, and potential protocol non-compliance or fraud across clinical trials and projects. Work closely with trial and project teams, as well as data management and programming experts, to plan and execute statistical monitoring activities according to project timelines. Communicate monitoring observations to relevant stakeholders, support the interpretation of data issues, and contribute to data correction and quality improvement efforts. Contribute to the development, maintenance, and enhancement of statistical monitoring tools and methodologies, including exploring and implementing new techniques. Support training initiatives, participate in meetings and seminars, and foster strong collaboration and knowledge sharing with colleagues and cross-functional teams. Qualifications Holds university degree in life science or engineering (e.g. B.Sc., MSc, MD) or equivalent. 2 years of experience in pharmaceutical industry and preferably 1 year of experience with exploration and/ or visualisation of clinical trial data and scientific data. Experience from clinical development and understanding of data flow. Thorough understanding of clinical research and GCP. Understanding of basic statistical methods, preferably experience from reporting/publishing clinical/scientific data. Good knowledge on computer systems and IT. Exposure with SAS / JMP programming. Worked according to GxP and guidelines within drug development.

Kochi, India| Kolkata, India| Th ne, India| India Job Description Job Overview Provide comprehensive data management expertise (defined as efficient and quality data management products) to Data Management (DM) team to meet sponsor and company needs. Perform Clinical Data Management (CDM) Coding activities, and provide leadership either in the role of a Lead Coder or Coding Reviewer or as an individual Subject Matter Expert (SME)or lead a project as Data Operations Coordinator (DOC) or Data Team Lead (DTL)). Essential Functions Serve independently as a Clinical Data Coder, Lead Coder and/or Coding reviewer for one or more projects. Serve as an account lead, or internal or external point of contact on standalone coding studies or accounts. Manage customer relationship for the project team including active participation in coding related customer negotiation on timeline, budgetary and other issues (with guidance). Manage resource capacity for the project team. Manage delivery of coding activities and/or stand-alone coding projects through full study life-cycle. Validates/tests the coding application and programming of coding reports may also test coding related datasets, coding related edits or any coding related programming activities. Perform comprehensive data management and coding related tasks including, conducting data review and writing and resolving data clarifications. Responsible for continuous process improvement and implement process improvement initiatives by working with relevant process experts. Collaborate with customers and develop solutions and action plans for issues, escalations and road blocks. Develop and implement best practices in the team. Manage the development and implementation of new technology. Demonstrate scientific and research temperament by presenting at, or participating in local and international forums. Develop and maintain good communication and working relationship with team , client and other stakeholders. Perform other duties as directed by the study team or Manager, or meet objectives as assigned. Provide review and expert opinion in developing, revising, and maintaining core standard operating procedures and work instructions. Manage coding related project timelines with guidance from the DOC or DTL or Manager. Perform review of coded data ensuring quality and consistency of coding deliverables. Manage project timelines and quality issues and determine coding resource needs. Identify out of scope work. Serve as a back-up for the DOC or DTL or as a DOC or DTL. Perform comprehensive quality control procedures. Perform Serious Adverse Event (SAE) reconciliation activities. Qualifications Pharmacy, dental, medical, nursing, life sciences or related field qualification or educational equivalent 4 years relevant experience including clinical trials experience in a function similar to Data. Management or equivalent combination of education, training and experience. Excellent knowledge of Medical Dictionaries used for coding (e.g. MedDRA, WHODD, ICD9, etc.). Excellent knowledge of Medical Terminology, Pharmacology, Anatomy, and Physiology required for many tasks. Good project management skills related to all phases of clinical studies. Comprehensive knowledge of the data management process from study start-up through to database lock. Knowledge of operating procedures and work instructions and the ability to apply them in practice. Excellent understanding of the Drug Development Process and Data Management s relevance to it. Comprehensive understanding of database technologies related to data management and coding. Excellent organizational, communication and leadership skills. Excellent English written and oral communication skills. Ability to work on computer systems with ease and good working knowledge of computer programs. Ability to exercise excellent attention to detail and act independently with the initiative required to resolve problems. Ability to establish and maintain effective working relationships with co-workers and managers. Understand and interpret financial management concepts. Able to present information effectively to individuals and groups. Able to make independent decisions within scope of authority and considers the impact of decisions on other groups and people. Able to motivate and lead teams to reach defined objectives. Effective team management skills including conflict resolution, delegation, and change management. Excellent interpersonal skills. Able to establish trust and collaborative relationships with customers. 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 Let s stay connected. Sign up to receive alerts when new opportunities become available that match your career ambitions.

ORGANISATIONAL OVERVIEW JOB DETAILS Department: Clinical Trial Management (CTM) Location: Ahmedabad CTC Range: 3 LPA to 5 LPA Job Description: To assist Project Manager in day to day study related activities. To prepare and maintain required clinical trial tracker for assigned project. To ensure the TMF/E-TMF and Site master files are updated through-out study as per study plan/applicable SOPs. To ensure timely disbursal of Investigator payments based on Invoices received from sites. To assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow. Liaising with other functional groups and providing updates to Project Manager. To act as a central contact for the clinical team for designated project communications, correspondence and associated documentation EXPERIENCE At least 1 years experience in clinical research preferably as CRC EDUCATIONAL QUALIFICATION MSc, M. Pharm, B. Pharm, BAMS, BHMS, Dentist or similar from medical science background. COMPETENCIES Accountability Communication Work Ethic Presentation / Communication skills Organizational Culture fit

Summary Lead scientific engagement with their Medical Experts. Implement clinical and educational strategies and respond to unsolicited medical enquiries. About the Role Job Title: MSL Manager #LI-Onsite Location: Mumbai, India Key Responsibilities Build and maintain scientific relationships with Medical Experts to support strategic engagement. Identify and map key accounts and experts aligned with medical priorities. Develop and execute engagement plans tailored to country-specific strategies. Respond to unsolicited medical inquiries with accurate, up-to-date scientific information. Support clinical trial execution and site education in collaboration with clinical operations. Facilitate Investigator Initiated Trial (IIT) processes upon investigator request. Act as a scientific resource for internal field teams and cross-functional partners. Ensure timely reporting of adverse events and technical product complaints. Essential Requirements Proven experience in operations management and cross-functional collaboration. Strong understanding of clinical research and medical affairs processes. Proficiency in scientific communication, including medical writing and data interpretation. Familiarity with CRM tools and digital platforms for stakeholder engagement. Knowledge of disease management, drug development, and epidemiology. Ability to analyze and present clinical data effectively. Fluency in English, both written and spoken. Desirable Requirements Prior experience in a Medical Scientific Liaison or similar field-based medical role. Advanced degree in life sciences (e.g., MD, PhD, PharmD) preferred.

Summary To manage and complete assigned Medical Communications deliverables at high quality standards and in accordance with agreed timelines. Projects include manuscripts, abstracts, posters, slide sets, satellite symposia content, congress or advisory board reports, publication planning and medical education materials for internal medical and/or clinical teams. About the Role Location Hyderabad #LI Hybrid Major Responsibilities: Demonstrate a command of assigned therapeutic areas and expertise with assigned products. Research and write original content for publications activities (primary and review manuscripts, abstracts, posters), slide presentations and other materials based on direction and materials supplied by customers. Prepare meeting materials for satellite symposia (agenda, slide content, speaker briefings etc), and reports from advisory boards and other internal or external meetings. Develop content that is scientifically accurate, evidence-based, grammatically accurate, referenced using appropriate sources, and consistent with quality standards for author review, customer review as appropriate, and scientific peer review. As needed, perform quality control (QC) checking / proof reading of the above-mentioned documents to meet customer expectations. Clearly communicate medical scientific concepts in a condensed, audience-appropriate way. Follow all internal processes and procedures with regard to workflow, development of deliverables, and adherence to industry best practices, including GPP3. Demonstrate the flexibility/adaptability necessary to function on different therapeutic teams as needed and to work on projects across multiple brands at any given time. Interpret and apply clinical data in medical communication deliverables. Work in conjunction with service team and line manager to develop and adhere to logical and attainable timelines for project completion. Provide input and aid in troubleshooting / problem-solving. Collate and incorporate author/customers comments. Lead and/or participate in author/client teleconferences. Provide accurate citations in text (utilizing Reference Manager system), a bibliography, and appropriately annotated references for medical review. Participate in strategic and tactical publications planning and related research. Work as part of a team; train new colleagues as and when required. Supports people and performance management. Maintains records for all assigned projects including archiving. Maintains audit, SOP and training compliance. Performs additional tasks as assigned. Minimum Requirements: Education: Minimum: Minimum science degree or equivalent. Desirable: MSc, PhD, PharmD, or MD. Work Experience: Minimum of 5 years experience in medical communications. Medical writing experience. Good understanding of industry work processes for publications. Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook). Why Novartis: Our purpose is to reimagine medicine to improve and extend people s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve thisWith our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https: / / www.novartis.com / about / strategy / people-and-culture You ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. Commitment to Diversity and Inclusion: 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. Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

Senior Medical Writer (CSR, IB , Protocol) Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives we re able to create a place where everyone feels like they belong. Job Responsibilities Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately Manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision Complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings Adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides Coordinate quality and editorial reviews, ensuring source documentation is managed appropriately Act as a peer reviewer for the internal team to ensure document scientific content, clarity, overall consistency, and proper format Review statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency, providing feedback to further define statistical output required and document needs Interact and build good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables Perform online clinical literature searches and comply with copyright requirements Identify and propose solutions to resolve issues, providing technical support, training, and consultation to department and other company staff Mentor and lead less experienced medical writers on complex projects Develop deep expertise on key topics in the industry and regulatory requirements Work within budget specifications for assigned projects Qualifications: Bachelors degree in a relevant discipline with relevant writing experience; graduate degree preferred 5 years of relevant experience in science, technical, or medical writing Experience working in the biopharmaceutical, device, or contract research organization industry required Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required Experience writing relevant document types required Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style Necessary Skills: Strong presentation, proofreading, collaborative, and interpersonal skills Strong project and time management skills Strong proficiency in MS Office Strong understanding of medical terminology, principles of clinical research, and how to interpret and present clinical data and other complex information

Biostatistician II statistical analyses for clinical research studies as outlined in statistical analysis plans, including creating statistical graphics and verifying randomization codes. They prepare statistical sections of protocols, including sample size calculations, annotate shell data displays, and provide specifications for the structure, content, and algorithms of status and analysis datasets. They perform and oversee quality control (QC) of data displays with inferential statistics. Statisticians report to the Biostatistics Manager. QUALIFICATIONS FOR ESSENTIAL FUNCTIONS Develop, validate, and maintain SAS programs to create analysis datasets, tables, listings, and figures (TLFs) as specified in statistical analysis plans. Design and verify randomization codes to support clinical trial integrity. Prepare statistical sections of protocols, including sample size calculations, and annotate shell data displays. Provide specifications for the structure, content, and algorithms of status and analysis datasets. Perform and oversee quality control (QC) of data displays and analysis datasets to ensure accuracy and compliance with CDISC standards (SDTM, ADaM). Conduct independent validation of datasets created by other programmers or statisticians. Maintain project administration files, including protocols, annotated CRFs, statistical analysis plans, and programming/QC documentation. Manage electronic project directories to ensure organization and accessibility of deliverables. Mentor and guide junior programmers, providing training on SAS programming and clinical data standard Works in the area of Software Engineering, which encompasses the development, maintenance and optimization of software solutions/applications.1. Applies scientific methods to analyse and solve software engineering problems.2. He/she is responsible for the development and application of software engineering practice and knowledge, in research, design, development and maintenance.3. His/her work requires the exercise of original thought and judgement and the ability to supervise the technical and administrative work of other software engineers.4. The software engineer builds skills and expertise of his/her software engineering discipline to reach standard software engineer skills expectations for the applicable role, as defined in Professional Communities.5. The software engineer collaborates and acts as team player with other software engineers and stakeholders.

Ensure production & accuracy targets are met as per client expectation Daily learning & updating of changes in client protocols Utilize the AI tools effectively & process is efficient & effective Daily annotation records Required Candidate profile 1 to 3yrs of Exp in nursing/ hospital/ annotation environment is an added advantage Strong verbal &written communication skill in English Strong comprehension & analytical skills

Looking for Trainer Who Provides Offline training on Clinical Data Management On Part time basis Provides training and monitors performance to ensure the team are operating at the highest level to design and deploy clinical databases. Required Candidate profile Should have Experience on clinical data management Entire Work Process EDC SAE Reconciliation. should have Experience on Softwares (Oracle Inform/ Mediidata Rave) Interested Contact - 9133469786

About the job An exciting opportunity to join our risk-based monitoring team. Risk-based monitoring (RBM) is an adaptive approach to clinical trial monitoring that directs focus and activities to critical data and processes that have the most potential to impact patient safety and data quality. In this context, the RBM team is responsible for designing, executing, and optimizing the Sanofi RBM approach to align with regulatory requirements and Sanofis objective to drive quality, efficiency, and speed of clinical trials. The Clinical Data Curator Specialist (CDCS) is responsible for the maintaining, organizing and improving the accessibility of clinical data to support Advance Analytics having expertise in Data Manipulation, Data extraction, Data Optimization, Data Visualization etc. Understanding of AI fundamentals with knowledge of Machine learning. This role will involve working closely with a group of core Data Scientists to ensure accuracy, completeness, and relevance of the data that will used for analysis. If you are passionate about leveraging data to drive excellence in clinical trials, this is the opportunity for you. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people s lives. We re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started Main responsibilities: Data Inventory and Organization : Maintain a comprehensive inventory of clinical data sets to ensure clear structure and long-term usability. Implement best practices for data organization and governance. Collaborative Problem Solving : Work closely with data scientists to understand data requirement and quality standards, collaborate with digital to enhance and optimize the data pipelines and integration processes. Data Extraction and Curation : Extract, curate, and prepare clinical data sets to ensure they are fit for purpose and adhere to data governance standards. Enhance data quality for use in advanced analytics. AI/Machine Learning : Hands on experience in Machine Learning and its application in clinical trials to derive meaningful insights from data. Risk Based Quality Assurance : Implement and continuously improve a risk-based quality assurance process. Ensure proper documentation of datasets used for analysis to safeguard data integrity and ensure reliable results. Develop code/workflows and optimise existing ones : Leverage domain expertise and technical knowledge to continually enhance existing code and develop new one as per changing requirements. About you Experience : Experience in a Clinical Research environment (CRO or Pharma). In depth knowledge of clinical data programming using SAS - Base, Macros, SQL/ Python/R and experienced in handling data from multiple data sources. Soft and technical skills : Learns and adapt quickly when facing new problems. Think critically and use rigorous, objective and pragmatic methods to solve multidimensional problems with effective and timely solutions. Strong analytical skills with the ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy Proficiency in programming languages (either SQL, Python, Advance SAS or R). A professional certification will be a nice to have. Hands on experience in data wrangling, data extraction and manipulation from diverse input data sources using advance SQL concepts. In depth knowledge of optimizing queries and joins to efficiently process large datasets of varying degree of complexity. Familiarity with machine learning (using Python packages) and their application in clinical trial In depth understanding of clinical trial related documents and clinical knowledge, e.g., Protocol, SDS, CRF and the ability to churn both structured and unstructured data to generate meaningful output. Strong analytical skills with an attention to detail. Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams. Education : Bachelor s degree or above, preferably in a life science or mathematics-related area (e.g., computer sciences) Languages : Strong English skills (verbal and written), ability to exchange fluently in a global environment. 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 and at least 14 weeks gender-neutral parental leave. An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team A team that driving the innovation of the monitoring activities that align with future need We believe that a Clinical Data Curator is not only collects data for storage, but you are key to brining data to life in an AI-driven world; its a role that embodies innovation, curiosity, and the power to transform data into actionable insights. Join us as a curator of our AI future, supported by cutting-edge technology and a collaborative team environment. Better is out there. Better medications, better outcomes, better science. But progress doesn t happen without people people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let s be those people.

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.