660 Clinical Trials Jobs - Page 12

Core Objectives The Quality Management (QM) Team is passionate about improving the quality of patient care by building intelligence into our athenaClinicals Electronic Health Record service. This is accomplished through the addition of point of care alerts around standards of care as well as identifying and building support for payer-based compensation and/or quality incentive programs. Our team is responsible for leveraging clinical data in the patient chart to improve our clients ability to successfully demonstrate improvements in the quality of care. The Quality Management (QM) Analyst is a critical contributor to this process. As a QM Analyst, you will work closely with teams across our data-driven company to research, prioritize, and build payforperformance programs and clinical guidelines into our expanding quality management library. You will work with the quality management tools in our Electronic Health Record service, athenaClinicals, to support client participation on pay-for-performance and pay-for-value initiatives. To succeed you will need to be a strong analytical problem solver, have excellent attention to detail and be able to work with a vast amount of information in a fast paced setting. You will have the capacity to plan and take responsibility for small projects independently and large projects collectively. You should be able to strive in both independent and team environments and be comfortable communicating between the business and development teams. You will act as a trusted advisor to internal and possibly external clients. Essential Duties And Responsibilities Responsibilities may include, but are not limited to: Develop knowledge on quality improvement trends in the healthcare industry, sharing this knowledge with multiple stakeholders Learn the Quality Management tools, workflows and reporting capabilities of our Electronic Health Record, athena Clinicals Understand, assist with inputs to develop and implement QM analysis and reporting processes, tools and metrics Work closely with team members to evaluate and prioritize new quality program development, including analysis of the clinical and financial impact to clients using these programs Understanding of business escalations and provide satisfactory responses. Manage internal and external stakeholder relationships through clear and concise communication and reporting, specific and measurable goals, aligned incentives, and clear expectations Ability to execute assigned projects with cross-functional teams using your excellent written and verbal communication skills to achieve success Become an active participant in athenahealths teaching and learning culture Key Skills And Abilities Technical Skills Strong computer literacy, including advanced Excel, Word, Power Point knowledge and web/internet tools Strong aptitude for developing and understanding big-picture QM use cases with attention to detail required to identify potential obstacles and mitigate risks Demonstrated success in using data and adding knowledge-based insight when making business decisions Soft skills Professional attitude comfortable working in a corporate setting populated by diverse types of people and able to maintain poise and a sense of humor in stressful situations Demonstrated success in managing projects with cross-functional interdependencies Excellent organizational skills, analytical ability, and strong attention to detail Flexibility and willingness to take on new tasks and challenges Understanding of medical terminology and EMRs as well as an understanding of measuring clinical quality and outcomes Flexibility and the ability to handle rapidly changing priorities as needed Excellent communication skills, including listening, writing and relationship development Enthusiasm, idealism, creativity, dedication, a sense of humor and an open mind Project Management Skills Ability to learn and work with project owners and above on the projects Basic project management skills and the desire to become more effective helping towards project success Capacity to plan and take responsibility to own mini-projects independently and collectively on large scale projects Professional attitude comfortable working in a corporate setting populated by diverse types of people as you become stronger in timely and efficient stakeholder communication Work Experience And Education Bachelors degree - Preferred Life Science background. Minimum 3 + years professional experience, healthcare experience preferred Work experience with athenaNet preferred Work hours are 1 to 10pm IST

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 . Position: Internal Audit Analyst II, Global Internal Audit & Assurance (EG 90) Location : Hyderabad, India Reports To : Associate Director, IT Audit At Bristol Myers Squibb, we are inspired by a single vision - transforming patients lives through science. Across oncology, hematology, immunology, neuroscience, and cardiovascular disease, with one of the most diverse and promising pipelines in the industry, each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. Position Summary The Internal Audit Analyst II in GIA will work in a team environment to plan and execute dynamic risk-based audits and identify value-added recommendations to strengthen Company processes and controls. Audits will include U. S. -based operations, international Company subsidiaries, strategic initiatives, critical business processes, and key third-party outsourcing arrangements. Throughout the audits, the Senior Internal Audit Analyst will have the opportunity to interact with senior management and enhance oral and written communication skills. Key Responsibilities Key responsibilities include, but are not limited to: Work collaboratively with audit teams to execute financial, operational, compliance, and integrated IT audits. Actively participate in planning activities to identify significant risks and develop appropriate risk-based audit procedures. Research applicable policies, guidance, and regulations to drive assigned sections of the audit with high quality and within deadlines. Leverage existing data analytics AI use cases and assist with build and enhancement projects, when assigned. Interview key personnel to assess business processes and the strength of their control environments. Identify meaningful value-added recommendations for management to improve the adequacy, effectiveness, and efficiency of controls and related processes. Actively participate in meetings involving various levels of management to effectively communicate audit status, align on significant audit issues and recommended corrective actions. Prepare clear, detailed audit documentation evidencing the results of actual testing procedures in accordance with BMS and the Institute of Internal Auditors (IIA) standards. Prepare audit reports, including clearly written, concise audit observations that effectively communicate identified issues and their related corrective actions to key stakeholders. Participate with the team in trainings and regular departmental meetings that include sharing best practices. Participate in departmental projects as assigned (e. g. , audit lessons learned, training, continuous improvement, etc. ). Qualifications & Experience A BA/BS degree in Data Science, Computer Science, Information Systems, Accounting, Finance, or other business discipline. A minimum of 3 years prior public accounting or internal audit experience, including experience in financial, operational, IT or compliance auditing. Knowledge of U. S. GAAP and IIA standards. English fluency. Strong verbal and written communication skills. Proficiency with Excel/Word/PowerPoint. AI and Data analytics experience (specifically with visualization tools such as Tableau) and ERPs. Desirable Qualifications & Experience MBA or other advanced degree. Professional certification (i. e. , CPA, CA, CIA, CISA or equivalent). Experience with a Big Four firm. Experience in developing written reports and delivering presentations. Multilingual (verbal and written). Key Capabilities of Focus Leadership : Pursues tasks with a sense of urgency. Shows accountability by taking ownership of assigned responsibilities and completing them on time, with the highest quality. Demonstrates speed and innovation to get things done; can simplify complex processes; knows of and can leverage resources to drive tasks/projects forward across functions and within the function. Able to identify risk and quickly develop an understanding of complex processes. Works effectively in ambiguous situations and adapts quickly in a rapidly changing environment. Collaboration: Works well in a team environment, fostering inclusion and building effective relationships with both team members and customers. Displays excellent ability to communicate across various levels of management, including with executives, to explain identified issues and related corrective actions. Digital Proficiency: Actively works toward improving data analytics capabilities and developing digital acumen. Gathers relevant information and critically evaluates it to define next steps and propose a solution. Business Acumen: This role requires strong and proven ability to understand local and micro business dynamics, identify risks and opportunities. Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential of each of our colleagues. 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. Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or 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. 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.

The Project Research Scientist II (Non-Medical) plays a crucial role in shaping the direction and success of clinical and health services research projects. This position requires expertise in scientific research, good organizational skills, and the ability to navigate complex regulatory environments. Primary Responsibilities: Develop and refine study designs to ensure scientific rigor and alignment with research objectives. Analyse data according to study statistical plan tailored to the studys specific needs, ensuring that data collection methods align with intended analysis strategies. Compile comprehensive reports for relevant committees and funding agency, that summarize the study progress, challenges encountered, and future directions. Organize project meetings to manage progress and timelines Preparing manuscripts for scientific communication. Site Audits: Conduct regular site visits to ensure compliance with study protocols and Good Clinical Practice (GCP) guidelines. Address any deviations or concerns related to study execution. Data Audits: Perform thorough audits of collected data to verify accuracy, completeness, and adherence to the study design and ethical standards. Team Collaboration: Work closely with a multidisciplinary team, including data managers, statisticians, other researchers, and clinical staff, to ensure that all aspects of the study are Minimum required qualifications/experience: First class post-graduate degree, including integrated PG degrees, with three years experience or Desirable: Experience in clinical or health services research, including expertise in study design and research methodology. Experience in conducting/managing operational feasibility studies Excellent written and oral communication skills, capable of effectively presenting research findings and writing complex reports. Demonstrated ability to lead and manage research projects, including coordination of Knowledge of regulatory standards and ethical guidelines pertinent to clinical research. Strong attention to detail and commitment to accuracy. Good organizational skills and ability to manage multiple tasks.

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

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

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

: Provide basic and some comprehensive data management expertise to the eCOA Data Management (DM) team to deliver efficient, quality data management products that meet customer needs. May also undertake eCOA Data Management activities under the supervision of the Data Team Lead (DTL)/ Sr DTL, or Functional Manager. Essential Functions: - Undertake eCOA Data Management activities for assigned studies, with/without supervision. - May serve in the role of back-up to a DTL. - Perform testing of programming and data transfers. - Understand and comply with core operating procedures and working instructions. - Meet objectives as assigned and develop and maintain good communications and working relationships within eCOA DM team. - Database Design and Maintenance: Create and maintain clinical databases to ensure they are efficient and meet the needs of the clinical trials. - Data Querying and Reporting: Manage queries and generate reports for analysis. - Data Validation: Analyze and resolve discrepancies from Recon/CTMS inquiries. - Study Close-out: Execute end-to-end study close-out activities, include Archival. - Identify opportunities to automate and improve data collection and management processes. Qualifications: - Bachelor s degree in pharmacy or equivalent preferred. - 3-6 years of direct data management experience, preferably a minimum of 1 year as a CDM project lead. - Good to have experience in electronic Clinical Outcome Assessment (eCOA) or Decentralized Clinical Trials (DCT). - Advanced proficiency in English, both spoken and written. - Advanced skills in computer applications like Microsoft Excel, Word, Outlook, etc. - Advanced understanding of the drug development lifecycle and overall clinical research process.

Job Summary The Sr Product Specialist (ISG) will play a crucial role in enhancing and managing our Veeva CTMS and Veeva systems within the Research and Development domain. With a hybrid work model and day shifts the candidate will collaborate with cross-functional teams to ensure seamless integration and functionality of these systems. This role requires a deep understanding of Veeva technologies and R&D processes to drive innovation and efficiency. Responsibilities Lead the implementation and optimization of Veeva CTMS and Veeva systems to support R&D activities. Oversee system configurations and ensure alignment with business requirements. Collaborate with stakeholders to gather and analyze system needs and translate them into technical specifications. Provide technical expertise and support to end-users ensuring smooth operation of Veeva systems. Develop and maintain documentation for system processes and configurations. Conduct regular system audits to ensure data integrity and compliance with industry standards. Coordinate with IT teams to troubleshoot and resolve system issues promptly. Facilitate training sessions for users to enhance their understanding and utilization of Veeva systems. Monitor system performance and implement improvements to enhance efficiency. Engage with vendors and external partners to stay updated on the latest Veeva technologies and best practices. Drive continuous improvement initiatives to optimize system functionality and user experience. Ensure compliance with regulatory requirements and company policies in all system-related activities. Support project management activities including planning execution and monitoring of system-related projects. Qualifications Possess a strong background in Veeva CTMS and Veeva systems with hands-on experience. Demonstrate expertise in Research and Development processes and requirements. Exhibit excellent problem-solving skills and the ability to work independently. Have a proven track record of managing and optimizing enterprise systems. Show proficiency in collaborating with cross-functional teams and stakeholders. Display strong communication skills to effectively convey technical information to non-technical audiences. Certifications Required Veeva Certified Administrator Veeva Vault Certification

Perform triage & intake of ICSR received daily in ARGUS databases Should have hands On Experience On ARGUS Safety Database Should Have hands on Experience on MEDDRA Applicants Should Complete Certification in Pharmacoviiglance Required Candidate profile B.Pharm / M.Pharm/Pharm D/Life sciences degree With Hands On Experience On Argus Safety Database and Med DRA coding, Argus, Narrative Writing, Triage Should have good communication Skills

Leads project-specific certification activities at the direction of the Manager, OCMPG and Ophthalmic Certification Project Managers Performs certification data entry and works in the certification database at the direction of the Manager, OCMPG and Ophthalmic Certification Project Managers Assists with providing support in tracking, compiling, and submitting project deadlines and deliverables Assists with the collection of electronic and paper-based project files and archives Assists with the review of study related documents, certifications and data to ensure quality and accuracy Supports the coordinating of conference calls and meetings Edits, formats, tracks and distributes technical and non-technical reports Attends and participates in department team meetings Performs other duties as assigned Overview Ophthalmic Certification Project Associate India - Bangalore Emmes Group: Building a better future for us all Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience We believe the work we do will have a direct impact on patients lives and act accordingly We stive to build a collaborative culture at the intersection of being a performance and people driven company We re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company If you share our motivations and passion in research, come join us! This requirement is for our OptymEdge division OptymEdge sets the gold standard for training and certification in ophthalmic clinical trials and brings experience and expertise from having the largest and longest-standing certification organization in the industry Pioneering visual acuity certification from conception, we have developed proven solutions for training and certification of Visual Function Examiners and Visual Function Rooms, and partner with study teams to provide visual function certification that ensures a high level of quality and consistency for ophthalmic clinical trial data OptymEdge has certified over 2000 sites worldwide since 1995, working on Phase I through post-marketing trials in clinical Ophthalmology, Optometry, and other therapeutic areas Primary Purpose The Ophthalmic Certification Project Associate (OCPA) is critical to the successful conduct of ophthalmic certifications in Biopharmaceutical-sponsored clinical trials The OCPA supports the Manager, Ophthalmic Certification Project Management Group (OCMPG) and Ophthalmic Certification Project Managers by providing logistical support for electronic document filing and archiving, reporting requirements and other duties required by the statement of work The OCPA will be site-facing through the life cycle of the study, and contributes to team and financial efficiency, work product quality, and client satisfaction through strong relationship management Responsibilities Leads project-specific certification activities at the direction of the Manager, OCMPG and Ophthalmic Certification Project Managers Performs certification data entry and works in the certification database at the direction of the Manager, OCMPG and Ophthalmic Certification Project Managers Assists with providing support in tracking, compiling, and submitting project deadlines and deliverables Assists with the collection of electronic and paper-based project files and archives Assists with the review of study related documents, certifications and data to ensure quality and accuracy Supports the coordinating of conference calls and meetings Edits, formats, tracks and distributes technical and non-technical reports Attends and participates in department team meetings Performs other duties as assigned Qualifications Bachelor s degree preferred or equivalent experience will be considered 2 years demonstrating related experience Demonstrated experience with MS Office Suite, particularly MS Word Time management and decision-making skills Attention to detail and the ability to address several assignments simultaneously Excellent oral and written communication skills Some knowledge of clinical trials in ophthalmology preferred CONNECT WITH US! Follow us on Twitter - @EmmesCRO Find us on LinkedIn - Emmes

About SCPA We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers. About the role We have a opportunity for a Medical Device Assessor/ Auditor to join our India Team. The successful candidate will be responsible for, planning and conducting audits/ assessments, in accordance with ISO 13485, EU MDR, and MDSAP standards and related (eg IMDR). Key Accountabilities: Technical Compliances, Accreditation Requirements and collaborating with a Team of Auditors/ Assessors. Conduct audits (either desk-based or on client s sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships. Conduct Technical File reviews specific for products being authorized. Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business. Complete specific projects in relation to medical device procedures, processes, systems and documentation. If required, undertake reviews of packs and make certification decisions within target timescales and in line with DNV policies and accreditation/approval requirements. Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards. To be considered for this role, you ll require about 10 years of professional experience in relevant field of healthcare products or related activities e.g.: work in medical devices industry such as research and development, manufacturing, quality management, regulatory affairs: work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies. work in the application of device technology and its use in health care services and with patients. testing devices for compliance with the relevant national or international standards. conducting performance testing, evaluation studies or clinical trials of devices. 5 + years relevant professional experience in quality management is essential. In addition to the above you ll also need to demonstrate the following. An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques Good knowledge of ISO 13485, MDD 93/42/EEC/ Indian Medical Device Regulations and their application Knowledge of MDR 2017/745, MDSAP, IMDR Work experience in positions with significant QA, Regulatory or management systems responsibility Experience with Harmonized medical device standards and for active non active devices. Experience with Risk Management EN ISO 14971 Experience auditing against recognized standards Experience of working under own initiative and in planning and prioritizing workloads Solid knowledge of non-active devices Solid knowledge of sterilization processes The following attributes are essential: Work actively with a Team of Assessors/ Auditors. Experience of reviewing audit packs Review of technical documentation Registered IRCA lead auditor, or equivalent registration under other recognized body What we offer Flexible work arrangements for better work-life balance Generous Paid Leaves (Annual, Sick, Compassionate, Local Public, Marriage, Maternity, Paternity, Medical leave) Medical benefits ( Insurance and Annual Health Check-up) Pension and Insurance Policies (Group Term Life Insurance, Group Personal Accident Insurance, Travel Insurance) Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme) Additional Benefits (Long Service Awards, Mobile Phone Reimbursement) Company bonus/Profit share. *Benefits may vary based on position, tenure/contract/grade level* About you University or technical college degree or equivalent qualification in relevant sciences such as: Medicine, Pharmacy, Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Health Technology, Toxicology, Physics, Biophysics, Material Science Biomedical Engineering, Computer Software Technology, Engineering, Nursing, Quality Management. Qualified MDR Assessor from a reputed EU Notified Body, desirable. Experience with scientific literature searches or peer review in the medical context. Fluent in written and spoken English. Experience working with Various Digital Tools. Excellent organizational and professional communication skills.

Job Overview: Provide basic and some comprehensive data management expertise to the eCOA Data Management (DM) team to deliver efficient, quality data management products that meet customer needs. May also undertake eCOA Data Management activities under the supervision of the Data Team Lead (DTL)/ Sr DTL, or Functional Manager. Essential Functions: - Undertake eCOA Data Management activities for assigned studies, with/without supervision. - May serve in the role of back-up to a DTL. - Perform testing of programming and data transfers. - Understand and comply with core operating procedures and working instructions. - Meet objectives as assigned and develop and maintain good communications and working relationships within eCOA DM team. - Database Design and Maintenance: Create and maintain clinical databases to ensure they are efficient and meet the needs of the clinical trials. - Data Querying and Reporting: Manage queries and generate reports for analysis. - Data Validation: Analyze and resolve discrepancies from Recon/CTMS inquiries. - Study Close-out: Execute end-to-end study close-out activities, include Archival. - Identify opportunities to automate and improve data collection and management processes. Qualifications: - Bachelor s degree in pharmacy or equivalent preferred. - 3-6 years of direct data management experience, preferably a minimum of 1 year as a CDM project lead. - Good to have experience in electronic Clinical Outcome Assessment (eCOA) or Decentralized Clinical Trials (DCT). - Advanced proficiency in English, both spoken and written. - Advanced skills in computer applications like Microsoft Excel, Word, Outlook, etc. - Advanced understanding of the drug development lifecycle and overall clinical research process. . 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

We are looking out for a Sr. Clinical Research professional who has a relevant experience and has excellent knowledge. Beacon Targeted Therapies ( https: / / beacon-intelligence.com / ) Beacon provides a customizable, modular, cloud-based software-as-a-service platform that enables you to personalize drug development data and analysis so that it seamlessly integrates into your daily workflows. The solutions are designed to enable multinational pharma, biotech and anyone with a vested interest in the progress and development of new therapies to conduct: Target discovery and analysis Candidate screening and benchmarking Market entry and exit strategy Trial design and development Translational science analysis Key Responsibilities Lead and manage a research team in order to curate accurate, timely, insightful and comprehensive data and intelligence. Identify and analyse the most relevant information for Beacon and its users. Coordinate with UK based clients on a regular basis to understand and meet the project deliverables. Manage the activities required towards launch of a beacon module and further support the needs towards maintenance post launch. You will be part of a global network of life science researchers working on dynamic, fast growing products in exciting, cutting edge life science areas. Perform data management activities on the assigned project in a timely and efficient manner Generate queries to clarify and improve the quality of the data. Strong understanding of Clinical Trials and their data Strong understanding on preclinical data What attributes will you need An ideal candidate might be a subject matter expertise in various drug therapies in field of oncology (Antibody drug conjugate/Bispecific/Adoptive cell therapy/Checkpoint modulators/oncolytic virus/Gene therapy) and experience with managing a team of resources. Proven ability to deal with complex life science concepts Excellent written and verbal communication skills. Previous experience in a research role and/or data-oriented role is desirable but not essential. Experience and understanding in the field of pharmacology, drug discovery and development and clinical trials would be a bonus. Good project and people management skills are a must have. Results-oriented, passionate about delivering value and impact, proactive. Most of all, you will need to be curious and willing to learn at all times. Eligibility Masters in Pharmacy (except Pharmacognosy) / Biology / Bio-Technology / Bio-Chemistry / Pharm D with minimum 2-3+ years of relevant experience Bachelors in Pharmacy (except Pharmacognosy) / Biology / Bio-Technology / Bio-Chemistry with at-least 4 years of relevant experience Candidates with additional Clinical research diploma or relevant courses can apply. Candidate should have basic computer skills, Microsoft Office detailed Internet Knowledge. Candidate should have one research paper published Ability to work in a high-pressure, deadline-driven environment Exceptional communication and reporting skills Pune, Maharashtra Apply Now To apply please email your CV to hr@ascentrik.com or fill the form below. To apply please email your CV to Join Grow at

Identify new sites, PIs and Assists in evaluating new protocols for feasibility at the site. To coordinate with Principal Investigator, Institutional Review Board/ Institutional Ethics Committee, Sponsor/CRO & Team for conduct of the clinical research/trials. Reviewing the protocol/synopsis and other materials, such as NDA, feasibility questionnaire and Approached to PIs as per study indication for further process discussion. Assessing the ability to meet the study timelines in light of other site commitments and overall feasibility Looking at subject eligibility requirements and determining if those subjects would be available in the practice. Assessing the resources necessary to do the study, including people, physical space, etc Collecting curriculum Vitae, MRC, and GCP Certificate of Principal Investigator, sub- Investigator and other study professionals, and send along with completed Site feasibility questionnaire. Assessing for Site Selection Visit (SSV) & Site Initiation Visit (SIV). To conduct the clinical trial according to ICH-GCP guidelines, New drugs and Clinical trials rules 2019, and other applicable regulatory guidelines. To systematize processes in order to attend high level of standards during research process. Preparing documents for submission to the Institutional Review Board (IRB)/ IEC Attending the Investigator meeting, as appropriate, and train staff about their duties related to the ongoing clinical trial. To obtain and document the Informed Consent form which should comply with the applicable regulatory requirements and adherence to GCP and to the ethical principles that have their origin in the declaration of Helsinki. Presenting the informed consent form to potential subject, discussing the consent and the study with them and answering questions. Obtaining subject s signatures on the informed consent forms, and ensuring that all necessary signature and dates are on the ICF. Documenting, distributing and filing assigned informed consent forms appropriately. Ensuring that all amended consent forms are appropriately implemented and signed. To ensure that neither the investigator nor the trial staff, should coerce or unduly influence a subject to participate or to continue participate in the trial. To ensure that the rights and we'll-being of the subjects are protected. To provide patient Information sheet to the subject. Contacting and screening potential subjects for the study. Recruiting Subjects, Scheduling Subject and Sponsor Visits. Preparing for each subject visit to ensure that all appropriate study procedures are done. Assisting the Investigator with study subject visits. Ensuring that All necessary data are gathered and recorded in the appropriate source documents (ie, Patient charts) and the case reports forms. Reviewing case report forms entries for completeness, correctness and logical sense in addition, review the source documents and case report orms for adverse events that may have been missed. Working with sponsor monitors (CRAs) during monitoring visits. Making corrections to the case report forms, if appropriate and resolving data queries. Managing laboratory procedures (drawing samples, Processing, packaging and shipping). Preparing Invoices and managing payments to study subjects, if appropriate. Preparing Invoices and managing payments to study subjects, if appropriate.

Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our clients innovation. As a Principal Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowe'red to work with autonomy and ownership. This is an exciting time to be a part of this new program. Position Overview: This position reports to the Director, Biostatistics and Programming in the FSP Services business unit in Cytel. The Principal Statistical Programmer works independently with only concept level instruction and very little supervision, tracks progress, and provides expert technical support to team members. We are looking for a highly experienced senior statistical programmer who will work on clinical development programs on different therapeutic areas and participate in overseeing CRO programmers to ensure that data summaries are delivered in a consistent, high-quality manner. This individual will be responsible for implementing all reporting and analysis activities for the Sponsor clinical trials. Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have: At a minimum bachelors degree in computer science, data science, mathematics, or statistics major preferred 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device development, or intervention studies Exceptional SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment Extensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities Must be able to work independently Outstanding communication skills (written and verbal) and strong leadership skills Preferred Qualifications (nice to have) Prior work experience with pharmacokinetic data and the neuroscience field, proficiency in languages or tools other than SAS (eg, R, Python, and Java, Shiny, Markdown, Unix/Linux and git) As a Principal Statistical Programmer, your responsibilities will include: Generate SDTM, ADaM specifications, datasets, reviewer s guide and define.xml files for multiple studies Develop SAS programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs needs Participate in overseeing CRO s statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelines Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions. Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros Participate in the development of CRFs, edit check specifications, and data validation plans Provide review and/or author data transfer specifications for external vendor data Collaborate with internal and external functions (eg CROs, software vendors, clinical development partners, etc) to ensure meeting project timelines and goals Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices

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

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

Responsibilities: * Prepare clinical study reports and protocols. * Ensure compliance with ICF and ICH-GCP guidelines. * Collaborate on clinical research projects. * Write medical communications for regulatory submissions. Provident fund

1. Follow-up with collaborating institutes (pre-clinical & clinical studies) for study/studies. Follow-up, primary data competition & preliminary statistical analysis. 2. Finalisation and data check of the studies completed, statistical analysis and follow-up with pharmacologist for final data analysis and report writing. 3. Preparation of study product introduction (disease burden & actions) for incorporating in the final study report and discussion section. 4. Follow-up for publication and initiating the publication for completed studies. 5. Identifying new institutes across India for standardization, pre-clinical [esp. understanding mode of action] & clinical studies [mainly Ayurved institutes]. 6. Preparation & documents / docket for new-clinical studies [GCP of investigators to CTRI registration. 7. Product support/Short communications for old / new studies for marketing department. 8. Preparation of study data PPT for field and Doctors. 9. Updation of Project files [Institutes-MOU-Budget-Protocol, etc. Excel sheet, Final Report Publication and Release of funds]. 10. Basic training of current field staff / new recruits. 11. Presenting our study data in conferences and seminars.

What you will do Let's do this. Let's change the world. In this vital role you will leverages domain, technical and business process expertise to provide exceptional end user support of Amgen's external suppliers to ensure their effectiveness to deliver Amgen clinical trials for Amgen study teams. This role involves working closely with internal and external business stakeholder and support analysts to ensure rapid resolution of technical issues, performing route cause analysis and implementation of long-term preventative solutions. You will collaborate with the Product Owner and a team of other Business Analysts to ensure operational support excellence from the team. Roles & Responsibilities: Build strong relationship with key business leads and external partners to ensure their needs are being met Oversee expedited resolution of business-critical issues affecting the delivery of key external business partners Work with Product owner and business stakeholders to collected details requirements and user stories Analyze technical and process problems and work with multi-functional owners to develop solutions Maintain accurate documentation of configurations, processes, and changes Maintain detailed system and user documentation What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a with these qualifications. Basic Qualifications: Bachelor's degree and 0 to 3 years of Life Science/Biotechnology/Information Systems experience OR Diploma and 4 to 7 years of Life Science/Biotechnology/Information Systems experience Preferred Qualifications: Must-Have Skills: Customer focused with excellent written and verbal communication skills who can confidently work with internal Amgen business stakeholders and external service partners on technology topics Experience of working with or supporting systems used to execute clinical trials. E.g. Rave, CTMS, Veeva Excellent problem-solving skills and a committed attention to detail in finding solutions Good-to-Have Skills: Experience of working with or in a Clinical Research Organizations (CROs) or other specialist suppliers supporting clinical trials Experience with Agile software development methodologies (Scrum) Knowledge of network security protocols and tools (e.g., IPSEC, SSL, IDS/IPS, firewalls) Experience of O365 Cloud PC VDI Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Highly organized and able to work under minimal supervision Excellent analytical and assessment skills Ability to work effectively with global, virtual teams Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Familiarity with GxP, CFR 21 Part 11 and systems validation Ambitious to further develop their skills and career

Role & responsibilities Proficiency in organizing and communicating clinical information Excellent attention to detail, consistency, clarity and scientific rigor Continuous improvement and growth mindset Ability to work in a fast-paced and changing environment Accountable, focused, precise attitude Customer-service mentality and can-do attitude Exceptional command of written and spoken English at a professional level with the ability to write clear, concise and grammatically flawless medical/scientific content. Job Responsibilities 1. Works closely with cross-functional project teams to independently author scientifically accurate, comprehensive and compliant documents, including but not limited to clinical study reports, clinical study protocols, manuscripts, informed consent forms, patients narratives, abstracts, posters, oral presentations, etc 2. Manages the collection, consolidation and integration of comments/feedback from internal and external reviewers to efficiently finalize assigned writing projects 3. Performs thorough quality control checks, including copyediting, proofreading, and cross-verification of data within clinical documents and against source TFLs to ensure accuracy, consistency, and compliance with regulatory standards. 4. Ensure that the assigned deliverables strictly adhere to regulatory guidelines (e.g., ICH-GCP, EMA/FDA requirements), publication guidelines (ICMJE, GPP, journal/congress-specific requirements), client specifications, and Veeda's quality standards for content, format, and structure. 5. Streamline the review process by identifying and mitigating potential conflicts early, enabling the timely completion of high-quality deliverables. 6. Provide supervision and technical advice to other medical writers in the team and new writers joining the team, as required. 7. Apply broad therapeutic knowledge to adapt writing style and content for different disease areas and target audiences 8. Conduct literature reviews on assigned therapeutic areas and provide scientific support across departments throughout the clinical study lifecycle, ensuring adherence to timelines and project requirements. 9. Quickly assimilate new therapeutic area information to support emerging project needs 10. Maintain awareness of evolving guidelines and standards across relevant therapeutic fields 11. Provide support to Medical Writing department activities as needed

Job title: R&D Change Management Specialist Location: Hyderabad About the job Our Team: Sanofi Global Hub (SGH) is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions . Change Management Specialist As a Change Management Specialist, you play a pivotal role in ensuring successful transformations and modernizations across the organization. The key focus is on the people side of change, preparing, supporting, and equipping employees to adopt and use changes related to business processes, systems, technology, job roles, and organizational structures across Sanofi R&D. He/she will be responsible for coordinating tasks with the R&D change specialist assistants when applicable. Key responsibilities would include: Develop and Implement Change Strategies Leverage a structured methodology to create change management strategies and plans that maximize employee adoption and usage of required changes utilizing the standard Sanofi Change Management playbook and approaches. Identify and engage key stakeholders, ensuring their buy-in and support throughout the change process Anticipate and minimize resistance from impacted employees and stakeholders. Drive Adoption and Proficiency: Increase adoption, utilization, and proficiency with changes, ultimately enhancing benefit realization, ROI, and outcomes. Collaborate with senior leaders, executives, people managers, and project teams to integrate change management activities. Assess Impact and Support Communication: Conduct impact analyses and assess change readiness. Identify and monitor the adoption before and after go live Based on these metrics, develop action plans to mitigate resistance and enhance adoption. Support the execution of the change management plans Enable the design, development, delivery, and management of key communications and any other activities fostering adoption of the change. Pursue this support over an hypercare period to secure strong change adoption Mitigate Risks and Ensure Preparedness: Assess and mitigate risks associated with change initiatives. Ensure employees are adequately prepared for upcoming changes. Measure change management effectiveness: Monitor the effectiveness of change activities, report on progress and outcomes. About you Experience in Change Management, Communications and/or Marketing, preferably in the pharmaceutical field is desired. Project management skills/experience is desired. A solid understanding of pharmaceutical processes, product development, and regulatory requirements. Familiarity with drug development stages, clinical trials, and manufacturing processes. Proficiency in change management principles, methodologies, and best practices. Ability to assess the impact of changes on processes, systems, and personnel. Excellent verbal and written communication to convey change-related information effectively. Ability to engage stakeholders, manage expectations, and address concerns. Strong problem-solving skills to evaluate proposed changes and their implications. Capacity to identify risks, benefits, and potential obstacles. Experience working cross-functionally with teams, including R&D, quality, and regulatory affairs. Ability to influence and guide stakeholders toward successful change adoption. Comfort with evolving processes and changing priorities during product development. Agility to handle frequent adjustments and updates. Education : Bachelors Degree or the equivalent in Life Sciences, Business, Communication or a related field, Certification in change management (e.g., Prosci, ACMP) is a plus ; Familiarities with artificial intelligence would be a plus Languages : Excellent communications skills, both verbal and written in English. Pursue Progress . Discover Extraordinary . Progress doesn t happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let s pursue progress. And let s discover extraordinary together. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !

Are you looking for a meaningful and fulfilling career in Project Management within the Clinical Research industry? Join Clarios Medical Imaging team in Bengaluru, India, and be part of a legacy with over 30 years of expertise. We specialize in providing seamless, secure, and compliant medical imaging solutions that enhance clinical trials. At Clario, we have ambitious goals and a clear vision for the future. This is your chance to be part of our journey as a Clinical Project Manager. What we offer Competitive compensation Attractive benefits (security, flexibility, support and well-being) Engaging employee programs Technology for hybrid working and great onsite facilities What youll be doing Identifies project guidelines and communication needs by: Reviewing study requirements and response assessment criteria and collaborates with key stakeholders to develop study start-up activities and associated documents Defining project plans (i.e. timelines, milestones and limitations for project staff) Establishing project reporting schedules Providing project updates to BD Director, Global Services Managing Directors, Sponsor representative(s) on schedule Communicating timely, appropriate project information to project teams, sites and company/sponsor representative(s) Performs project analysis and management by: Identifying critical project success factors for tracking, analysis and reporting Determining needed resources for project completion and communicating needs to appropriate departmental managers Collaborating with department leaders for appropriate training of those involved with the project toward excellence in successful and timely completion of project Performing financial tasks including monthly billing, forecasting, project scope reviews and amendments, and pass-through cost management Possessing a thorough understanding of the project contract and totals needed for monthly revenue reporting Understanding SOPs and working closely with QA for clarification and documentation of deviations Training and maintaining project team knowledge and applications of SOPs Communicating all protocol clarifications/revisions to project team Coordinating site management of data collection with internal and external teams Provides project team leadership by: Leading by example with professional and collaborative conduct Developing and delivering team project training Establishing team performance expectations and guidelines Providing input to departmental managers of respective team members performance level Analyzing team performance for consistency/quality within established project guidelines Collaborating with the departmental managers for team coaching/mentoring Supports Business Development efforts by: Collaborating with BD Director in the development and presentation of company capabilities calls/meetings Attending professional meeting(s) as Company representative Delivering polished Investigator Meeting presentation projecting solid comprehension of project/protocol and company services Oversees project close out by: Assisting with coordination of submission activities, as applicable Assisting with initiating and overseeing all project close out activities to completion Performs supervisory functions by, if applicable: Communicating job expectations Planning, monitoring and appraising job results Coaching, counseling and disciplining staff Initiating, coordinating and enforcing systems, policies and procedures Approving direct reports time sheets, requests for time off and/or overtime Performing timely performance evaluations of direct reports Coordinating and conducting new hire interviews; facilitating hiring decision Training new hires on departmental processes and responsibilities Maintains Quality Service and Departmental Standards by: Reading, understanding and adhering to organizational Standard Operating Procedures ( SOP ) Establishing and enforcing departmental standards Reviewing and updating company SOPs related What we look for Bachelor s degree required or commensurate experience level. Educational majors in life sciences, pharmacy, nursing, or other healthcare field highly desirable Previous management or project experience in clinical development of investigational medications required 3 + years clinical trials experience within a CRO or pharmaceutical research organization required; preferably in a project management related role. Working knowledge of GCH, ICH guidelines and FDA regulations Medical Imaging experience a plus Experience working with computer software including Word, Excel, Access and Project preferred Strong interpersonal and communication skills, both verbal and written Strong organizational and leadership skills Goal oriented Ability to maintain professional and positive attitude .

Summary Strategically and tactically supports Director Clinical Data Standards. Responsible for advising/leading the planning, development and 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. May lead global teams. About the Role Major accountabilities: Ensuring alignment with the CDS strategy; Responsible for Clinical Data Standard/automation solution planning, definition, development, validation and support Serves as the primary contact for global / TA data standards and/or technologies ensuring timely and quality deliverables. Responsible for driving efficient, high quality and timely implementation of new standards and/or technologies. Ensure efficient governance and approval of global clinical data standards / technologies liaising with governance boards as needed. Lead the technical review and assessment of industry and regulatory standards and technologies supporting regular gap/impact analysis and implementation of action plans where needed. Lead and contribute to the development, maintenance and training of relevant clinical standards systems and processes. Act as an expert consultant providing Clinical Data Standards input to all relevant areas including electronic data capture/database programming, edit check programming, report programming, electronic data loads, IVR technology, electronic patient reported outcomes, metadata management and/or other clinical data management or analysis data and TFL-related systems. Act as primary subject matter expert (SME) for assigned area providing support, consultation and training to end users and SME networks on implementation of standards and related tools on development programs. Provide mentoring and technical guidance to Clinical Data Standards associates; Contributes to the effectiveness and development of talent. Key performance indicators: Timely execution of of projects and data requests; Feedback from project sponsors and key stakeholders Adherence to Novartis policy and guidelines -Metrics and Adherence to KPIs Work Experience: Managing Crises. Functional Breadth. Project Management. Collaborating across boundaries. Representing the organization. Skills: Automation. Biostatistics. Clinical Trials. Computer Programming. Cross-Functional Teams. Data Analytics. Decision Making Skills. 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:

Job Title: Associate Director Data Management Work Location: Manyata Tech Park, Bangalore, India Work Schedule: Three days on-site, two days remote (3/2) Career Level: E - People manager position. Introduction to role Are you ready to lead and inspire a team in Clinical Data Management (CDM)? As an Associate Director, youll oversee the delivery of high-quality data for assigned projects or indications, whether through external partners or internally run studies. Youll stay at the forefront of industry trends and serve as a subject matter expert in process development and improvement. Join us in making a difference in the world of biopharmaceuticals! Accountabilities As a team leader, youll provide training and coaching to junior colleagues within CDM. Perform line management responsibilities such as performance appraisals and mentoring. Represent Clinical Data Management at cross-functional forums and meetings, providing timely feedback to partners. Understand health authority requirements and provide input into CDM-related activities associated with regulatory inspections/audits. Provide CDM leadership for assigned projects, taking global accountability and serving as the second line of contact at the project level. Demonstrate leadership and operational expertise in strategic planning and delivery of CDM deliverables at the project level. Manage vendor contracts, resourcing, budget management, and vendor performance for assigned projects and studies. Communicate and negotiate effectively with all other project-level team members. Apply consistent CDM processes and documentation across assigned projects to ensure data quality. Oversee external service providers or in-house teams to deliver quality data with compliance to study model procedures and standards. Responsible for proactive risk management and issue resolution/escalation related to CDM improvement or technology. Develop an understanding of CDASH and SDTM or other recognized industry standards. Specialize in TA-specific data capture and standards, conducting lessons learned and disseminating knowledge across the organization. Provide data management expertise in supporting strategic and operational aspects of Data Management at the project level. Demonstrate willingness to take on and lead any project-level activity consistent with current experience in support of study delivery. Perform any CDM-related ad-hoc requests from Line Manager. Essential Skills/Experience University or college degree in the life sciences or related subject, pharmacy, nursing or equivalent relevant degree. Ability to successfully manage simultaneous trials and meet deadlines. Significant Clinical Data Management experience, preferable both from CRO and Pharma industry in more than one therapeutic area. Excellent understanding of clinical trials methodology, GCP, GDMP and medical terminology. Comprehensive knowledge of clinical standards, e.g., SDTM or CDASH. High attention to detail and a strong analytical mind-set. Demonstrates a comprehensive knowledge of database structures and of capturing and storing clinical information as they apply to CRF design, database development, data handling and reporting. Excellent interpersonal skills and proven ability to operate effectively in a global environment. Good written and verbal communication skills, negotiation, collaboration, conflict management and interpersonal skills. Cultural awareness. Experience of CRO and vendor management. Desirable Skills/Experience Experience as a lead of a large Phase III trial or multiple smaller trials. Knowledge of SQL, 4GL, VBA or R software. Experience of managing teams. At AstraZeneca, we are driven by our passion for science and our commitment to making a meaningful impact on patients lives. We are dedicated to exploring innovative solutions for some of the worlds most complex diseases. By integrating digital technology with scientific advancements, we aim to accelerate breakthroughs that can redefine healthcare. Our collaborative environment brings together diverse expertise from academia, biotechs, and industry to create swift impacts on disease. Here, curiosity thrives, empowering us to make bold decisions that shape the future of medicine. Date Posted 30-May-2025 Closing Date 07-Jun-2025