276 Clinical Data Jobs - Page 7

Challenging. Meaningful. Life-changing. Those aren t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers. bms. com/working-with-us . Key Responsibilities Project Responsibilities: Provides comprehensive programming leadership and support to clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards Leads / Supports the electronic submission preparation and review Develops unambiguous and robust programming specifications (e. g. ADaM specifications) Reviews key planning documents (e. g. , statistical analysis plan, data presentation plan, data review plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements; Assesses document robustness and impact on programming activities Communicates proactively and effectively around issues and risks and contributes to its remediation Improvement Responsibilities: Identifies, leads, and supports opportunities to enhance processes and technology Communicates proactively and effectively around issues and risks and contributes to its remediation Managerial Responsibilities (if applicable): Effectively recruits, manages, develops, evaluates, rewards, motivates, and retains up to 5 direct reports, resulting in an increasing level of capabilities within GBDS Conducts objective setting, performance check-ins, and year-end discussions in compliance with BMS policies; aligns objectives, feedback and performance evaluation with manager Meets regularly with direct reports, focusing on project updates, development needs, issue resolution, and provides real-time coaching and feedback; holds staff accountable for quality and timeliness of programming activities; ensures staff is compliant with training requirements Communicates with manager regarding promotions, performance concerns, and retention risks Builds and maintains a network with stakeholders and peers to ensure cross-functional strategies and objectives intertwine and build upon each other to achieve results Skills, knowledge, and experience Minimum Requirements: Bachelor s degree in statistics, biostatistics, mathematics, computer science or life sciences required At least 8 years programming experience in industry including support of significant regulatory filings Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data Broad expertise in statistical programming and in developing computing strategies In-depth understanding of clinical data structure (e. g. CDISC standards) and relational databases Demonstrated proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools and applications (e. g. MS office, XML, Pinnacle 21) Demonstrated ability in processing of upstream data (e. g. multiple data forms, workflows, eDC, SDTM); Demonstrated ability in providing deliverables to meet downstream requirements, (e. g. ADaM, TFLs, e-submission components) Demonstrated ability to work in a team environment with clinical team members Preferred Requirements: Management experience supervising technical professionals If you come across a role that intrigues you but doesn t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. With a single vision as inspiring as Transforming patients lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms. com . Visit careers. bms. com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers. bms. com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Challenging. Meaningful. Life-changing. Those aren t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers. bms. com/working-with-us . Key Responsibilities Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures; Perform programming validation to ensure quality of analysis datasets and programming outputs Support the electronic submission preparation and review Reviews key planning documents (e. g. , statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements; Assesses impact on programming activities Interacts with vendors regarding project standards, programming conventions, programming specifications and file transfers Provides leadership for ensuring quality of Global Biometric and Data Sciences (GBDS) deliverables by consistently applying standards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work practices Identifies opportunities for increased efficiency and consistency within GBDS and our interactions with strategic vendors Independently leads and / or performs programming assignments across multiple projects with minimal supervision Support improvement initiatives Skills, knowledge, and experience Minimum Requirements: Bachelor s degree in statistics, biostatistics, mathematics, computer science or life sciences required. At least 5 years programming experience in industry. Demonstrated proficiency in using SAS to produce derived analysis datasets and TFLs. Have in-depth understanding of clinical data structure (e. g. CDISC standards) and relational database. Demonstrated skills in using software tools and applications, e. g. , MS office, XML, Pinnacle 21. Demonstrated ability in the handling and processing of upstream data, e. g. , multiple data forms, workflow, eDC, SDTM. Demonstrated ability in providing outputs to meet downstream requirements, e. g. , ADaM, Data Definition Table, e-submission. Have good understanding of regulatory, industry, and technology standards and requirements. Have good knowledge of statistical terminology, clinical tests, medical terminology and protocol designs. Exposure or have working experience on real-world data or real-world evidence Preferred Requirements: Minimum of 5 years clinical / statistical programming experience within pharmaceutical clinical development - Supporting regulatory filings (e. g. NDA, BLA, MAA) Knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirements Experience or solid knowledge in other software, such as R/R-Shiny If you come across a role that intrigues you but doesn t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. With a single vision as inspiring as Transforming patients lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms. com . Visit careers. bms. com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers. bms. com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Job Description Summary As part of the Science and Technology Organization, we develop the services that drive the next generation of healthcare applications and enable developers to build new and innovative solutions that seamlessly span clinical devices & sensors, local compute and storage hubs, and a global footprint of cloud resources. We are looking for a talented and creative expert to accelerate the development of cloud-first, AI-enabled healthcare solutions by building reusable services. GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. Job Description Roles and Responsibilities Work backwards from customers to define the strategy for one of our cloud-first services. Identify target user personas and markets for integration of applications and AI into customer workflows. Clearly articulate value-propositions to drive adoption and relevance. Build cost/pricing models, partner vs build vs buy strategy. Work closely with customers, architects, engineers, and external vendors to prioritize deliverables and ensure releases meet roadmap content and timelines. Work with cross-functional teams to innovate and change the way software is deployed and commercialized to rapidly bring to market new solutions that help unlock, correlate, and analyze the clinical data that powers todays intelligent, precision healthcare. Be equally comfortable digging into business and commercial requirements and digging into operational and deployment strategies with service, architecture and design teams Be flexible, excel when faced with ambiguity and thrive in a fast-paced environment. Have a bias for acting now - then iterate. Required Qualifications Bachelors degree in Engineering, Computer Science or related field with 15+ years of managing and/or activating products in a related industry including hands-on management of large, cross-functional software and system efforts Proven experience in identifying customer s business and strategic needs, concerns, and desires to drive value-adding product capabilities Desired Characteristics Master s Degree in Engineering, Computer Science or related field 3+ years of hands-on software engineering experience Experience leading and/or managing efforts in a distributed systems environment Hands-on experience with Service-Oriented Architecture (SOA) and Cloud solutions Familiarity with Healthcare workflows and deployment scenarios Real world experience with portfolio and investment decisions to balance customer needs, existing product requirements and long term enterprise differentiation Strong written and verbal communication skills Ability to excel in a fast-paced, startup-like environment GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you d expect from an organization with global strength and scale, and you ll be surrounded by career opportunities in a culture that fosters care, collaboration and support. #LI-RS1 #Hybrid Relocation Assistance Provided: Yes

Project entitled :- Investigating the clinical relevance of environmental chemicals and exosomal miRNA biomarkers in the pathophysiology of Polycystic Ovary Syndrome funded by Indian Council of Medical Research. Name of the Post :- Project Research Scientist-I (Medical) No. of vacancy :- One Consolidated Salary :- Rs.87,100/- (Rs.67,000/- plus 30% HRA) Essential Qualification Desirable / Job Responsibilities :- MBBS / BVSc / BDS or equivalent. Desirable Qualification / Job Responsibilities :- Research experience in clinical studies. Experience in writing reports/manuscripts He/she will be looking after overall implementation of the project. He/she will be engaged in screening of the participants, filling case record forms, supervising appropriateness of blood collection and data entry. He/she will prepare the report of the project time to time. Age Limit :- 35yrs Duration / Tenure :- Up to 31.01.2026 (extendable up to 31.01.2027) Interested Candidates can share their cv on this mail id anchal.g@esolglobal.com.

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud - the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. OVERVIEW The Quality Audit Coordinator serves as the central point for all sponsor, regulatory, supplier, and internal audits across the company s eClinical solutions. The role safeguards continuous inspection readiness by organizing evidence, managing logistics before, during, and after each audit, and collaborating with departments across the entire Organization. Success is measured by complete and accurate audit files, on-time CAPA closure, and ongoing process improvements that streamline future inspections. KEY TASKS & RESPONSIBILITIES Pre-audit coordination assists with scheduling audits, confirm audit scope, assembles document packages, schedule interviews with subject-matter experts, and prepare on-site or virtual audit rooms. Live audit support serve as primary scribe, manage real-time document requests, track question/response logs, and controls the flow of materials to auditors. Post-audit follow-up compile meeting minutes, distribute observation summaries, assists in maintaining a findings tracker, and coordinate timely CAPA responses with owners. Maintain audit documentation keep electronic folders and QMS trackers current, version-controlled, and compliant with retention requirements. Support internal quality audits schedule, prepare, and close routine internal audits. Capture and verify records document audit interviews accurately and circulate for stakeholder confirmation. Facilitate cross-functional readiness ensure the various business units have evidence and answers prepared in advance. Assist with vendor audits assist with coordinating assessments of third-party eClinical service providers and monitor follow-up actions. Improve audit processes recommend and implement tools or workflow changes that reduce audit-prep time and strengthen documentation integrity. Update SOPs and work instructions related to audit management and inspection readiness. Perform additional duties as assigned to enhance the Quality Management System and maintain continuous inspection readiness. Education & Experience Bachelor s degree in a related field is preferred 3-5 years of experience working in a pharmaceutical industry is preferred. Knowledge of clinical trial terminology and process. Knowledge of GxP quality standards, applicable regulations, and software development risks. Professional Skills Professionalism, confidentiality, and organization. Excellent writing and typing skills. High level of organizational skills and record-keeping. Ability to work effectively under critical deadlines. Robust communication skills and attention to detail. Technical Skills Ability to pull reports or extract data when needed. Ability to easily learn various software applications. Experience with Qualio or other type of QMS tool Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours! eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here! We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.

Provide basic and some comprehensive data management expertise to the Clinical Data Management (CDM) team to provide efficient, quality data management products that meet customer needs. May also undertake team leadership activities under the supervision of the Data Operations Coordinator (DOC), Data Team Lead (DTL), or Functional Manager. Essential Functions Serve as a Data Operations Coordinator (DOC) for one protocol with less then 5 operations staff (excludes DE) or 15+ easy to moderately complex central laboratory studies, or serve in a leadership role in a specific data management task (eg, coder, tester or database designer for technologies that dont require extensive programming expertise) with guidance. May serve in the role of back-up to a DOC or DTL. May conduct data review. May write and resolve data clarifications. May lead database audit team. May develop and test databases and edit specifications. May perform testing of programming. May perform clinical data coding. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with CDM team Qualifications Bachelors Degree Clinical, biological or mathematical sciences, or related field Req Equivalent combination of education, training and experience in lieu of degree. Medical terminology exposure Excellent organizational, communication, leadership and computer skills Ability to exercise excellent attention to detail Ability to act independently and with initiative required to resolving problems Ability to establish and maintain effective working relationships with coworkers, managers and clients Medical terminology exposure Excellent organizational, communication, leadership and computer skills Ability to exercise excellent attention to detail Ability to act independently and with initiative required to resolving problems Ability to establish and maintain effective working relationships with coworkers, managers and clients

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud - the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. OVERVIEW The Compliance Associate will assist the Sr. Compliance Manager with relevant laws, regulations, and internal policies. Responsibilities will also include managing the Vendor Intake process, conducting vendor audits, and guiding other department personnel thru the vendor management process. KEY TASKS & RESPONSIBILITIES Assist the Sr. Compliance Manager with key compliance-related initiatives such as SOC2, ISO, and other related areas. Manage the Vendor Intake process by working with departmental leaders to assess / re-assess vendors as required. Provide backup support as required to the overall Quality and Compliance team. Respond to co-worker questions regarding compliance regulations and industry best practices. Represent Vendor Management in Audits and ongoing process improvements. Serve as a document coordinator owning the maintenance of Compliance documentation -SOP, WIs, Templates, Forms, ensuring content accuracy and adherence to standards. Other duties as assigned Education & Experience BS degree or job-related equivalency preferred Experience in Quality and Compliance, or similar administrative role Experience and knowledge of compliance regulations and industry best practices Experience working in a fast-paced environment preferred Professional Skills Excellent knowledge of English Strong understanding of business goals and standards for customer service Strong Presentation skills Excellent decision-making skills Strong interpersonal and communication skills Team player and Collaborator that can handle multiple tasks simultaneously in a fast-growing company. Technical Skills Strong time-management and organizational skills Problem-solving skills Analytical skills Adaptable to change Attention to detail Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours! eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here! We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.

Summary Provide expert support and functional and technical knowledge to ensure the scientific integrity/validity for clinical development, early development, and/or research projects. Participate in the full lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. Provide statistical support for regulatory submissions including planning, analysis and reporting of clinical safety and efficacy summaries. May also provide statistical support to research or other R&D areas. -Responsible for advising/leading the planning, development & implementation of Industry (CDISC and regulatory) compliant, high quality, clinical data standards, infrastructure or automation technologies. Providing expert support and stellar customer focus to business users and teams on their use, including: -Data standard collection tools in EDC (CRFs, edits checks, derivations, core configurations) -Data transfer specifications -Analysis data/TFL standards/Define -Automation solutions / technologies -Business infrastructure, business rules and guidelines. About the Role Key Responsibilities Study Level-Responsible for all statistical tasks on the assigned trials, and perform these tasks for mid- to high- complexity trial independently with peer review/input as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plan, reporting activities. Contribute to planning and execution of exploratory analyses, and/or PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation. Initiate, drive and implement novel methods and innovative trial de-signs in alignment with the Lead Statistician. Explain statistical methodology and interpret analysis results. Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities and other drug development activities, as required. Contribute to interactions with external review boards/ethics committees, ex-ternal consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Represent the Biostatistics & Pharmacometrics Line Function on cross-functional teams for the assigned trials. Responsible for functional alignment and ensuring line function awareness throughout the assigned trials. Collaborate with other line functions. Explain statistical concepts in an easily understandable way to non-statisticians and provide adequate statistical justifications for actions/decisions/statements, when required. Establish and maintain sound working relationships and effective communication within the Clinical Trial Team and Biostatistics & Pharmacometrics team. Oversee all Biostatistics resources and deliverables for assigned trials. En-sure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities. Project level- May be a core member of an early project team for a low-complexity program and represents Biostatistics and Pharmacometrics as part of development plan with oversight. Collaborate with clinical, regulatory and other strategic functions to drive quantitative decision making in assigned indications/program with oversight. Collaborate cross-functionally (e. g. data management, programming, medical writing) to ensure timeliness and quality of statistical deliverables. Propose and implement innovative designs and methods to optimize dose finding and drug development. Contribute to planning, prioritization and tracking of program level biostatistics activities and effective partnership with vendors. Significantly contributes to project team preparation for HA Advisory Committees and meetings. Franchise or Global Line Function level: Significantly contribute to initiatives at global line function level Enterprise level- Actively contribute to cross-functional organizational / process /scientific consulting improvement initiatives. Contribute to the review and implementation of health authority guidance. Identify, evaluate, and promote the use and the acceptance within and out-side the organization, of innovative methods, through scientific collaborations, publications in scientific peer reviewed journals, presentations and chairing sessions at professional meetings. External level- Contribute to interactions with external review boards/ethics committees, ex-ternal consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Role Requirements : MS (in Statistics or equivalent) with 7+ years relevant work experience or PhD (in Statistics or equivalent) with 3+ years relevant work experience Fluent English (oral and written) Good communication and presentation skills Influences decisions that directly impact the trial/project and team ability to deliver objectives. Experience in all tasks of a statistician at the trial/experiment level and demonstrated independence in the role. Proven knowledge and expertise in statistics and its application to clinical trials; able to explain statistical designs and concepts. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modelling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Proficiency in use of statistical software packages (e. g. SAS, R). Good knowledge of drug development and Health Authority guidelines. Demonstrated effectiveness working on a multidisciplinary team to achieve team objectives. Good understanding of Franchise/Therapeutic Area and or regulatory activities. Good project management and matrix leadership skills. Ability to collaborate well with non-statistical functions. Good business ethics Commitment to Diversity and Inclusion: Accessibility and accommodation 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:

Job Overview Provide basic and some comprehensive data management expertise to the Clinical Data Management (CDM) team to provide efficient, quality data management products that meet customer needs. May also undertake team leadership activities under the supervision of the Data Operations Coordinator (DOC), Data Team Lead (DTL), or Functional Manager. Essential Functions Serve as a Data Operations Coordinator (DOC) for one protocol with less then 5 operations staff (excludes DE) or 15+ easy to moderately complex central laboratory studies, or serve in a leadership role in a specific data management task (e.g., coder, tester or database designer for technologies that dont require extensive programming expertise) with guidance. May serve in the role of back-up to a DOC or DTL. May conduct data review. May write and resolve data clarifications. May lead database audit team. May develop and test databases and edit specifications. May perform testing of programming. May perform clinical data coding. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with CDM team." Qualifications Bachelors Degree Clinical, biological or mathematical sciences, or related field Req Equivalent combination of education, training and experience in lieu of degree. Medical terminology exposure. Excellent organizational, communication, leadership and computer skills. Ability to exercise excellent attention to detail. Ability to act independently and with initiative required to resolving problems. Ability to establish and maintain effective working relationships with coworkers, managers and clients. Medical terminology exposure. Excellent organizational, communication, leadership and computer skills. Ability to exercise excellent attention to detail. Ability to act independently and with initiative required to resolving problems. Ability to establish and maintain effective working relationships with coworkers, managers and clients. . 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

Assistant Professor (Biosciences) Academic Level 12 Sri Sathya Sai Institute of Higher Learning (SSSIHL) Assistant Professor (Biosciences) Academic Level 12 Department of Biosciences, Anantapur Campus SSSIHL/24-25/Biosci/ACA/046 Full-time (Women applicants) Salary: Basic: 79,800 + Dearness Allowance (DA) & House Rent Allowance (HRA) as per Institute rules Higher qualifications and relevant experience will be considered ESSENTIAL QUALIFICATIONS & EXPERIENCE Ph.D. in Biosciences or any related areas Master s degree in Biosciences or any related areas with a Bachelor s degree in Biosciences or any related areas Good academic performance in relevant fields from a recognized University/Institute Desirable to have cleared UGC NET/CSIR NET/SLET/SET (unless exempted as per UGC regulations for Ph.D. holders) At least 4-5 years of Post PhD experience Ability to introduce and establish cutting edge research in AMR community outreach and epidemiology, or Disease biology experience working with patient samples and data, Multimodal Imaging, Multi-omics in particular working with genomics, Drug discovery/bioinformatics, etc. or working with cell-based techniques for therapy/regenerative medicine, 3D cell culture for drug screening, experience with 3D printing, molecular biology and strain development for recombinant protein expression in bacterial / yeast / insect / mammalian cell culture. Working with community outreach will be a plus with high impact publications Working with more than one of the techniques like clinical data accession or model systems or integrated omic analysis or multimodal imaging or 3D printing and 3D cell culture will be a plus Experience in establishing labs and track record of getting extramural funding Research-oriented mindset with a focus on academic excellence Ability to integrate modern learning tools and research methodologies Proficiency in English and ability to mentor students effectively Commitment to SSSIHL s code of conduct and values-based integral education system KEY RESPONSIBILITIES Teaching and Academic Leadership Introduce new specialization Syllabus design Coaching students for National level exams Enable experiential learning Research and Innovation High impact publications Guiding BS, MSc, MS and PhD Students Guiding internships Raising grants and consultancies Establishment of Research and teaching facilities in field of specialization Student Engagement and Mentorship STEP 2 Attach your detailed resume (must include details of Ph.D. qualification, NET/SLET/SET or other national level exams passed, teaching/professional experience, roles, and responsibilities in chronological order, list of research publications published in reputed UGC CARE journals and conference presentations & proceedings, list of research projects, significant achievements/recognitions, post-docs and research students guided, Areas of expertise and courses taught at UG/PG level, and at least two references (academic and/or professional) STEP 3 Scanned copies of all certificates/documents related to your educational qualifications and professional experience Applicants desiring to apply for more than one position should submit separate applications for each. SSSIHL reserves the right to reject application forms that are incomplete and not as per specified requirements. SSSIHL reserves the right to call only the requisite number of candidates for an in-person demo and/or interview after shortlisting based on the candidate s suitability for the vacant position. There will be no personal communication with candidates other than those shortlisted for the interview. All applicants are required to ensure that all the information submitted (Resume, Annexure form,and documents) is accurate and correct for scrutiny If any application is found to contain information that is inaccurate or false either during the employment process or after the appointment of the candidate, SSSIHL reserves the right to reject the application at any stage or take stringent action on the employee as deemed suitable.

Hi We are hiring for Leading ITES Company for Clinical Data Manager Profile. Role & responsibilities: Candidate should have 2-5 years of experience of CDM with experience in Conduct Scope of work Perform day-to-day Clinical Data Management activities. Experience in doing external data reconciliation Work and coordinate with the team to perform data management activities and deliver an error-free quality database in accordance with the data management plan and regulator standards. Read and understand the study protocol and the timelines. Perform test data entry in the TEST environment, data listing review, data reconciliation, and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate. Perform external checks to handle manual discrepancies and action the same. Ensure an error-free, quality data with no open queries. Escalate any discrepancy in the clinical data to the study lead as appropriate. Timely completion of training Any other tasks deemed appropriate To perform medical data collection and analysis of Prostate Cancer Data using databases like HIS/ EMR (Electronic Medical Record) and Caisis, Rave, CDM (startup, closeout, conduct) Client interaction and meetings. Bringing up new ideas and executing new plans to cope with the backlog. Training new team members as and when required. To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 205 b) To Apply for above Job Role ( Pune ) Type : Job Code # 206 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 207

Job Title: Associate Global Development Scientist Director, Late Development Oncology Global Career Level: E Introduction to role: Are you ready to make a difference in the world of oncology? The Global Development Scientist is an important part of the Clinical Project Team (CPT), and Global Study Team (GST) working synergistically and cross functionally (in a matrix environment) with other CPT & GST members, Site Management & Monitoring (SMM), field based liaisons, and site personnel. The Global Development Scientist and counterpart Global Development Medical Director work collaboratively in the clinical aspects underpinning a clinical program. This includes the shared responsibility with Clinical Operations team members in the planning and execution, including recruitment and delivery of a clinical study. Accountabilities include clinical support for the development and implementation of late phase AstraZeneca sponsored clinical program strategies. This includes providing clinical input into design & implementation of clinical trial(s), their delivery, clinical data review, interpretation of results, reporting successfully on time, and activities required for worldwide registration of the product (i.e. clinical input to NDA/BLA). The Global Development Scientist may also provide expert input or lead functional process improvement initiatives and provide contributions to cross asset or cross tumor area working groups depending on the level of experience. As a key member of the clinical team, this position demands strong collaborative communication skills, including the ability to engage with and influence a diverse range of stakeholders both within and external to AstraZeneca. The individual will operate according to the highest ethical standards in compliance with internal SOPs, local regulations, laws and adhere to Good Clinical Practice and regulatory requirements. Accountabilities: Clinical Development Responsibilities - Supports drafting and review of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports and other Health Authority submissions. - Assists in the implementation of protocols and interactions with vendors and CROs, working closely within cross-functional team. Participates in the development of producing materials for investigator meetings (e.g., slides, booklets, and presentation materials). Assists in triaging and addressing questions regarding scientific and protocol procedures from other study team members and investigative sites. Serves as contact with vendors and CROs regarding medical/clinical science issues. - Support review of clinical data to identify and evaluate study data trends, outliers, protocol violators, etc., and write any necessary queries to be communicated to sites to ensure data accuracy and completeness of the assigned study. - Participate in safety review meetings regarding potential safety events within a given clinical study or across the assigned clinical program. Ensure updates to safety information are shared with cross-functional study team. Support review of safety narratives. - Supports preparation of abstracts, manuscripts, publications, and poster presentations of clinical study findings and results throughout the life cycle of the assigned study or product, as applicable. Supports medical affairs activities, payer and reimbursement activities. - Assists with drafting assigned sections of clinical reports, dossiers, and other documents. - Support Data Management in the build of the CRF and all associated instructions and plans (e.g., CRF completion instructions and Data Review Plan). Technical Skills - Basic understanding of drug development from molecule to market and demonstrates knowledge of scientific methodology in the design, conduct, and description of clinical research at a study level. - Ability to understand and contribute to the drafting of documents used throughout the clinical study lifecycle, such as site initiation materials, registration documents, protocols, and presentations. Demonstrates solid understanding of methodology in the design, conduct, and interpretation of clinical research. Outstanding attention to detail and outstanding written communication skills. - Serves as medical/clinical science representative on study team and collaborates cross-functionally on applicable deliverables during study life cycle (e.g., the protocol, CRF, data listings, TLF, CSR etc.) - Ability to analyze and summarize clinical results. Support creation of and review of clinical slides for internal and external meetings. Essential Skills/Experience: - Required Life Sciences degree or equivalent - PharmD, Ph.D. degree in life sciences, or MD preferred. Strong preference for Oncology experience - Industry or academic experience in drug development required. - Possesses detailed knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research. - Possesses general knowledge of 1) medical monitoring 2) Regulatory approval process in relevant countries; 3) pharmaceutical industry/R&D operations; 4) marketing and commercial fundamentals. - Ability to grow and maintain a high level of expertise in oncology therapeutic area. At AstraZeneca, we are driven by a mission to transform cancer treatment through innovative approaches like novel biomarkers, AI, novel endpoints, and cutting-edge trial designs. Our collaborative environment empowers you to take smart risks and challenge norms while working alongside top experts globally. With one of the broadest oncology pipelines in the industry, youll have opportunities to work with new drugs that truly improve patient outcomes. Ready to join us on this exciting journey? Apply now to be part of our transformative team! 12-Jun-2025 17-Jun-2025

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Job Function: Data Analytics & Computational Sciences Job Sub Function: Biostatistics Job Category: Scientific/Technology All Job Posting Locations: Bangalore, Karnataka, India, Mumbai, India, PENJERLA, Telangana, India Job Description: Principal Responsibilities: Completes programming trial activities of low complexity and/or criticality, with high quality and timeliness of deliverables. Designs and develops programs in support of clinical analysis and reporting activities. May support submission activities including but not limited to creation, verification, and delivery of CDISC compliant and/or non-standard data packages. Performs activities in accordance with departmental processes and procedures. Performs appropriate quality control and verification in support of clinical analyses and reporting activities. Performs review and provides feedback on project requirements and documentation. Collaborates effectively with team and cross-functional members. Ensures continued compliance with required company and departmental training, time reporting and other business/operational processes as required for position. May contribute to departmental innovation and process improvement projects. Clinical Programmer: Reviews specifications for mapping internal Data Review Model (DRM) for fit-for-purpose reporting consumption and ensures verification of DRM. Supports data cleaning by programming edit checks and data review listings and data reporting by creating data visualizations and listings for data management, medical monitoring, and central monitoring. Principal Relationships: This role reports into a people manager position within the Delivery unit and is accountable to the Portfolio and Study Leads for assigned activities and responsibilities. Functional contacts within IDAR include but are not limited to: Leaders and leads in Data Management and Central Monitoring, Programming Leads, Clinical Data Standards, Regulatory Medical Writing Leads, and system support organizations. Functional Contacts within J&J Innovative Medicine (as collaborator or peer) include but are not limited to: Statistics, Clinical, Global Medical Safety, Project Management, Regulatory, Strategic Partnerships, Human Resources. External contacts include but are not limited to external partners, CRO management and vendor liaisons, industry peers and working groups. Education and Experience Requirements: Bachelor s degree or higher and/or equivalent in computer science, mathematics, data science/data engineering/analytics, public health, or other relevant scientific field (or equivalent theoretical/technical depth). Experience and Skills Required: Basic knowledge of data structures and relevant programming languages for data manipulation, and statistical reporting which may include SAS, R, Python etc. Knowledge of SAS is preferred for Clinical Programming role. Basic knowledge of processes, methods, and concepts relevant to programming. Experience working in a team environment preferred. Demonstrated written and verbal communication skills.

Job Summary: We are seeking a highly skilled Lead Data Engineer/Associate Architect to lead the design, implementation, and optimization of scalable data architectures. The ideal candidate will have a deep understanding of data modeling, ETL processes, cloud data solutions, and big data technologies. You will work closely with cross-functional teams to build robust, high-performance data pipelines and infrastructure to enable data-driven decision-making. Experience: 7 - 12 years Work Location: Hyderabad (Hybrid) / Remote Mandatory skills: AWS, Python, SQL, Airflow, DBT Must have done 1 or 2 projects in Clinical Domain/Clinical Industry. Responsibilities: Design and develop scalable and resilient data architectures that support business needs, analytics, and AI/ML workloads. Data Pipeline Development: Design and implement robust ETL/ELT processes to ensure efficient data ingestion, transformation, and storage. Big Data & Cloud Solutions: Architect data solutions using cloud platforms like AWS, Azure, or GCP, leveraging services such as Snowflake, Redshift, BigQuery, and Databricks. Database Optimization: Ensure performance tuning, indexing strategies, and query optimization for relational and NoSQL databases. Data Governance & Security: Implement best practices for data quality, metadata management, compliance (GDPR, CCPA), and security. Collaboration & Leadership: Work closely with data engineers, analysts, and business stakeholders to translate business requirements into scalable solutions. Technology Evaluation: Stay updated with emerging trends, assess new tools and frameworks, and drive innovation in data engineering. Required Skills: Education: Bachelor's or master's degree in computer science, Data Engineering, or a related field. Experience: 7 - 12+ years of experience in data engineering Cloud Platforms: Strong expertise in AWS data services. Databases: Hands-on experience with SQL, NoSQL, and columnar databases such as PostgreSQL, MongoDB, Cassandra, and Snowflake. Programming: Proficiency in Python, Scala, or Java for data processing and automation. ETL Tools: Experience with tools like Apache Airflow, Talend, DBT, or Informatica. Machine Learning & AI Integration (Preferred): Understanding of how to architect data solutions for AI/ML applications

DeepIntent is leading the healthcare advertising industry with data-driven solutions built for the future. From day one, our mission has been to improve patient outcomes through the artful use of advertising, data science, and real-world clinical data. For more information visit, www.DeepIntent.com or find us on LinkedIn. What You ll Do: DeepIntent is seeking a Sr. Talent Partner to join our growing team based in our Pune, India office. In this role, you will support a wide breath of positions across different departments at DeepIntent. You must have experience sourcing and full cycle recruiting for roles across finance, client services, platform operations, marketing, engineering and product. We are looking for an experienced Sr. Talent Partner who has managed full-cycle recruiting and has experience across all facets of the recruiting and hiring process. From sourcing and screening candidates, partnering with hiring managers on hiring strategy, through to offer and negotiations. Due to the partnership nature of this position, you will facilitate and lead meetings with hiring teams to establish and maintain meaningful relationships with hiring teams, interviewers, senior leadership and key cross-functional stakeholders. Manage the full-cycle recruiting process, from initial strategy meetings with hiring managers, to sourcing/screening, facilitating offers and closing candidates Proactively source candidates (active and passive) through referrals, networking and innovative research tactics Create a plan to increase workforce diversity and continue to foster DeepIntent s culture of inclusion Ensure operational excellence, focusing on quality, customer experience and process efficiency Partner with hiring managers, interviewing teams, and senior leadership on hiring initiatives Oversee and manage a detail-oriented and organized process, providing an exceptional candidate experience Effectively communicate and negotiate all parts of an offer package (base, bonus, equity) Establish a partnership and build trust with hiring teams and stakeholders while being the expert in Talent Acquisition Who You Are: 5+ years of experience managing full-cycle recruitment A strong understanding of the digital advertising/adtech landscape Strong verbal and written communication skills; confident in communicating with stakeholders across the organization Experience working for a fast-paced, tech startup and partnering with senior leadership on hiring initiatives Ability to proactively source top talent, gain candidate interest and pitch candidates on DeepIntent s mission, values and goals Ability to negotiate compensation packages and close candidates Working knowledge of Greenhouse strongly preferred We believe great work starts with great support. That s why DeepIntent offers a competitive, holistic benefits package designed to empower you both professionally and personally. Here s what you can expect when you join our team: Competitive base salary plus performance based bonus or commission, comprehensive medical, dental, and vision coverage, 401K match program, generous PTO policy and paid holidays, remote friendly culture with flexible work options, career development and advanced education support, WFH and internet stipends, plus many more perks and benefits! DeepIntent is committed to bringing together individuals from different backgrounds and perspectives. We strive to create an inclusive environment where everyone can thrive, feel a sense of belonging, and do great work together. DeepIntent s commitment to providing equal employment opportunities extends to all aspects of employment, including job assignment, compensation, discipline and access to benefits and training.

The Clinical Trial Physician is responsible for providing medical input within the organization as well as to external partners and performing medical review tasks within the context of clinical trials. Furthermore, the Clinical Trial Physician is responsible for undertaking scientific/medical writing tasks within the organization. Role & responsibilities Is responsible for the development of: All study related documents that fall under the Clinical Science Department scope (e.g., Study Protocols, ICFs - in collaboration with other departments e.g., Clinical Operations, Regulatory, as required -, Pharmacy Manuals, Medical Review Plans, etc.), Scientific presentations and manuscripts, Medical training material (i.e. therapeutic area and study protocol training material) Delivers internal and external study protocol and therapeutic area training courses Provides medical expertise and consultation within the Company on key therapeutic areas of the clinical development program Provides guidance to all involved departments on the medical and scientific aspects of the assigned clinical trials/projects. Responds to medical queries from all involved parties in assigned clinical trials (e.g., CRAs, Project Managers, Clinical Operations Managers, Investigators) and collaborates with all concerned staff in maintaining an up-to-date study-specific Q&A log Is available 24/7 to respond to urgent medical/protocol related issues derived from an Investigational Site, as applicable Performs periodic medical review of the data from clinical trials according to the study-specific Medical Review Plan requirements (e.g., review of eligibility, review of efficacy and safety data). Performs real-time medical review on urgent medical and safety issues, as needed Collaborates with and provides medical input to the Data Management staff to ensure the successful development of the study-specific eCRF Attends Investigator Meetings and Conferences, as applicable Complies with the Company's Quality and Information Security Management Systems and applicable national and international legislation, including legislation for data protection and ICH GCP requirements Preferred candidate profile Required Medical Degree (MBBS, MD) Preferred: Clinical experience in the therapeutic area of the assigned study or of the Companys clinical development program - Preferred: 2 years of experience in a CRO or in the pharma industry in a relevant role (Clinical, Medical Information, Medical Affairs or PV) Key competencies Exceptional written and oral use of English In-depth knowledge of medical and drug terminology Good medical judgement and ability to make medical decisions Excellent communication skills Excellent business acumen Initiative taking and team working attitude Excellent Organizational skills Innovative thinking Excellent IT skills Deep understanding of the Clinical Development industry

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:

Create and execute test plans/UAT scripts for EDC system (Veeva CDMS/Rave EDC). Ensure build quality, validate integrations, document result, and collaborate cross-functionally. Expertise in clinical data system, Agile methodologies, software testing

We are hiring a Business Analyst for the Bangalore location in a Hybrid mode. Role Overview The Business Analyst role is focused on the clinical domain, requiring strong knowledge of clinical trials, clinical research associates, investigators, and subjects (patients). The candidate should be familiar with Electronic Data Capture (EDC) systems and Clinical Research Forms (CRFs). Key Requirements and Skills: SQL Knowledge : The candidate should have a basic understanding of SQL queries. Clinical Domain Expertise : Strong knowledge in clinical trials and related processes. Business Analyst Skills : Understanding of business goals, Agile methodology, and waterfall methodology. Technical Skills : Experience with JIRA, TopTeam, SynapseRT, and proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Project, and Visio). Writing Skills : Strong technical and business writing skills, including knowledge of technical and grammatical editing. Communication Skills : Ability to communicate technical concepts to non-technical audiences and business concepts to technical audiences. Modelling Languages : Ability to learn and use modelling languages when required. Negotiation and Customer Management : Skills in negotiation and customer management. If interested, drop your profile at nusrath.begum@priglobal.com along with the following details: Total Experience: Current CTC: Expected CTC: Notice Period:

Greetings from You & I Consulting! We've proudly helped candidates build careers at 64+ top MNCs across India, and were excited to bring you a new opportunity with a leading global company. If you have experience in Statistical Programming , this role is your next step forward! To Apply: Send your CV via WhatsApp or Call : Puja- (8250242229) or email your resume at :- puja@careersuni.com Shift - General Shift Open Locations :- Mumbai Pune Bangalore Hyderabad Indore Ahmedabad Key Responsibilities: Lead and oversee statistical programming activities for clinical trials at compound/indication/TA level Design and develop SDTM and ADaM datasets as per CDISC standards Generate Tables, Listings, and Figures (TFLs) for clinical study reports and regulatory submissions Manage and review deliverables for eSubmissions, including Define.xml and reviewer guides Provide technical leadership and mentorship to global programming teams Collaborate closely with biostatistics, data management, and regulatory affairs teams Support and lead Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) projects Ensure programming compliance with SOPs, FDA/EMA guidelines, and quality standards Required Qualifications: Bachelors or Masters degree in Statistics, Computer Science, or a related field 10+ years of SAS programming experience in clinical research or pharmaceutical industry Strong hands-on experience with ADaM, TFLs, eSubmissions, and integrated analysis Deep understanding of CDISC standards, regulatory compliance, and submission requirements Prior experience in oncology, neuroscience, or immunology domains preferred Proven leadership capabilities in managing cross-functional and global teams Excellent communication, project management, and problem-solving skills Preferred Tools & Skills: SAS (Base, Macro, STAT, Graph) Familiarity with SDTM/ADaM IG, FDA submission standards Understanding of regulatory submission formats (eCTD) How to Apply / Schedule an Interview: Send your details via WhatsApp or Call : Puja- (8250242229) in the following format: Full Name: Mobile Number: Email Address: Highest Qualification: Total Experience: Current Organization: Preferred Location: Current CTC: Expected CTC: Notice Period: Note: If the line is busy, please drop a WhatsApp message and we will get back to you at the earliest. Referrals Welcome! Know someone who fits the bill? Share this post and help them grow their career! You & I Consulting Your Career Growth Partner

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/#!/

A Day in the Life We believe that when people from different cultures, genders, and points of view come together, innovation is the result and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive. The OSHPI (OU Strategy, Healthcare IT and Product Innovation) Clinical IT Manager role is responsible for creating the best team of Technologists, Data Engineers, and Application Developers to support the Clinical IT organization. This individual will be building and developing a team that provides technical solutions for the entire Clinical IT technology stack. We expect this team to grow significantly over time due to Clinical s need to modernize their enterprise technology stack. This team will be collaborating with the US based Clinical IT team and global stakeholders to deliver solutions supporting the global Clinical organization. This team works with other Global IT employees and external service providers to ensure projects are successfully delivered and supported. Responsibilities may include the following and other duties may be assigned: Recruit and develop the best Clinical and technical talent in the market Partner closely with US based managers, analysts, technologists and architects to deliver and support Clinical IT technology platforms Manage experienced professionals who exercise latitude and independence in assignments Develop early career professionals who require direction and coaching in assignments Receives assignments in task and objective oriented terms. Establishes operational plans and implements policies and strategies Manages budget and labor recovery costs where applicable Strive for continuous improvement and consistency in deliverables. Communicates with internal and external customers and vendors regarding ongoing operations Works with and advises stakeholders, project teams, and peers in areas assigned on project needs and design. Understand and use standard tools, processes, designs, and methodologies for project management, documentation, system development, and implementation. Partner with the US based Clinical IT Managers and Program/Project Managers to ensure alignment and execution of plans with project deliveries. Ensure Medtronics systems and information are protected in accordance with Medtronics Information Protection Policies and Standards, as well as best Information Protection practices. Other duties responsibilities aligning to Medtronic s culture include: Contribute to and cultivate a culture which promotes the development of business capabilities, process excellence, and shared best practice execution Gather, review, assess and partner to drive new ideas, initiatives and projects through innovation, demand and global portfolio processes. Foster a positive, engaging and challenging team-focused global work environment to ensure high productivity, employee engagement, and optimal performance. Act as role model by living and demonstrating the Medtronic Core competencies and values. Required Knowledge and Experience: Experience with implementing large scale enterprise Clinical Research technologies (e.g. Electronic Data Capture, Clinical Trial Management Systems, Clinical Data Warehouses, etc.) Excellent leadership and teamwork skills Strong analytical and critical thinking skills Strong collaboration and influencing skills Strong technical acumen, decision making, and influence skills across all levels of an organization Strong communication skills, including with employees, clients, senior management and vendors Solid presentation skills, including the ability to translate technical information into business terms (e.g., ability to explain complex technical solutions and architecture strategies to non-technical resources) Strong results orientation (driving to deadlines, financial targets, project goals, etc.) Ability to work collaboratively and partner with employees, leaders, clients, and vendors Demonstrated ability to work in a global, virtual organization Work experience in the Medical Device Industry, or other regulated industry Ability to mentor and develop business, architecture, and technical resources Able to work independently as well as cooperatively Benefits Compensation About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission to alleviate pain, restore health, and extend life unites a global team of 95,000+ passionate people. We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the RD lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here

Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Associate Qualifications: BE/BTech/BCA Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be part of our Life Sciences R&D division, which offers a comprehensive range of services across the life sciences sector. This includes Clinical Data Management, regulatory services, pharmacovigilance, and patient services solutions. Employees within this clinical capability will join one of our sub-offerings, such as Clinical Database build and Clinical Reporting. In these roles, you will support leading biopharma companies in realizing their vision, enhancing outcomes by focusing on the patient and integrating scientific expertise with unique insights into the patient experience.The Clinical Reports Programming team is dedicated to developing and maintaining clinical reports for clinical trials. This involves utilizing PL/SQL, SQL, and Clinical SAS programming skills to create these reports. The team also integrates data from various sources such as EDC, Labs, and IRT. Ensuring that all reports comply with regulatory standards and guidelines is a crucial part of their work. They implement stringent quality assurance processes to uphold the highest levels of data integrity and report accuracy. Additionally, the team collaborates closely with clinical operations, biostatistics, and other departments to ensure the reports meet the needs of all stakeholders, facilitating informed decision-making based on accurate and timely data.Develop and review complex reports, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for Oracle Procedural Language Extensions to SQL (PLSQL)Structured Query Language (SQL)Experience in writing programs using Clinical SASClinical Database ProgrammingClinical Data ManagementSAS ClinicalAdaptable and flexibleAbility to perform under pressureProblem-solving skillsAbility to establish strong client relationshipAgility for quick learning Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification BE,BTech,BCA

Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Specialist Qualifications: BE Years of Experience: 7 to 11 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.Develop and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for Generative AI, LLM (Large Language Model), Python skills along with OOPS concept. Understands framework and have understanding on agentic AI building. Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualification BE

Job Title: Medical Intern - Health & Technology Fellowship Location: Hybrid ( Bengaluru) Duration: 45 Days Organization: Eka Care About Eka Care Eka Care is a rapidly growing health-tech startup dedicated to building AI-powered tools that enhance clinical workflows and improve health outcomes. We combine clinical expertise with technological innovation to drive meaningful change in healthcare. Position Overview This 45-day internship gives MBBS students (any year) and graduates a unique opportunity to explore how clinical knowledge integrates with AI. Interns will contribute to high-impact health data projects, experience the pace of a health-tech startup, and gain exposure to standard medical ontologies such as SNOMED CT and LOINC. Key Responsibilities Medical Dataset Curation: Assist in creating and annotating benchmark clinical datasets for AI development. Clinical Structuring: Use your medical knowledge to structure data around diagnosis, symptoms, and treatments. Quality Control: Review ASR (Automatic Speech Recognition) data for clinical accuracy. Medical Database Development: Curate and refine structured medical information, including drugs, diseases, symptoms, and labs. Collaborate with AI and product teams to ensure clinical accuracy and relevance in health tech tools. Who Should Apply MBBS students (any year) or graduates Interested in digital health, clinical data, and AI Comfortable with medical terminology and structured data Detail-oriented and eager to explore standard ontologies like SNOMED & LOINC What Youll Gain Real-world experience at the intersection of healthcare and technology Insights into how medical knowledge fuels AI applications Exposure to clinical data standards and ontologies Mentorship from experienced teams in a fast-paced startup