174 Clinical Development Jobs

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 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 Training and mentoring new team member, as required Working as Subject Matter Experts (SMEs) Assisting the Manager for inspection readiness activities and audits Provides inputs for process improvisations Works closely with Manger for process co-ordination and to ensure meeting all KPIs for the process. Case report Medical review (as applicable) 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 DSPs and 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: Relevant experience of minimum 2 Years in Pharmacovigilance/ drug safety is desirable. Education: MBBS/Post Graduation in Medicine.

Study Start Up Specialist POSITION PURPOSE: Study Start Up Specialist is responsible for country study start up (SSU) activities and performing quality review of essential documents. The SSU Specialist is responsible for overseeing and leading SSU activities in collaboration with country team members (CLM and CRA) with the objective to improve site activation and maximize patient recruitment time. The SSU Specialist is responsible for the start-up of clinical trial activities in their assigned country/countries to achieve greenlight for selected sites. Specialist also performs quality review of essential documents at start up and during the lifecycle of the study, ensuring adherence to ICH-GCP guidelines, local requirements and Bayer QSDs. ROLE AND RESPONSIBILITIES: Interact with site and study personnel to collect country specific documents such as IRB/IEC approvals, financial disclosure, CVs/medical licenses, etc. and review for accuracy, completeness and adherence to ICH/GCP and Bayer QSDs Perform quality review of country and site level essential documents following a risk-based approach, issue queries, and communicate outcome to identified users at key milestones and during the course of the study Prepare and submit regulatory and IRB/IEC documentation as required per country requirements and Bayer QSDs during the course of the study Preparation, tracking, and distribution of site start up documentation including Investigator Site File Obtain any required approvals for relevant site document (e.g. informed consent, financial disclosures) to ensure start up timelines are met Manage oversight, in collaboration with CLM, of country and site start up activities and eTMF quality using Vault Clinical reports and dashboards Monitor internal start up KPIs across studies and identify and communicate trends Support start up process improvement implementation In collaboration with CRA, maintain and ensure accuracy of site information in Vault Assist with audits/inspections of relevant start up activities and/or eTMF Attend and actively participate in team meetings by providing site greenlight projections and timelines Provide input on site activation strategy Ensure awareness of related local regulations and support maintenance of country intelligence in Veeva WHO YOU ARE: The incumbent should have a Bachelor s degree (or equivalent experience) and minimum of 2 years of experience in clinical development including start up/ regulatory process experience Understanding of ICH-GCP essential documentation and familiarity with country specific clinical trial regulations Demonstrated ability to quality review documents and identify discrepancies/inconsistencies preferred Ability to embrace Veeva Clinical Vault system and associated functionality Strong written and verbal English communication skills Flexibility to adapt to changing business needs and priorities Demonstrated organization skills and attention to detail Strong service orientation Ability to work independently and manage multiple tasks and priorities Ever feel burnt out by bureaucracy? Us too. That s why we re changing the way we work for higher productivity, faster innovation, and better results. We call it Dynamic Shared Ownership (DSO). Learn more about what DSO will mean for you in your new role here Bayer does not charge any fees whatsoever for recruitment process. Please do not entertain such demand for payment by any individuals / entities in connection with recruitment with any Bayer Group entity(ies) worldwide under any pretext. Please don t rely upon any unsolicited email from email addresses not ending with domain name bayer.com or job advertisements referring you to an email address that does not end with bayer.com . Bayer is an equal opportunity employer that strongly values fairness and respect at work. We welcome applications from all individuals, regardless of race, religion, gender, age, physical characteristics, disability, sexual orientation etc.

Summary -Provide expert support and functional and technical knowledge to ensure the scientific integrity/validity for clinical development, early development, and/or research projects. Participate in the full lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. Provide statistical support for regulatory submissions including planning, analysis and reporting of clinical safety and efficacy summaries. May also provide statistical support to research or other R&D areas. -Responsible for advising/leading the planning, development & implementation of Industry (CDISC and regulatory) compliant, high quality, clinical data standards, infrastructure or automation technologies. Providing expert support and stellar customer focus to business users and teams on their use, including: -Data standard collection tools in EDC (CRFs, edits checks, derivations, core configurations) -Data transfer specifications -Analysis data/TFL standards/Define -Automation solutions / technologies -Business infrastructure, business rules and guidelines. About the Role Major accountabilities: Drive the implementation of data analytics reports and dashboards for optimal data review by working with the users to establish robust user specifications and with programmers to implement the optimal output -Translate business requirements into logical models and provide direction to the development team to translate business logic. Lead authoring of the user requirements document, functional specifications and functional testing scripts -Proactively identify or address needs for optimal data review working with users and programmers as appropriate. Implement and execute robust project plans for delivery, ensuring customer needs are addressed in a timely manner. Provide coordination between the project resources so that deadlines are met on deliverables. Drive development of appropriate user training. Drive all necessary change management activities related to implementation of new data review tools / reports as related to data cleaning, review and visualization. Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Key performance indicators: Timely execution of of projects & data requests -Feedback from project sponsors and key stakeholders -Adherence to Novartis policy and guidelines -Metrics and Adherence to KPIs Minimum Requirements: Work Experience: Functional Breadth. Cross Cultural Experience. Managing Crises. Collaborating across boundaries. Operations Management and Execution. Skills: Automation. Biostatistics. Clinical Trials. Computer Programming. Metadata Management. Statistical Analysis. Languages : English. Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

At Quanticate, were pioneers in providing top-tier statistical and data management support to our clients. Were seeking a dedicated "Clinical Data Manager I" whos committed to upholding the highest standards, following procedures, and ensuring compliance with regulations, all while providing exceptional customer care. As a "Clinical Data Manager I" you will lead, co-ordinate, and action all tasks relating to Clinical Data Management from the start to the finish of a study to project manage studies across CDM functions. Core Accountabilities: Activities required of a Clinical Data Manager I (however not restricted to) are as below: To contribute to the efficient running of the CDM department as part of the CDM leadership team. Ensure launch, delivery, and completion of all CDM procedures according to contractual agreement and relevant SOPs, guidelines, and regulations To pro-actively keep abreast of current clinical data management developments and systems To assist in the creation and review of in-house SOPs. To research and provide input into in-house strategies and systems. To perform medical coding activities on projects, if assigned. To perform other reasonable tasks as requested by management. Ensure consistency of process and quality across projects. Project management for allocated projects: To help plan and manage study timelines and resources. To manage progress against schedules and report to management. To perform project management across all functions for a study as appropriate. Management of CRFs and all related tasks Management of allocated staff: Allocation of projects in conjunction with Project Management, as appropriate Performance reviews, as required. Administer training and development of staff, as required. Key Relationships: Act as the primary CDM contact, both external and internal, for Quanticate projects. Manage work assignment and delivery of project tasks to the data processing and programming team as required Line management responsibilities for any assigned direct reports, including professional development/training and performance appraisals. Qualified to an appropriate standard, preferably to degree level in a life sciences subject Four to seven years of relevant experience in CRO Clinical Data Management domain. Extensive knowledge of

Job Description Literature search and patent review of products Responsible for formulation development of DPI, SMI pMDIs formulations for US, EU, ROW, CSI and IRF markets. Responsible for planning and execution of development- Pilot / Scale-up and Exhibit activities for pulmonary formulations. Responsible for preparation of timelines, costings for ongoing projects. Responsible for preparation and compilation of project related documents in compliance with quality and regulatory requirements. Responsible for lab maintenance and upkeep of the laboratory and equipment s Responsible for analytical data and interpretation for way forward Responsible for procurement and control of innovators samples and maintaining their records. Responsible for Coordination with planning, engineering department and purchase department for product related activities Responsible for Preparation of department SOPs, guidelines, product related protocols and tech transfer documents along with DQA, CQA and regulatory team. To provide timely support for cross functional activities like regulatory queries, clinical development, technical support to manufacturing plants and intellectual property related inputs and feedback. To provide support for launching and troubleshooting of approved products. Work Experience 12 years + Education Masters in Pharmacy or Pharmacy Doctorate in Pharmacy or Pharmacy Competencies

QC and formatting of clinical trial protocols, informed consent forms (ICFs), clinical study reports (CSRs), investigator’s brochures (IBs), and clinical data summaries for phase 1-phase 3 and post-marketing surveillance studies and as per agreed timelines. QC and formatting of clinical modules of eCTD dossiers for global approval in developed and emerging markets with high quality and as per agreed timelines. Ad-hoc writing support for clinical documents such a ICFs, CSRs and protocols CSR publishing for regulatory submissions. Ad hoc QC and formatting support for cross-functional teams in Medical Affairs and Clinical Development Support in creating and/or updating SOPs, checklists, and templates. Work collaboratively with other medical writers and cross-functional stakeholders within the Clinical Development function. Support Group Lead in maintaining and tracking medical writer occupancy and resourcing Qualification M Pharm with minimum 5 years of experience in document QC and formatting within the pharmaceutical industry Excellent written, spoken, interpersonal and presentation skills Proficiency in editing and formatting documents using Microsoft Office and Acrobat. Good understanding of medical terms, clinical trials, and drug development process. Ability to analyze and interpret scientific and medical data Highly detailed orientated and excellent time management skills Additional Information About the Department Biologics Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 10–15-year time horizon. With a robust portfolio of biosimilar products across key therapeutic areas, covering ~US$80+ Bn in innovator sales – future business pipeline covers a variety of product classes and therapy areas, and new modalities. Fully integrated organization with over two decades of experience in developing, manufacturing and commercializing multiple biosimilar products. With a Product Development engine that has end-to-end capabilities – in-house clone development, upstream and downstream process development, bioanalytical development and proprietary formulation. Supported by a Clinical and Regulatory team with experience in executing complex biosimilar programs with innovative global trial designs. We have a proven experience in commercial-scale manufacturing across a variety of technology platforms with global quality standards and a highly competitive cost structure Rich experience of commercializing high-quality biosimilars in multiple markets with over 900,000 patients having benefited from our products till date. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/

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

Title: Lead - Regulatory Writing Date: 10 Jun 2025 Location: Bangalore, KA, IN EDUCATION: MBBS/PhD/MDS/BDS/MPharm/PharmD EXPERIENCE: 4 to 6 years experience in writing Clinical & Regulatory documents supporting global filings (CTD Module 2 and Module 5) ROLE PURPOSE: Lead Medical Writer is responsible for the development and review of medical writing deliverables that support the clinical regulatory writing portfolio and train the junior writers. SKILLS: Experience in authoring a broad set of different clinical document types that support regulatory filings with a preference for experience with Module 2.3, 2.4, 2.5, 2.7, 5.2, clinical study reports (CSRs,) protocols, Informed Consent Forms, amendments, and Investigator Brochures (IBs) Demonstrated excellence in focused/lean writing and editing following defined processes and templates Lead cross-functional teams to draft agreed-upon scientific/ medical content that addresses data interpretation, product claims, and internal/external questions Understanding of clinical development process from program panning to submission, including clinical trial design Communication skills commensurate with a professional working environment Effective time management, organizational, and interpersonal skills Customer focus Comfortable following directions, templates, and structured processes for delivering documents for review and finalization Able to work independently while maintaining communication with the Sponsor s MW project manager Ability to move across Therapeutic Areas to support business continuity and resource needs Ability to develop, coordinate, and oversee work plans for both individual and multiple-document delivery, with all the needed tasks and subtasks, timelines, and assigned roles and responsibilities that enable the team to work efficiently and effectively to deliver all milestone tasks and documents within specified timelines Develop work plan and ensure adherence Ability to manage the tasks, roles, responsibilities, and timing of the authoring team, internal/external contributors, and reviewers to facilitate document completion Adherence to processes and Sponsor-defined best practices Ability to facilitate review meetings, address feedback, and negotiate solutions/agreements KNOWLEDGE REQUIREMENT: Scientific Knowledge Strong knowledge of regulatory guidelines/requirements and other regional guidelines such as those from the European Union and the United States Ability to interpret data and apply scientific knowledge to support regulatory document writing (ie. IB, protocols, amendments, CSR, Clinical summaries) Ability to build clinical or regulatory arguments in the absence of direct data using logic, analogy and therapeutic area science Understanding of medical practices regarding procedures, medications, and treatment for different disease states Manage messaging for consistency with historical information and in alignment with agreed-upon strategy Capable of providing insight, alternatives, and suggestions based on previous experiences Comfortable working on cross-functional teams with the ability to drive document content to support lean authoring Experience writing protocols, amendments, CSR, and CTD summary documents Technology Skills Expert authoring in MS Word, understanding of MS Word functionality Experience working in document management systems; managing workflows eApproval/signatures Experience working with Word add-ins that facilitate the management of fonts, styles, references, etc. Flexibility in adapting to new tools and technology Capable of training writers/authors on the use of templates, guidelines, and tools RESPONSIBILITIES: Without guidance from senior members of the writing staff, prepare/review clinical study reports, protocols, investigator brochures, submission data summaries, and other regulatory documents on investigational drugs in various stages of clinical development Apply lean authoring principles as part of document development and, when applicable, structured content management text libraries as part of authoring process Coordinate and initiate activities for document review, consensus meeting, quality control, and document finalization under aggressive timelines Develop and maintain project plans Work as an active member of cross-functional teams representing Medical Writing Coordinate and deliver document kick-off meetings with writers and cross-functional representatives Ensure adherence to standard content, lean authoring, and messaging across team members Ensure communication between members remain open and information is disseminated appropriately Possible participation in the orientation and coaching of junior team members Conduct appropriate literature searches and screening, as needed Participate on Medical Writing department initiatives, as appropriate. Research regulatory requirements to remain current in the regulatory landscape Share lessons learned and best practices Ensure compliance with company training and time reporting

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.

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

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

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.

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

TroubleshootingSalient Features of this job * Chance to work in a supportive and flexible environment. * Directly interact with customers from the USA and Europe. * Vedic Lifesciences has been rated highly by our alumni last 22 years, as a great place to work and learn. Job Description: * Overall planning & management of Clinical trials. * Tracking trial progress, developing new study sites, project completion within agreed budget & timeline. * Identifying/selecting an Investigator & Vendor for the conduct of the trial. * Liaising with doctors/consultants or investigators on conducting the trial. * Setting up the trial sites, Training the study staff in SOP`s for CT * Verify that IRB/IEC operates and complies as per GCP, SOP and applicable regulatory requirements. * Monitoring the trial throughout specified duration involving monitoring visit to the trial sites. * Source data verification * Review Investigators Brochure * Informed consent form review, case report form review, investigational drug accountability, and adverse event review. * Writing visit reports, filing and collecting trial documentation and reports * Stakeholder engagement * Sponsor communication * Team handling * Trouble shooting Pre-requisites for - Clinical Operations: * Medical / Life-sciences graduate with in-depth knowledge of Clinical Research project management & fluent English (oral and written) to communicate with global sponsors. * Having 5-8 years of project management in clinical research industry. * Ability to work independently in a complex matrix environment. Good project management skills. * Understanding of Good Clinical Practice. * Presentation, negotiation and conflict resolution skills. * Strong customer-oriented mindset * Ability to resolve issues with minimal supervision. * Willingness to act accountably in project/trial management. * Presentation, negotiation and conflict resolution skills. * Team Management, Good interpersonal skills.

Title Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical Application Support to join our Information Technology team. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Provide timely and accurate support of ClinTrak® applications and other supported applications for internal and external users; Act as a liaison between end users and application development teams while maintaining the interests of end users; Develop and implement approaches for the use of ClinTrak® applications and other supported systems as they apply to individual users and study teams; Provide system Trainings/Demo to Medpace users; and Perform other support related tasks to meet company objectives Qualifications Associate’s degree in Information Systems or a related field and 1 year experience in general IT support -OR- Associate's degree in a Life Sciences field and 1 year of industry-related experience; Strong organizational skills, very detail oriented, flexible, with strong communication skills; Knowledge of Microsoft® Windows operating systems; Ability to work in a team environment; and Experience in Microsoft Office (Excel, Access), and other database system experience preferred. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Title We are currently seeking a full-time, office-based Clinical Safety Coordinator to join our Clinical Safety department in India. This position will be focused on the handling and processing of adverse events from all sources, including clinical trials and post marketing surveillance. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you! Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Determine plan of action for incoming calls; Collect, process, and track incoming adverse and serious adverse events; Write safety narratives; Report on various safety data; and Collaborate with internal departments and investigative clinical research sites to ensure compliance with safety processes. Qualifications Bachelor's degree in Healthcare related field; Nursing, Pharmacy, Pharmacology, etc Clinical experience or Clinical Research, case processing and Post marketing Pharmacovigilance experience is preferred; Proficient English is required Proficient knowledge of Microsoft® Office; Broad knowledge of medical terminology; and Strong organizational and communication skills. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Title Due to our continued growth, we are in need of qualified and focused individuals, like yourself. This is a vital role with our Clinical Safety team whose success relies upon your finely tuned skills and background. If you are ready to make a difference, you must be able to accomplish these tasks: Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Implementation of routine system configuration including product, study and license in Argus and Argus J; Assist with creating reports using Oracle Business Intelligence reporting tool; Resolve safety database-related issues; Prepare/Execute User Acceptance Testing (UAT) of safety system changes; Assist in Argus Database Training for new users, as applicable; Generate outputs from the global safety system in support of periodic safety reports (e.g. DSUR, PSUR and PBRER) ; Assist in the development of system support related process, SOPs, Work Instructions and manuals and Support Inspection and Audits. Qualifications Bachelor’s Degree in scientific discipline or Business Informatics or similar area with 1-2 years of directly related experience; Preferred Qualifications: Work experience in CRO/biotech/pharmaceutical industry. Experience in Study configurations in Safety Systems. Experience with Safety Database preferably Argus and Argus J. Experience in SQL. Experience in reporting and analytic platforms such as OBIEE. Strong client service orientation. Strong consultative problem-solving skills. Ability to combine technical problem-solving skills with discernment to resolve best business solution. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

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

Title We are currently seeking an full time office based Experienced Study Start up Submissions Coordinator to join our Clinical Operations team in India Mumbai. This role is a vital part of the team to accomplish tasks and projects that are instrumental to the company’s success. If you are interested in an exciting career where you can use your expertise and develop and grow your career even further, then this is the opportunity for you. Our culture is of expertise, and we empower our teams to employ their unique talents and experience to take an assertive approach to research, problem solving, and ultimately supporting our business partners. At Medpace, our employees embody our values and our approach to serving our clients. They work hard, understand our high expectations, and rise to the challenge. In return they are rewarded with interesting projects, career advancement, and recognition and exposure to our international footprint. These are just a few reasons why talented individuals join the Medpace team. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Perform required activities within the country that lead to activation of investigative sites in all phases of clinical trials; Prepare, review, and submit to Regulatory Agencies; Communicate with global study teams and personnel on study progress; Ability to effectively identify risks to site activations and mitigate as necessary; Provide expertise and guidance to global study teams in ethics and regulatory submissions; Review and finalize essential documents required for site activation; Act as a main contact for Ethical and Regulatory submission-related activities; Direct contact with investigative sites during the study start up and activation process; Ensure submissions comply with applicable regulations and guidance documents; Advise sponsors on changing regulations and compliance requirements; and Track submissions and ensure timely filing of documents. Qualifications Bachelor's degree in the science field or equivalent combination of education and experience; At least 4 years of relevant working experience at a CRO, Pharmaceutical Company, or an investigative site; Excellent organization and communication skills; Knowledge of Microsoft® Office, ICH - GCP guidelines and regulatory guidelines; Hands-on experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies; including formulating responses to queries; and Good command in English. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Title Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based IRT Validator to join our Randomization and Study Product Management team in Mumbai, India. This position plays a key role in the clinical trial management process at Medpace. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Creation of test plans; Execution of test plans and creation of validation packages; Review of validation packages created by other team members; Review requirement specification documents provided by internal clients; Validation of new projects and changes to existing projects; Qualifications Bachelor’s degree in Math, Computer Science, or related field required; Demonstrated ability to complete validation tasks within defined time frames and to appropriate quality levels; Fluent in English. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Title Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based SAS Programmer to join our Biostatistics team in India, Mumbai. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Write SAS programs for use in creating analysis datasets, tables, listings, and figures Using SAS, program, validate and maintain mapped database Program edit checks for external data Coordinate communication and issues with Data Management regarding database specifications and data transfers Qualifications Bachelor / Master’s Degree in math, Statistics, health informatics, data science, computer science, or life sciences field SAS Ceritifcation SAS knowledge required and 1 to 2 years' experience is preferred Good English written/communication skills is required People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Title We are currently seeking a full-time, office-based Study Start up Submissions Coordinator to join our Clinical Operations team in Mumbai, India office. This role is a vital part of the team to accomplish tasks and projects that are instrumental to the company’s success. If you are interested in an exciting career where you can use your expertise and develop and grow your career even further, then this is the opportunity for you. Our culture is of expertise, and we empower our teams to employ their unique talents and experience to take an assertive approach to research, problem solving, and ultimately supporting our business partners. At Medpace, our employees embody our values and our approach to serving our clients. They work hard, understand our high expectations, and rise to the challenge. In return they are rewarded with interesting projects, career advancement, and recognition and exposure to our international footprint. These are just a few reasons why talented individuals join the Medpace team. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Perform required activities within the country that lead to activation of investigative sites in all phases of clinical trials; Prepare, review, and submit to Regulatory Agencies; Communicate with global study teams and personnel on study progress; Ability to effectively identify risks to site activations and mitigate as necessary; Provide expertise and guidance to global study teams in ethics and regulatory submissions; Review and finalize essential documents required for site activation; Act as a main contact for Ethical and Regulatory submission-related activities; Direct contact with investigative sites during the study start up and activation process; Ensure submissions comply with applicable regulations and guidance documents; Advise sponsors on changing regulations and compliance requirements; and Track submissions and ensure timely filing of documents. Qualifications Bachelor's degree in the science field or equivalent combination of education and experience; At least one year of relevant working experience at a CRO, Pharmaceutical Company, or an investigative site; Excellent organization and communication skills; Knowledge of Microsoft® Office, ICH - GCP guidelines and regulatory guidelines; Hands-on experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies; including formulating responses to queries; and Good command in English. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Title Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Senior SAS Programmers to join our Biostatistics team in India, Mumbai. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Propose and develop specifications for new projects and serve as a project team leader Write SAS programs for use in creating analysis datasets, tables, listings, and figures Using SAS, program, validate and maintain mapped database Program edit checks for external data Responsible for the setup, validation and maintenance of mapped databases, integration of external data with associated edit checks, writing programs independently with good quality for use in creating analysis datasets, tables, listings, and figures. Responsible for mapped database setup, validation and maintenance, and external data integration & edit checks, validation, and maintenance Qualifications Bachelor / Master’s Degree in math, Statistics, health informatics, data science, computer science, or life sciences field 5+ years' eperience with SAS Excellent knowledge of CDISC standards SAS Certification Thorough understanding of the pharmaceutical industry and Federal Regulations regarding electronic records Excellent analytical, written and oral communication skills Good English written/communication skills is required People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to optimize product development and regulatory approvals in International countries develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management. Roles & Responsibilities: Advises Global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives. Provides regulatory direction/expertise on the international regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, expedited regulatory designations, regulatory reliance mechanisms, compassionate use and pediatric plans). Under general supervision, plans regulatory submissions (e.g. clinical trial, marketing authorization applications and lifecycle management) for products within Amgen's portfolio. Under general supervision, contributes to the development of international regulatory strategy documents (regulatory product filing plan, strategies, risks associated with the potential Agency outcomes and contingency planning, estimate likelihood of success) and communicates to others, as appropriate. Provides and maintains clinical trial and/or marketing application documentation (excluding Chemistry, Manufacturing & Controls documentation). May author documents/redact such documents to support a regulatory filing. Directs development of and manages the international label submission strategy, leads the negotiation activities with cross-functional teams and is accountable for the label deviation requests and outcomes. Supports local regulatory teams in triaging queries from health authorities, and where appropriate, helps identify existing responses to same or similar questions, leveraging knowledge management. Participates as a member of the Global Regulatory Team (GRT), and various global clinical and labelling focused teams. Shares regulatory information and implications with the GRT and other global teams on an ongoing basis and provides advice on international considerations. Partners with peers to agree on product strategy including projected submission and approval time. Maintains regular communications with the local teams to ensure alignment on strategy and to share product development status. Builds effective relationships and communication paths across the global, regional and local elements of the global regulatory affairs function. Maintains an awareness of new and developing legislation, regulatory policy and technical regulatory guidance relating to Amgen products. Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement. Basic Qualifications and Experience: Doctorate degree OR Master's degree and 3 years of relevant regional regulatory experience OR Bachelor's degree and 5 years of relevant regional regulatory experience OR Associate degree and 10 years of relevant regional regulatory experience OR High school diploma/GED and 12 years of relevant regional regulatory experience. Functional Skills: Must-Have Skills: Knowledge and experience in the international regulatory environment of clinical trial applications, non-clinical and/or clinical variations to marketing authorizations and product labelling relevant for biotechnology and/or oncology products Comprehensive knowledge of regulatory principles and understanding of regulatory activities, and how they impact other projects and/or processes General awareness of the registration procedures/challenges in International countries for Clinical Trial Applications, Marketing Applications and lifecycle management activities. Good-to-Have Skills: Ability to resolve conflicts and develop a course of action leading to a beneficial outcome Cultural awareness and sensitivity to achieve results across country, regional and international borders. Soft Skills: Strong communication skills, both oral and written Ability to understand and communicate scientific/clinical information Ability to work effectively with global, local and virtual teams High degree of initiative and self-motivation Planning and organizing abilities Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Good negotiation and influencing skills.

YOUR TASKS AND RESPONSIBILITIES: Lead the clinical research medical science related activities such as preparation of synopsis, protocol, Clinical Study Report (CSR) and present the proposals in subjects expert committee (SEC) regulatory meeting. Collaborate with clinicians, KOL to get the feedback and inputs on clinical trial design, comparator and endpoints of the study to finalize synopsis. Review of patient eligibility and approval of patients through Interactive Response Technology (IRT) system Work with data management team to review data management plan, coding plan, SAE reconciliation, CRF completion guidelines, edit check specifications. Also, to ensure timely review of data extract and data cleaning activities to ensure timely database lock and release of tables, figures, and listings (TLFs). Coordinate with biostatistician to engage early with the study team to decide sample size, statistical analysis plan (SAP) apart from review of mock and/or blinded tables, figures, and listings (TFLs), and narrative and discussion planning for relevant documents Prepare risk assessment plan based on the protocol of clinical study to identify and address the safety and operation related risk specific to study protocol. Training the study team on protocol and applied aspect of the protocol to clarify the relevance and criticality of each activity considering the study endpoints. Interact with investigator to resolve the queries related with protocol from the sites and Ethics Committee. Medical monitoring activity which includes eligibility assessment based on inclusion, exclusion criteria and detailed medical history, review of study endpoint data review and safety investigations. Review of Adverse Events and Severe Adverse Events forms and provide review comments in timely manner. Planning publications activities for clinical journal manuscripts, abstracts submission for conferences, and subsequent review of posters/ oral presentations. WHO YOU ARE: MD (Pharmacology) or other relevant medical qualification 2-6 years of relevant experience in the field of Medical Monitoring Experience in working in clinical science domain working in different capacities as medical monitor for clinical trial/ medical expert for clinical development plan for products across therapies is desirable. Job location: Sun House, Goregaon East, Mumbai