652 Clinical Trials Jobs - Page 7

Qualifications required: M Pharm/ PharmD ONLY FOR MALE Candidates. NOTE: Only Male & Candidates from AP & Telangana Preferred. Salary- 2.2LPA (14k+ Inhand Salary 2Years Bond & Need to Submit your 10th Original Mark list with us during the Bond Period. Job description: 1. Providing inputs for the study design based on literature and prior experience. 2. Providing inputs for the preparation of protocol summaries and study protocols. 3. Plan PK analysis and concentration data checking before PK analysis. 4. Perform PK analysis using WinNonlin and applicable softwares. 5. Preparing and / or Reviewing the Protocols and Clinical study reports if required on need basis. 6. Provide justifications and responses for regulatory queries. Perform study and Pharmacokinetic investigations.

We are looking for an Assistant Manager- Regulatory Affairs and Pharmacovigilance for a Global Pharmaceutical MNC based in BKC, Mumbai Position: Assistant Manager- Regulatory Affairs (Domestic market) Experience: 7+ in Regulatory affairs for domestic market Location: BKC, Mumbai Purpose of the Role: Ensure the highest professional standards in Regulatory Affairs and Pharmacovigilance to align with business objectives, values, and regulatory compliance. Key Responsibilities: Maintain and upload data to Health Authority databases (e.g., SUGAM, FDA). Compile and submit applications for product registration (drugs, medical devices, food supplements). Handle CMC (Chemistry, Manufacturing, and Controls) queries and lifecycle management, including labeling, license renewals, and artwork reviews. Develop and implement regulatory strategies for export markets and ensure compliance with CDSCO and international regulations. Support inspections, audits, and internal Quality Management Systems (QMS). Manage product complaints, recalls, and suspected falsified products. Maintain global and local regulatory databases. Profile Requirements: Qualifications: B.Pharm/M.Sc. with 78 years of experience; MBBS/M.Pharm/Ph.D. (preferred). Skills: Strong understanding of CMC, non-clinical, and clinical data; proficiency in MS Office; excellent communication and organizational skills. Competencies: Knowledge of regulatory requirements, drug development, risk-benefit analysis, adaptability, and teaching ability. Key Attributes: Professional discretion, ability to work independently, attention to detail, and enthusiasm for maintaining high standards in regulatory and pharmacovigilance activities.

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Job Purpose: Provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed products Signal detection/analysis/evaluation and ongoing safety surveillance activities Provide medical guidance and input to Drug Safety associates (DSAs) and specialists in medical aspects of drug safety Function as pharmacovigilance representative/safety scientist General Maintaining a good working knowledge of the Adverse event profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and international drug safety regulations Maintaining an awareness of global regulatory requirements and reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting Maintaining excellent knowledge of the safety profile of assigned products Communicating and discussing issues related to review process with Project Manager Interacting with internal and external contacts for resolving issues Maintaining a good working knowledge of relevant regulatory guidelines Attend and present client/cross functional meetings along with other stakeholders Case report Medical review Performing medical review of cases according to client Standard Operating Procedures (SOPs) and liaising with the client, as required Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality Assessing seriousness and expectedness of reported events Providing medical advice to case processing team Skills: Excellent interpersonal, verbal and written communication skills Computer proficiency, an ability to work with web-based applications and familiarity with the Windows operating system Client focused approach to work A flexible attitude with respect to work assignments and new learnings Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Ability to assess the clinical relevance of medical data and to interpret its clinical meaning is essential Willingness to work in a matrix environment and to value the importance of teamwork Strong knowledge of international drug regulation including GCP, GVP Knowledge and Experience : Good knowledge of medical terminology. Fresher/ relevant experience into pharmacovigilance/ Drug Safety field is preferred. Education: MBBS/MD

Study Designer and Edit Check Programmer We are looking for a talented individual to join us as a Study Designer and Edit Check Programmer, reporting directly to the Sr. Manager, Clinical Systems and Analytical Reporting. The successful candidate will play a crucial role in adhering to Amgen standards, procedures, and best practices to build and program studies in our clinical trial database. This position will require effective partnership with other CSAR Operations and cross-functional staff to ensure seamless, high-quality deliverables and activities related to the use of electronic data capture (EDC) technology. We are seeking a strong leader who can confidently influence stakeholders and contribute individually to study-specific and general CSAR/GDO projects or operational work. The ideal candidate will have proven experience in partnering effectively with cross-functional teams to deliver systems support and study deliverables. Additionally, they should have operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC). Responsibilities include, but are not limited to: Support of clinical trial platform technologies Support decision-making by acting as a data scientist, bringing awareness to patterns and analytical insight Coordinating and providing programming support to Clinical Study Teams Ensure efficient and consistent use of EDC systems and compliance with established procedures/standards Acting as a technical point of contact for systems deliverables on defined programs Identify, recommend, or implement system enhancements, new tools, or emerging technologies to reduce database development cycle time and foster a collaborative working environment Providing technical and business process input/expertise on new and emerging technologies Develop, review, and implement policies, SOPs, and associated documents Ensure documentation supports CSAR operational or technical activities in a complete manner, consistent with regulatory and established processes Assist in preparing for and responding to audit findings (internal or external) Knowledge Areas: Good Clinical Practice Strong understanding and experience in performance management techniques, measures, problem-solving, and analytical thinking Drug development and clinical trials processes Data management processes Clinical trial databases and applications Edit check development and custom function programming Programming languages Systems development lifecycle (SDLC) Project planning and management Collaborating with global cross-functional teams (team/matrix environment) Quality management and risk analysis Regulatory filings and inspections Process improvement methodologies Preferred Qualifications: Advanced degree or equivalent in life science, computer science, math, statistics, business administration, or related discipline Broad knowledge/work experience in data management/programming in the pharmaceutical or biotech sector General project management and planning experience Experience in oversight of external vendors (CROs, central labs, imaging vendors, IRT vendors, etc.) Basic Qualifications: Bachelor's degree or equivalent in life science, computer science, business administration, or related discipline with 9 to 12 years of experience Specialist knowledge/experience in life sciences or a medically related field General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical, or CRO company)

SUMMARY SAR & SAR-like Patient Safety Physician Job Description Responsible for compiling PBRERs with a focus on medical aspects and safety sections of products, and analyzing safety trends, including source data analysis based on queries Assisting in identifying, analyzing, and drawing conclusions from safety data for cumulative trends Collaborating with Therapeutic Head to identify signals and address product safety concerns Engaging with Therapeutic Area colleagues for enhanced understanding and development Measurable Goals Ensuring 100% compliance with timely completion of all client and Cognizant required trainings Achieving 100% compliance with work allocation plan, including case closure based on agreed timelines and quality benchmarks Non - Measurable Attributes Self - motivated Goal-oriented Interdepartmental collaboration Personal grooming and etiquette Punctuality Team player and process-oriented Competencies Proficient in delivering presentations Effective at collaborating across different cultures Strong preference for structured and process-driven tasks Committed to completing training and documentation on time Experience Relevant educational background and experience in patient safety or related field Required Skills Strong presentation and communication skills Effective intercultural work capabilities Commitment to timely completion of tasks and documentation Analytical and problem-solving skills Collaboration and teamwork abilities Requirements Requirements: Relevant educational background and experience in patient safety or related field Strong presentation and communication skills Effective intercultural work capabilities Commitment to timely completion of tasks and documentation Analytical and problem-solving skills Collaboration and teamwork abilities

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.

Role & responsibilities : Collaborating with cross-functional teams (e.g., clinical researchers, medical experts, data scientists) to design clinical studies and research protocols. Developing statistical analysis plans (SAP), including the identification of primary and secondary endpoints, sample size calculations, and statistical methodologies. Ensuring statistical methods are aligned with regulatory requirements and industry standards, especially in clinical trials. Providing expertise on randomization techniques and adaptive designs. Leading the analysis of complex datasets, including data from clinical trials, epidemiological studies, and observational studies. Ensuring proper data cleaning, transformation, and validation processes are followed to guarantee the integrity of the data. Using advanced statistical software and techniques (e.g., R, SAS, STATA) to perform statistical modeling (e.g., regression models, survival analysis, mixed models). Analyzing and interpreting results, ensuring conclusions are scientifically sound, and communicating findings in a clear, concise manner. Developing and applying advanced statistical methodologies and techniques tailored to specific study needs, such as longitudinal analysis, survival analysis, or Bayesian methods. Assessing and adapting statistical methods as necessary based on emerging data or evolving study designs. Participating in regulatory meetings and discussions, providing statistical justification for study results and approaches. Mentoring and providing guidance to junior biostatisticians and other team members on statistical methodologies, software, and best practices. Developing training materials and conducting workshops on statistical topics for internal teams and collaborators. Ensuring statistical methods and processes are consistent with industry best practices and organizational standards. Conducting quality control procedures on statistical analyses to verify results and ensure accuracy and validity. Preparing statistical reports, manuscripts, presentations, and posters for scientific journals, conferences, and internal stakeholders. Clearly presenting complex statistical results to non-statistical audiences (e.g., clinical or regulatory teams), ensuring the results are understood and actionable. Working closely with other teams, including clinical researchers, project managers, and data scientists, to ensure the alignment of statistical analyses with research objectives. Actively participating in meetings, strategy sessions, and research reviews to provide statistical insights that can influence study direction and design. Translating statistical findings into actionable recommendations for decision-making. Ensuring that statistical analyses comply with ethical standards and regulatory requirements (e.g., Good Clinical Practice (GCP), Good Statistical Practice (GSP)). Supporting the development of ethical guidelines for statistical methodologies, including ensuring patient safety and data confidentiality. Additional Skills: SAS Programming R Programming (Optional) Advanced knowledge of biostatistics, including statistical theory, methods, and applications. Proficiency in statistical software such as SAS, R, and STATA. Strong communication skills, especially in translating complex statistical concepts into practical recommendations. Attention to detail and the ability to ensure the quality and accuracy of analyses. Experience with clinical trials and regulatory submissions is often critical Qualifications: Master's Degree (Preferred): A Master's in Biostatistics, Statistics, Public Health, or a related field is commonly required for many biostatistician roles, especially in CRO, research institutions, pharmaceutical companies, or public health organizations

Job Description: The Analytics Associate Consultant will be responsible for making objective customer-focused, research and data-driven decisions by providing analytical insight, actionable data, and recommendations. You would also be responsible for projects, providing analytics support, and serving in a consultative capacity to deliver value-added descriptive analytics solutions to our clients. What your day would look like: Brainstorming with onshore team and end clients to understand business requirements and provide solutions for complex client specifications Execute and manage ad-hoc research requests such as disease burden analysis, market assessment/landscape, competitive analysis, product and company profiling, industry analysis, KOL mapping, clinical trials analysis (drug development phases, trial design and mechanism of actions, primary & secondary end point analysis) Develop broad knowledge of pharmaceutical market through project delivery and participation in formal learning opportunities Designing methodology and solutions for key business asks Advanced analysis using large volume of sales and patient level datasets Use of excel, PowerPoint, IQVIA Data Assets to derive and represent actionable insights Act as an advocate for client needs, putting yourself in their shoes to ideate on ways to enhance business value for the client What s in it for you: Impacting change at scale for leading global pharma clients Working on exciting new ways of deriving insights from large data sets with an industry leader in the pharma domain Working in a highly dynamic environment with exposure to learning across analytics domains and technology (including AI/ML) Autonomy and ownership of your workstream and engagement including a chance to lead your own team/(s) Opportunity to grow project and accounts by building new tools/service lines/capabilities by working with senior leaders globally Significant opportunities to grow as a part of a global analytics organization Opportunity to travel internationally on an as needed basis What we re looking for: Total experience: 2 - 5 years for Associate Consultants Experience working in analytics projects deriving actionable insights based on desk research and implementing them Deep knowledge of desk research methodologies in the pharma context i.e., sources for prevalence, incidence, drug pipelines, identifying pharma marketing initiatives (digital/DRC), assessing investor reports and formulary guidelines Creative and business focused approach, with experience in thinking through the lens of end client objectives Articulate communicator handling challenging situations with structured thinking and solution minded focus. Leading communication with internal and external stakeholders with minimal supervision Proactive in identifying potential risks and implementing mitigation strategies to avoid potential issues downstream Collaborate closely with onshore teams to understand business context and deliver client-ready materials Should have an intermediate MS Excel and strong PowerPoint knowledge Synthesize and document results using PowerPoint slides Ability to Story Board is a preferred (Presenting your analysis insights in the form of presentation with meaningful insights for the stakeholders) Ability to learn quickly in a dynamic environment Provide thought leadership and innovation Previous experience of working in a global environment will be advantageous

Summary -Responsible for the drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs. Participates in the resolution of any legal liability and complying with governmental regulations. Provides and contributes trending and safety signal detection and risk management assessment for the products life cycle. Provides safety support to the clinical development teams. About the Role Major accountabilities: Monitors the clinical safety of projects /products including activities such as literature review, evaluation of individual cases or signal detection, and responds to safety related questions appropriately . Performs medical assessment and related activities for cases whenever required, including collecting additional follow-up information as necessary, medical evaluation of product quality defects with adverse events, review of line listings of single cases, and preparation of investigator notifications and periodic medical assessments for ethics committees. Identifies safety signals based on the review of solicited or unsolicited single cases. Performs signal detection, monitoring and evaluation of all safety signals. Provides inputs into responses to inquiries from regulatory authorities or health care professionals on safety issues. Prepares safety data for Health Authority review boards. Provides inputs to responses for legal queries and Country Organization requests involving safety issues. Provides expert evaluation on the clinical context of adverse event reports, assessment of the medical conditions, and the implications on Novartis products. Collaborates productively on clinical safety tasks with colleagues from Clinical Development, Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology and other related departments. Contributes to the development of departmental goals and objectives. Distribution of marketing samples (where applicable) Key performance indicators: Timeliness and quality of safety analyses, interpretations, and presentations -Compliance with internal and external regulations and procedures -Compliance, consistency and quality of safety deliverables Minimum Requirements: Work Experience: People Challenges. Critical Negotiations. People Leadership. Collaborating across boundaries. Operations Management and Execution. Skills: Clinical Trials. Functional Teams. Literature Review. Management Skills. Medical Information. Medical Records. Medical Strategy. Pharmacovigilance. Regulatory Compliance. Risk Management. Safety Science. Languages : English. 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:

Are you looking for a meaningful and fulfilling career in Project Management within the Clinical Research industry? Join Clarios Medical Imaging team in Bengaluru, India, and be part of a legacy with over 30 years of expertise. We specialize in providing seamless, secure, and compliant medical imaging solutions that enhance clinical trials. At Clario, we have ambitious goals and a clear vision for the future. This is your chance to be part of our journey as an Assistant Clinical Project Manager. What we offer Competitive compensation Attractive benefits (security, flexibility, support and well-being) Engaging employee programs Technology for hybrid working and great onsite facilities What youll be doing Assists Clinical Project Managers with project administration by: Developing project related documents Reviewing and editing project presentations Participating in project meetings, conference calls, and training calls Reading and understanding project protocol documents Acting as a liaison with cross-functional team members to ensure timely completion of all study deliverables. Reporting study needs and issues Supporting overall project start-up, execution and close out activities Supporting project finance-related activities such as: Assistance with documentation / database updates due to project scope changes Follow-up related to invoice reconciliations. Preparation of project reports in support of project forecasting activities Assists Clinical Project Managers in maintaining, reviewing, and communicating project progress by: Monitoring internal data flow to ensure completion of tasks within agreed upon timeframes Responding to inquiries in a professional, courteous, and timely manner Communicating with clients regarding project status Verifying protocol imaging requirements are met and queries appropriately identified Serving as acting Project Manager in the absence of the assigned Project Manager Creating, reviewing, and distributing (internally and/or externally) project report(s) Ensures the development and adherence to project timelines by: Following up on outstanding items including missing data, incomplete paperwork, queries, etc. Assisting in tracking and resolving of client issues Serving as additional point of contact to client, sites, sponsors, etc. Supporting Logistics with the distribution, management and tracking of site-facing materials Keeping clinical project manager(s) (CPM) and supervisor advised of current issues Maintains Quality Service and Departmental Standards by Reading, understanding, and adhering to organizational Standard Operating Procedures (SOPs) Executing technical and clinical functions as required by the study protocol in accordance with Clario s GCP s, ICH and FDA Guidelines. Reviewing and providing recommendations to management on operational procedures, and by participating in process improvement initiatives. What we look for Bachelor s Degree preferred 1 + years of experience working in pharmaceutical drug development, clinical trials, and/or clinical research preferred Strong experience with and knowledge of the Microsoft Office suite of software productivity tools Healthcare, medical experience, and/or clinical research, preferred Strong organizational, interpersonal, time management, and prioritization skills Excellent interpersonal, verbal and written communication skills, including ability to communicate effectively in English Detail oriented, meticulous, and responsive to inquiries and requests Ability to work independently, and to collaborate in a team setting Ability to deal with uncertainty, and adapt to changing priorities Pragmatic, proactive and goal oriented Ability to project and maintain a professional and positive attitude. .

Safety Scientist We are currently seeking a Safety Scientist to join our diverse and dynamic team. As a Safety Scientist at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of inNvative treatments and therapies. What you will be doing Conducting safety surveillance activities for assigned projects, including the review and interpretation of safety data. Partnership with cross-functional teams to ensure the safety of study participants and compliance with regulatory requirements. Contributing to the development and implementation of safety management plans and risk minimization strategies. Participating in safety review meetings and providing expert input on safety-related matters. Contributing to the preparation of safety-related documents for regulatory submissions and responses to regulatory queries. Oversees operational activities as the functional PV team lead. Assist project teams in client meetings when pharmacovigilance, safety surveillance, risk management which require expert knowledge beyond the expertise of Drug Safety Associates are discussed Support literature search and review projects by: Authoring literature search and review plans for routine pharmacovigilance, local literature, aggregate safety analysis, EMA Medical Literature Monitoring Defining search parameters (string terms) Conducting literature search and review as per project-specific plan Under the Guidance of a Director, Pharmacovigilance specialized services and/or Senior Principal/ Principal safety scientist, the safety scientist is responsible for: Aggregate safety report generation Coordinate aggregate safety report generation, including data collection, data and document querying, coordination of internal and external reviews, and interfacing with the Client and Safety Writers. Generate and maintain aggregate safety report plans including generation of data specifications and literature search requirements. Author where necessary or review aggregate safety report drafts, including Sponsor authored drafts where ICON is legal representative Safety surveillance activities Coordinate and document the signal detection strategy Draft required plans and forms Manage and organize the source data Participate in development and generation of the data assessment visuals and tables in ICON visualization tool. Review interval and cumulative data as per safety surveillance plan Document and track all signal management activities Generate and / or Review signal detection reports, signal validation reports and signal assessment reports Organizes and coordinates internal and external meetings regarding signal management, including drafting of minutes Draft safety section of product reference documents (e.g. IB/ reference safety information, CCDS/CCSI, local labeling). Review of safety sections of a protocol, Review safety listings, review of ICSRs Generation of development risk management plans (dRMP), risk management plans (RMP), and risk evaluation and mitigation strategies (REMS) Coordinate risk management document generation, including data collection, data and document querying, coordination of internal and external reviews, and interfacing with the Client and Safety Writers. Track initial RMP filing and subsequent updates Support risk management SMEs on appropriate strategy and design of risk management activities and risk minimization measures. Perform implementation, tracking and communication of risk management commitments including risk minimization measures Contribute to generation and maintenance of: Pharmacovigilance system master files (PSMF) and associated project plans. Pharmacovigilance agreements and associated project plans Other activities: - Assist with the maintenance of key performance indicators (KPIs) and compliance metrics. - Assist in preparation of audits and inspections. - Participate in ICON initiatives for the implementation and integration of new or enhanced: - Process development or maintenance (SOPs, WPs, templates, best practices) - Systems, databases and tools - Development and/or delivery of training courses on pharmacovigilance related topics to ICON Your profile Bachelors degree in life sciences, pharmacy, or related field; advanced degree preferred. Solid experience in pharmacovigilance or drug safety within the pharmaceutical or clinical research industry. Strong understanding of pharmacovigilance principles, regulations, and guidelines. Excellent analytical and critical thinking skills, with the ability to interpret complex medical data. Effective communication skills, with the ability to cooperate effectively with cross-functional teams. Detail-oriented and able to work effectively in a fast-paced environment with changing priorities.

Informed Consent Specialist II - Office or Home - India Were currently seeking an Informed Consent Form (ICF) Specialist to join our diverse and dynamic team. As an ICF Specialist at ICON, youll be crucial in ensuring the accuracy, compliance, and timely approval of informed consent forms for clinical trials. Your role will directly contribute to the ethical conduct of clinical research and the successful initiation of studies. What youll be doing: Developing and reviewing ICFs: Preparing, reviewing, and approving Subject Information Sheets (SIS) and Informed Consent Forms (ICF) for global master templates, country-specific versions, and site-specific adaptations. Ensuring compliance: Applying proficient knowledge of ICON SOPs/WPs, ICH/GCP guidelines, and applicable country regulations related to Informed Consent requirements. Stakeholder collaboration: Serving as a key point of contact for Sponsors, SSU Project Managers, Clinical Trial Managers, and other functional leads to optimize performance and ensure successful project outcomes. Query resolution: Proficiently reviewing, negotiating, and approving all Ethics Committee (EC), Institutional Review Board (IRB), and Competent Authority (CA) queries related to country and site-specific ICFs. Timeline management: Forecasting and tracking SIS & ICF approval timelines, proactively identifying risks, and developing contingency plans to mitigate potential impacts. Knowledge leadership: Acting as a Subject Matter Expert (SME) for assigned topics, staying updated on changing regulatory and language requirements affecting ICFs, and developing/conducting training. Documentation and archiving: Ensuring the accuracy and completeness of ICF documents transferred for filing into the Trial Master File (TMF). Mentorship: Mentoring and coaching new hires during their onboarding process. Representing FSA: Representing the department at audits, inspections, and on various committees and work groups. Your profile: Minimum 2 years of experience in ICF writing/development. Strong English writing and and communication skills are required. Proficient knowledge of ICH/GCP guidelines and applicable country regulations related to Informed Consent. Ability to work collaboratively in a team environment and effectively communicate with diverse stakeholders. Strong analytical and problem-solving skills, with excellent attention to detail. Protocol interpreting & review is preferred, but not required. #LI-KT1 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

Job Description: The Analytics Associate Consultant will be responsible for making objective customer-focused, research and data-driven decisions by providing analytical insight, actionable data, and recommendations. You would also be responsible for projects, providing analytics support, and serving in a consultative capacity to deliver value-added descriptive analytics solutions to our clients. What your day would look like: Brainstorming with onshore team and end clients to understand business requirements and provide solutions for complex client specifications Execute and manage ad-hoc research requests such as disease burden analysis, market assessment/landscape, competitive analysis, product and company profiling, industry analysis, KOL mapping, clinical trials analysis (drug development phases, trial design and mechanism of actions, primary & secondary end point analysis) Develop broad knowledge of pharmaceutical market through project delivery and participation in formal learning opportunities Designing methodology and solutions for key business asks Advanced analysis using large volume of sales and patient level datasets Use of excel, PowerPoint, IQVIA Data Assets to derive and represent actionable insights Act as an advocate for client needs, putting yourself in their shoes to ideate on ways to enhance business value for the client What s in it for you: Impacting change at scale for leading global pharma clients Working on exciting new ways of deriving insights from large data sets with an industry leader in the pharma domain Working in a highly dynamic environment with exposure to learning across analytics domains and technology (including AI/ML) Autonomy and ownership of your workstream and engagement including a chance to lead your own team/(s) Opportunity to grow project and accounts by building new tools/service lines/capabilities by working with senior leaders globally Significant opportunities to grow as a part of a global analytics organization Opportunity to travel internationally on an as needed basis What we re looking for: Total experience: 2 - 5 years for Associate Consultants Experience working in analytics projects deriving actionable insights based on desk research and implementing them Deep knowledge of desk research methodologies in the pharma context i.e., sources for prevalence, incidence, drug pipelines, identifying pharma marketing initiatives (digital/DRC), assessing investor reports and formulary guidelines Creative and business focused approach, with experience in thinking through the lens of end client objectives Articulate communicator handling challenging situations with structured thinking and solution minded focus. Leading communication with internal and external stakeholders with minimal supervision Proactive in identifying potential risks and implementing mitigation strategies to avoid potential issues downstream Collaborate closely with onshore teams to understand business context and deliver client-ready materials Should have an intermediate MS Excel and strong PowerPoint knowledge Synthesize and document results using PowerPoint slides Ability to Story Board is a preferred (Presenting your analysis insights in the form of presentation with meaningful insights for the stakeholders) Ability to learn quickly in a dynamic environment Provide thought leadership and innovation Previous experience of working in a global environment will be advantageous . 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

Informed Consent Specialist II - Office or Home - India 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 Were currently seeking an Informed Consent Form (ICF) Specialist to join our diverse and dynamic team. As an ICF Specialist at ICON, youll be crucial in ensuring the accuracy, compliance, and timely approval of informed consent forms for clinical trials. Your role will directly contribute to the ethical conduct of clinical research and the successful initiation of studies. What youll be doing: Developing and reviewing ICFs: Preparing, reviewing, and approving Subject Information Sheets (SIS) and Informed Consent Forms (ICF) for global master templates, country-specific versions, and site-specific adaptations. Ensuring compliance: Applying proficient knowledge of ICON SOPs/WPs, ICH/GCP guidelines, and applicable country regulations related to Informed Consent requirements. Stakeholder collaboration: Serving as a key point of contact for Sponsors, SSU Project Managers, Clinical Trial Managers, and other functional leads to optimize performance and ensure successful project outcomes. Query resolution: Proficiently reviewing, negotiating, and approving all Ethics Committee (EC), Institutional Review Board (IRB), and Competent Authority (CA) queries related to country and site-specific ICFs. Timeline management: Forecasting and tracking SIS & ICF approval timelines, proactively identifying risks, and developing contingency plans to mitigate potential impacts. Knowledge leadership: Acting as a Subject Matter Expert (SME) for assigned topics, staying updated on changing regulatory and language requirements affecting ICFs, and developing/conducting training. Documentation and archiving: Ensuring the accuracy and completeness of ICF documents transferred for filing into the Trial Master File (TMF). Mentorship: Mentoring and coaching new hires during their onboarding process. Representing FSA: Representing the department at audits, inspections, and on various committees and work groups. Your profile: Minimum 2 years of experience in ICF writing/development. Strong English writing and and communication skills are required. Proficient knowledge of ICH/GCP guidelines and applicable country regulations related to Informed Consent. Ability to work collaboratively in a team environment and effectively communicate with diverse stakeholders. Strong analytical and problem-solving skills, with excellent attention to detail. Protocol interpreting & review is preferred, but not required.

Job Description Java Technical Lead About ArisGlobal: (www.arisglobal.com): ArisGlobal is empowering life science organizations to deliver breakthroughs faster, accurately, and with precision. This is paramount for the passage of lifesaving medications and products VIA clinical trials, using our software and technology. As an industry leader, ArisGlobal provides our SaaS leading technology and services to 40/50 top Bio-pharmaceutical corporations, 4/5 of the most advanced global pharmaceutical companies and nine government-health authorities, including the FDA, Health Canada and the NMPA, for example, around the world. 2021 has presented simultaneous developments in the global Drug Safety and Pharmacovigilance Software Market, projecting unfaltering growth through 2027. Effectively harnessed by prominent market drivers, ArisGlobal is named a Key Player. Located in Miami, New Jersey, Budapest, Dublin, Darmstadt, Rome, Tokyo, Shanghai, Bangalore, Mysore, our global presence is clear, and we are growing faster than ever. Skills & Experience Required: Candidate should have 4 to 6 Years of hands-on Java Programming experience Should have experience in Java, J2EE, Spring, Hibernate, SQL/MySQL & Microservices Minimum 2+ Years of hands-on experience in React Js (Mandatory) Should have worked on Apache Kafka, Mongo DB & AWS Should have experience in Leading/Mentoring team Key Responsibilities : Execute the design, analysis, or evaluation of assigned projects using sound engineering principles and adhering to business standards, practices, procedures, and product / program requirements Design & code a variety of complex software features with adequate documentation Customer Support & troubleshoot/fix a variety of difficult software problems. Proactively communicate on development status & delays in agreed upon timelines Interface with global teams for requirements analysis and schedule.

Safety Scientist 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 We are currently seeking a Safety Scientist to join our diverse and dynamic team. As a Safety Scientist at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of inNvative treatments and therapies. What you will be doing Conducting safety surveillance activities for assigned projects, including the review and interpretation of safety data. Partnership with cross-functional teams to ensure the safety of study participants and compliance with regulatory requirements. Contributing to the development and implementation of safety management plans and risk minimization strategies. Participating in safety review meetings and providing expert input on safety-related matters. Contributing to the preparation of safety-related documents for regulatory submissions and responses to regulatory queries. Oversees operational activities as the functional PV team lead. Assist project teams in client meetings when pharmacovigilance, safety surveillance, risk management which require expert knowledge beyond the expertise of Drug Safety Associates are discussed Support literature search and review projects by: Authoring literature search and review plans for routine pharmacovigilance, local literature, aggregate safety analysis, EMA Medical Literature Monitoring Defining search parameters (string terms) Conducting literature search and review as per project-specific plan Under the Guidance of a Director, Pharmacovigilance specialized services and/or Senior Principal/ Principal safety scientist, the safety scientist is responsible for: Aggregate safety report generation Coordinate aggregate safety report generation, including data collection, data and document querying, coordination of internal and external reviews, and interfacing with the Client and Safety Writers. Generate and maintain aggregate safety report plans including generation of data specifications and literature search requirements. Author where necessary or review aggregate safety report drafts, including Sponsor authored drafts where ICON is legal representative Safety surveillance activities Coordinate and document the signal detection strategy Draft required plans and forms Manage and organize the source data Participate in development and generation of the data assessment visuals and tables in ICON visualization tool. Review interval and cumulative data as per safety surveillance plan Document and track all signal management activities Generate and / or Review signal detection reports, signal validation reports and signal assessment reports Organizes and coordinates internal and external meetings regarding signal management, including drafting of minutes Draft safety section of product reference documents (e.g. IB/ reference safety information, CCDS/CCSI, local labeling). Review of safety sections of a protocol, Review safety listings, review of ICSRs Generation of development risk management plans (dRMP), risk management plans (RMP), and risk evaluation and mitigation strategies (REMS) Coordinate risk management document generation, including data collection, data and document querying, coordination of internal and external reviews, and interfacing with the Client and Safety Writers. Track initial RMP filing and subsequent updates Support risk management SMEs on appropriate strategy and design of risk management activities and risk minimization measures. Perform implementation, tracking and communication of risk management commitments including risk minimization measures Contribute to generation and maintenance of: Pharmacovigilance system master files (PSMF) and associated project plans. Pharmacovigilance agreements and associated project plans Other activities: - Assist with the maintenance of key performance indicators (KPIs) and compliance metrics. - Assist in preparation of audits and inspections. - Participate in ICON initiatives for the implementation and integration of new or enhanced: - Process development or maintenance (SOPs, WPs, templates, best practices) - Systems, databases and tools - Development and/or delivery of training courses on pharmacovigilance related topics to ICON Your profile Bachelors degree in life sciences, pharmacy, or related field; advanced degree preferred. Solid experience in pharmacovigilance or drug safety within the pharmaceutical or clinical research industry. Strong understanding of pharmacovigilance principles, regulations, and guidelines. Excellent analytical and critical thinking skills, with the ability to interpret complex medical data. Effective communication skills, with the ability to cooperate effectively with cross-functional teams. Detail-oriented and able to work effectively in a fast-paced environment with changing priorities.

Position Summary This role will be responsible for in-patient journey analysis and working with patient-level data to develop a robust solution for the client's teams. An expert in Patient Analytics who can guide and lead the team supporting pharma clients Job Responsibilities Effectively manage the client/ onshore stakeholders, as per the business needs, to ensure successful business delivery. Work closely with the project manager to define the algorithm, break down the problem into execution steps, and run the analysis Ensure high-quality analytics solutions/reports to the client Delivery role will include project scoping, solution design, execution, and communication of the analysis in the client-ready formats Contribute towards Axtria tools and capabilities as per the business requirements. Build organization capabilities by participating in Hackathon, solution design, and process automation Effectively communicate with onshore/ client (as per business needs) Education Bachelor of Engineering in Statistics Work Experience Behavioural Competencies Teamwork & Leadership Motivation to Learn and Grow Ownership Cultural Fit Project Management Communication Technical Competencies Python R SQL EXCEL MMx Forecasting Machine Learning Pharma Commercial Know How HEOR EPI and Economic Analysis HEOR Simulation Analysis Patient Data Analytics Know How Dataiku KNIME Others

Career Category Information Systems Job Description Role Description: You will play a key role in the implementation and adoption of the data governance framework which will modernize Amgens data ecosystem, positioning Amgen as a leader in biopharma innovation. This role leverages state-of-the-art technologies, including Generative AI, Machine Learning, and integrated data. You will leverage domain, technical and business process expertise to provide exceptional support of Amgen s data governance framework. This role involves working closely with business stakeholders and data analysts to ensure implementation and adoption of the data governance framework. You will collaborate with the Product Owner and other Business Analysts to ensure operational support and excellence from the team. Roles Responsibilities: Responsible for the data governance and data management framework implementation for a given domain of expertise (Research, Development, Supply Chain, etc. ). Responsible for the operationalization of the Enterprise data governance framework and aligning broader stakeholder community with their data governance needs, including data quality, data access controls, compliance with privacy and security regulations, foundational master data management, data sharing, communication and change management. Works with Enterprise MDM and Reference Data to enforce standards and data reusability. Drives cross functional alignment in his/her domain(s) of expertise to ensure adherence to Data Governance principles. Create and maintain privacy policies and procedures to protect sensitive data and ensure compliance. Conduct regular privacy risk assessments and audits to identify and mitigate potential risks as required Maintain documentation on data definitions, data standards, data flows, legacy data structures / hierarchies, common data models, data harmonization etc. for assigned domains. Ensure compliance requirements with data privacy, security, and regulatory policies for the assigned domains including GDPR, CCPA, and other relevant legislations. Jointly with Technology teams, business functions, and enterprise teams (e. g. , MDM, Enterprise Data Fabric, etc. ) define the specifications shaping the development and implementation of data foundations . Build strong relationships with key business leads and partners to ensure their needs are being met Functional Skills: Must-Have Functional Skills: Technical skills with knowledge of Pharma processes with specialization in a domain (e. g. , Research, Clinical Trials, Commercial, etc. ) In depth knowledge of data management, common data models, metadata management, data quality, master data management, data stewardship, data protection, etc. Strong understanding of data protection laws and regulations, including GDPR, CCPA, and other relevant legislations. In depth experience with data products development life cycle, including the enablement of data dictionaries, business glossary to increase data products reusability and data literacy. Customer-focused with excellent written and verbal communication skills who can confidently work with internal Amgen business stakeholders and external service partners on business process and technology topics In depth experience of working with or supporting systems used to data governance framework. E. g. Collibra, Alation Excellent problem-solving skills and committed attention to detail in finding solutions Good-to-Have Functional Skills: Experience of working with data governance councils or forums Experience with Agile software development methodologies (Scrum) Proficiency in data analysis and quality tools (e. g. , SQL, Excel, Python, or SAS) 3-5 years of experience in data privacy, compliance, or a related field. Soft Skills: Integrity: Commitment to maintaining the highest ethical standards and protecting confidential information. Adaptability: Ability to adapt to changing regulations and emerging privacy challenges. Proactivity: Self-motivated with a proactive approach to identifying and addressing privacy issues. Leadership: Strong leadership skills and the ability to influence and drive change within the organization. Highly organized and able to work under minimal supervision Excellent analytical and assessment skills Ability to work effectively with global, virtual teams Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Ambitious to further develop their skills and career Ability to build business relationships and understand end-to-end data use and needs. Excellent interpersonal skills (team player). People management skills either in matrix or direct line function. Strong verbal and written communication skills High degree of initiative and self-motivation. Good presentation and public speaking skills. Strong attention to detail, quality, time management and customer focus. Basic Qualifications: Any Degree and 9-13 years of experience .

Career Category Information Systems Job Description Role Description: You will play a key role in the implementation and adoption of the data governance framework which will modernize Amgens data ecosystem, positioning Amgen as a leader in biopharma innovation. This role leverages state-of-the-art technologies, including Generative AI, Machine Learning, and integrated data. You will leverage domain, technical and business process expertise to provide exceptional support of Amgen s data governance framework. This role involves working closely with business stakeholders and data analysts to ensure implementation and adoption of the data governance framework. You will collaborate with the Product Owner and other Business Analysts to ensure operational support and excellence from the team. Roles Responsibilities: Responsible for the data governance and data management framework implementation for a given domain of expertise (Research, Development, Supply Chain, etc. ). Responsible for the operationalization of the Enterprise data governance framework and aligning broader stakeholder community with their data governance needs, including data quality, data access controls, compliance with privacy and security regulations, foundational master data management, data sharing, communication and change management. Works with Enterprise MDM and Reference Data to enforce standards and data reusability. Drives cross functional alignment in his/her domain(s) of expertise to ensure adherence to Data Governance principles. Develop and implement data quality frameworks. Design and enforce standards for data quality and governance to ensure consistent, accurate, and reliable data. Maintain documentation on data definitions, data standards, data flows, legacy data structures / hierarchies, common data models, data harmonization etc. data quality best practices and tools for assigned domains. Ensure compliance requirements with data privacy, security, and regulatory policies for the assigned domains. Collaborate with stakeholders and work closely with data stewards, analysts, IT, and business units to understand data requirements and address quality concerns. Jointly with Technology teams, business functions, and enterprise teams (e. g. , MDM, Enterprise Data Fabric, etc. ) define the specifications shaping the development and implementation of data foundations . Build strong relationships with key business leaders and partners to ensure their needs are being met. Lead data quality initiatives aimed at improving data quality, including data cleansing, enrichment, and validation processes. Functional Skills: Must-Have Functional Skills: Technical skills with knowledge of Pharma processes with specialization in a domain (e. g. , Research, Clinical Trials, Commercial, etc. ). In depth knowledge of data management, common data models, metadata management, data quality, master data management, data stewardship, data protection, etc. In depth experience with data products development life cycle, including the enablement of data dictionaries, business glossary to increase data products reusability and data literacy. Customer-focused with excellent written and verbal communication skills who can confidently work with internal Amgen business stakeholders and external service partners on business process and technology topics In depth experience of working with or supporting systems used to data governance framework. E. g. Collibra, Alation Excellent problem-solving skills and committed attention to detail in finding solutions. Proficiency in data analysis and quality tools (e. g. , SQL, Excel, Python, or SAS) Good-to-Have Functional Skills: Experience of working with data governance councils or forums Experience with Agile software development methodologies (Scrum) 3-5 years of experience in data quality management, data governance, or related roles. Soft Skills: Highly organized and able to work under minimal supervision Excellent analytical and assessment skills Ability to work effectively with global, virtual teams Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Ambitious to further develop their skills and career Ability to build business relationships and understand end-to-end data use and needs. Excellent interpersonal skills (team player). People management skills either in matrix or direct line function. Strong verbal and written communication skills High degree of initiative and self-motivation. Good presentation and public speaking skills. Strong attention to detail, quality, time management and customer focus. Basic Qualifications: Any Degree and 9-13 years of experience .

Job Description: Accountable for the medical review of relevant clinical, other solicited and spontaneous cases (including literature articles), medical assessment (including labeling and causality along with the company causality statement) Review the medical sense including seriousness and coding of the case in the global context of the drug or clinical project, including the narrative, AE/SAE terms, suspect drugs, concomitant medications, laboratory data, and medical history Developing and maintaining thorough knowledge of the appropriate disease biology areas & important safety concerns for marketed drugs and drugs in development Assuring and maintaining compliance with regulatory and local/global SOP timelines Supporting the Drug Safety teams with medical concepts and awareness of product related topics to ensure quality of adverse event data processing Representing safety physician team in internal and client safety forums and audits Review and respond to any queries/comments for an individual case safety report in the Patient Safety database. Responsible for generating, sending, and tracking medically relevant queries for follow-up information that is required for an individual case safety report Provide product advice as required, especially with regards to case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR) Ensure compliance with global and local procedural documents and implementation of client and , policies, procedures, and processes. Skills required: Computer Literate (e.g., knowledge of MS Office) Aptitude for self-directed learning Good medical knowledge and its application in drug safety

We are seeking a highly motivated and detail-oriented Research Ops Intern- Clinical Data to join our dynamic team. The ideal candidate will have a strong background in oncology, the ability to understand and interpret medical terminology from Electronic Health Records (EHR) and medical reports, and the expertise to extract and analyze data from patient notes. The candidate must have a background of clinical research and is able to comprehend clinical trials. Also have good knowledge about patient pre-screening, enrolling participants in oncology clinical trials . The role requires proficiency in Google Sheets and Excel, along with the ability to correlate medical data to meet specific requirements. Duration: 3 months Key Responsibilities: Clinical Trials Acumen: Interpret the Inclusion and Exclusion criteria outlined in the clinical trials on clinicaltrials.gov and in study protocols, and use this information to assess patient eligibility for clinical trials. Data Extraction and Curation: Extract relevant data from patient notes, EHRs, patient information, medical history, laboratory/pathology results, diagnoses, and treatments, to support oncology research and clinical decision-making. Medical Terminology: Interpret and understand complex medical terms, especially those related to oncology to ensure accurate data extraction and analysis. Data Management: Maintain and manage datasets using Google Sheets and Excel, ensuring data accuracy and integrity. Correlation and Interpretation: Analyze medical data to identify patterns and correlations that align with project requirements. Quality Assurance: Conduct regular quality checks and validation of extracted data to ensure consistency and accuracy. Patients Pre-screening: Knowledge of pre-screening patients before enrolling to clinical trials would be required to curate and verify clinical trials on the companys platform Qualifications: Bachelors/Masters degree in a relevant field such as Clinical Research, Health Information Management, Medical Informatics, Oncology, or a related discipline. 6 months of experience in clinical research/oncology research/ clinical data abstraction/ clinical data curation. Candidates with Clinical Trial Certification will be preferred. Proficiency in Google Sheets and Excel; familiarity with data extraction tools and EHR systems. Strong understanding of oncology, medical, and pathology terminologies. Excellent analytical and problem-solving abilities, with a keen eye for detail. Strong written and verbal communication skills, with the ability to present complex data in a clear and concise manner. Ability to manage multiple tasks and projects simultaneously, with strong organizational and time-management skills. Ability to work effectively both independently and as part of a multidisciplinary team.

We are seeking a highly motivated and detail-oriented Research Ops Intern- Clinical Data to join our dynamic team. The ideal candidate will have a strong background in oncology, the ability to understand and interpret medical terminology from Electronic Health Records (EHR) and medical reports, and the expertise to extract and analyze data from patient notes. The candidate must have a background of clinical research and is able to comprehend clinical trials. Also have good knowledge about patient pre-screening, enrolling participants in oncology clinical trials . The role requires proficiency in Google Sheets and Excel, along with the ability to correlate medical data to meet specific requirements. Duration: 3 months Key Responsibilities: Clinical Trials Acumen: Interpret the Inclusion and Exclusion criteria outlined in the clinical trials on clinicaltrials.gov and in study protocols, and use this information to assess patient eligibility for clinical trials. Data Extraction and Curation: Extract relevant data from patient notes, EHRs, patient information, medical history, laboratory/pathology results, diagnoses, and treatments, to support oncology research and clinical decision-making. Medical Terminology: Interpret and understand complex medical terms, especially those related to oncology to ensure accurate data extraction and analysis. Data Management: Maintain and manage datasets using Google Sheets and Excel, ensuring data accuracy and integrity. Correlation and Interpretation: Analyze medical data to identify patterns and correlations that align with project requirements. Quality Assurance: Conduct regular quality checks and validation of extracted data to ensure consistency and accuracy. Patients Pre-screening: Knowledge of pre-screening patients before enrolling to clinical trials would be required to curate and verify clinical trials on the companys platform Qualifications: Bachelors/Masters degree in a relevant field such as Clinical Research, Health Information Management, Medical Informatics, Oncology, or a related discipline. 6 months of experience in clinical research/oncology research/ clinical data abstraction/ clinical data curation. Candidates with Clinical Trial Certification will be preferred. Proficiency in Google Sheets and Excel; familiarity with data extraction tools and EHR systems. Strong understanding of oncology, medical, and pathology terminologies. Excellent analytical and problem-solving abilities, with a keen eye for detail. Strong written and verbal communication skills, with the ability to present complex data in a clear and concise manner. Ability to manage multiple tasks and projects simultaneously, with strong organizational and time-management skills. Ability to work effectively both independently and as part of a multidisciplinary team.

We are seeking a highly motivated and detail-oriented Research Ops Intern- Clinical Data to join our dynamic team. The ideal candidate will have a strong background in oncology, the ability to understand and interpret medical terminology from Electronic Health Records (EHR) and medical reports, and the expertise to extract and analyze data from patient notes. The candidate must have a background of clinical research and is able to comprehend clinical trials. Also have good knowledge about patient pre-screening, enrolling participants in oncology clinical trials . The role requires proficiency in Google Sheets and Excel, along with the ability to correlate medical data to meet specific requirements. Duration: 3 months Key Responsibilities: Clinical Trials Acumen: Interpret the Inclusion and Exclusion criteria outlined in the clinical trials on clinicaltrials.gov and in study protocols, and use this information to assess patient eligibility for clinical trials. Data Extraction and Curation: Extract relevant data from patient notes, EHRs, patient information, medical history, laboratory/pathology results, diagnoses, and treatments, to support oncology research and clinical decision-making. Medical Terminology: Interpret and understand complex medical terms, especially those related to oncology to ensure accurate data extraction and analysis. Data Management: Maintain and manage datasets using Google Sheets and Excel, ensuring data accuracy and integrity. Correlation and Interpretation: Analyze medical data to identify patterns and correlations that align with project requirements. Quality Assurance: Conduct regular quality checks and validation of extracted data to ensure consistency and accuracy. Patients Pre-screening: Knowledge of pre-screening patients before enrolling to clinical trials would be required to curate and verify clinical trials on the companys platform Qualifications: Bachelors/Masters degree in a relevant field such as Clinical Research, Health Information Management, Medical Informatics, Oncology, or a related discipline. 6 months of experience in clinical research/oncology research/ clinical data abstraction/ clinical data curation. Candidates with Clinical Trial Certification will be preferred. Proficiency in Google Sheets and Excel; familiarity with data extraction tools and EHR systems. Strong understanding of oncology, medical, and pathology terminologies. Excellent analytical and problem-solving abilities, with a keen eye for detail. Strong written and verbal communication skills, with the ability to present complex data in a clear and concise manner. Ability to manage multiple tasks and projects simultaneously, with strong organizational and time-management skills. Ability to work effectively both independently and as part of a multidisciplinary team. Locations : Mumbai, Delhi / NCR, Bengaluru , Kolkata, Chennai, Hyderabad, Ahmedabad, Pune, India.

IDEAL DELIGHT SERVICES is looking for CRO Specialist to join our dynamic team and embark on a rewarding career journey Analyze website and marketing funnel performance data to identify areas for improvement and conversion opportunities. Design, implement, and manage A/B and multivariate tests to optimize key performance indicators such as click-through rates, bounce rates, and conversion rates. Collaborate with UX/UI designers, developers, and marketing teams to implement CRO strategies that enhance user experience and drive results. Use analytics tools (e.g., Google Analytics, Hotjar, Optimizely) to gather behavioral insights and generate actionable recommendations. Develop hypotheses for testing and create detailed documentation and reporting to track test outcomes and insights. Continuously monitor performance metrics and make data-driven recommendations to improve the conversion funnel. Stay informed on industry best practices, emerging trends, and tools in CRO and digital marketing.

Role & responsibilities 1. Development and review of clinical documents including protocol, investigator's brochure, case record form, product rationale, prescribing information, drug interactions and clinical study reports etc 2. Prepare CSRs revisions, IB updates, protocols, protocol amendments etc 3. Development and review of medical rationale for CT waiver applications 4. Support SEC meetings for clinical trials and marketing approvals by preparation of presentations & literature search 5. Work with the study biostatistician to engage early with the study team including participation in the review of mock and/or blinded tables, figures, and listings (TFLs), and narrative planning for relevant documents 6. Works closely with the study team to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other information sources. 7. Works closely with the study team to reach consensus on timelines for deliverables 8. Completes documents according to agreed-upon timelines and follows up with the study team as needed to meet internal and external timeline commitments, and to ensure SOP and regulatory compliance 9. Schedules and conducts document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes 10. Ensuring that the content, format and structure of clinical documents comply with regulatory, journal, or other guidelines 11. Reviewing and proofreading materials to check quality and scientific accuracy 12. Ensures documents are generated in accordance with agreed internal processes and standards, are submission ready, and are appropriately stored in agreed document management system 13. Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables, responds to findings, and recommends quality process improvements. Additional responsibilities 1. Development and review of clinical and non-clinical overviews and summaries of CTD 2. Development and review of marketing requests of product evaluations, comparative safety and efficacy evaluations 3. Develop manuscripts, abstracts, and PowerPoint slide decks based on in-house studies and to support marketing team. 4. Mentoring/ training team members to gain required skills to enable on-time deliverables 5. Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed 6. Understands the functions and roles within the study team and aligns with them in delivery of documents to meet project-related goals and to meet external results disclosure obligations