8 Crf Design Jobs

You will be part of our team as a Senior SAS Programmer, where you will be responsible for providing SAS programming support for TFL generation and offering statistical/programming inputs for CRF design and review. Additionally, you will be involved in developing and validating standard and ad-hoc SAS macros. You will carry out reviews of CRF and aCRF, statistical analysis plans, and programming specifications for efficacy variables. Validating Safety Tables using SAS and ensuring the validation of ADaM and derived datasets will also be part of your responsibilities. Furthermore, you will be involved in validating SDTM datasets and their specifications while adhering to the required training. Desirable Skills and Experience: - Proficiency in SAS programming - Expertise in SDTM and ADaM datasets This position is based in Chennai, India, and requires a Graduate or Post Graduate with a degree in life sciences. The role falls under the managerial category within the Data Sciences department and is a full-time position.,

Working with Us Challenging. Meaningful. Life-changing. Those aren&apost 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&aposll 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 . Supports execution of assigned clinical trial activities and works closely with Clinical Scientist to execute activities associated with trial conduct Supports trial level activities for one or more trials with the necessary supervision Support development of Protocol and ICF documents / amendments Collaborate cross-functionally to monitor clinical data for specific trends Perform medical monitoring of assigned clinical studies Ensure CRF design CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming Conduct literature review. Support submission of clinical documents to TMF Support development of site and CRA training materials Review clinical narratives Seek out and enact best practices with instruction Provide regular and timely updates to manager/management as requested If you come across a role that intrigues you but doesn&apost 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. Uniquely Interesting Work, Life-changing Careers 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. On-site Protocol Responsibilities 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 [HIDDEN TEXT] . 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. Show more Show less

You will be responsible for planning and conducting investigator site selection audits and clinical trial study audits at investigator sites following the applicable GCP guidelines and regulations. Your duties will include reviewing subject ICF and medical records, CRF design, and standard operating procedures. You will need to issue audit reports to the investigator site staff and other study personnel and review and assess audit responses/CAPA for timely closure of audit reports. Additionally, you will be required to provide regular updates on non-compliance or major findings in clinical trials to the Head of Quality Assurance, review Clinical study reports, and offer document review comments in a timely manner.,

As a Clinical Data Management (CDM) professional, you will be responsible for overseeing the full lifecycle of clinical data management processes. Your role will involve ensuring the quality and integrity of clinical trial data, developing and implementing data management plans, and monitoring data entry and validation processes. You will coordinate with clinical teams to ensure timely data collection and conduct data cleaning and review activities. Additionally, you will be preparing data for statistical analysis and reporting while ensuring compliance with regulatory requirements and industry standards. Participating in protocol development and study design, utilizing data management software for efficient data handling, and facilitating communication between project stakeholders are key aspects of your role. You will also be identifying and resolving data discrepancies in a timely manner, providing training and support to junior data management staff, and generating data visualization and reports for project updates. Collaboration with cross-functional teams to streamline processes will be essential in this position. To qualify for this role, you should hold a Bachelor's or Master's degree in Life Sciences or a related field with at least 10 years of experience in clinical data management. Proven experience with data management software and tools, a strong understanding of clinical trial methodologies, and knowledge of regulatory guidelines such as ICH-GCP and FDA are required. Familiarity with statistical software like SAS and SPSS is preferred, along with excellent analytical and problem-solving skills, attention to detail, and strong communication and interpersonal skills. Proficiency in MS Office Suite (Excel, Word, PowerPoint), organizational skills, data visualization, database management, and regulatory compliance are essential for success in this role. Project management experience, professional certification in Clinical Data Management, and the ability to manage multiple projects with competing priorities are advantageous. Your willingness to work on-site in India, strong organizational skills, and the ability to meet deadlines will contribute to your effectiveness in this position.,

As a Manager, Senior Central Testing Analyst within the Clinical Data Sciences (CDS) group of the Clinical Development & Operations (CD&O) organization at Pfizer, your primary responsibility is to oversee and ensure the successful delivery of User Acceptance Testing (UAT) activities for assigned studies. You will collaborate closely with various teams including Clinical Data Scientists, Data Managers, Clinical Database Management, Data Management Reporting and Analytics (DMRA), and other groups within CDS to ensure timely and high-quality deliverables that support the Pfizer portfolio. Your role encompasses a range of key responsibilities, including testing CRF design, database building, acquisition and processing of electronic data, documentation processing, edit checks/validation, and validation of exceptional reports/listings. You will be responsible for assigning and allocating work within the group, managing resources, and overseeing UAT documentation peer reviews and QC processes. It is crucial that you measure and monitor operational metrics, identify and mitigate risks, and address quality issues through RCA and CAPA. Furthermore, you will play a pivotal role in training and mentoring UAT analysts and Data Managers, fostering knowledge development in central testing processes, tracking lessons learned, and ensuring the consistent application of data standards. Your involvement in Data Management meetings, UAT feedback sessions, and continuous process improvement activities will be essential to driving innovation and maintaining high standards within the UAT team. To qualify for this position, a minimum of a Bachelor's degree is required, with at least 10 years of experience in Clinical Data Management within a CRO or Pharma Company. You should have expertise in writing test cases, conducting UAT, and possess a strong understanding of clinical data management processes and principles. Proficiency in Microsoft Office Suite, project management experience, and knowledge of SDLC testing methodology are also desirable qualifications for this role. As part of a dynamic and innovative organization like Pfizer, you will have the opportunity to contribute to special projects, automation initiatives, and team-building activities, all while ensuring high-quality and on-time delivery of UAT tasks. Your commitment to excellence, continuous improvement, and adherence to regulatory standards will be instrumental in advancing Pfizer's mission in the healthcare industry. This role offers a hybrid work location assignment, providing flexibility and work-life balance in a supportive and inclusive environment. Pfizer is proud to be an equal opportunity employer, upholding principles of fairness and diversity in all aspects of its operations. Join us at Pfizer and be part of a team dedicated to making a positive impact in healthcare through cutting-edge research, innovation, and collaboration.,

The Clinical Data Manager is responsible for overseeing all data management activities pertaining to the conduct of Phase I-IV clinical trials in accordance with ICH/Good Clinical Practices (GCP) and other relevant procedures and guidelines to ensure that a quality work product is produced and timelines and deliverables are met. Participate as the primary data management representative on the QED multidisciplinary project teams and as the primary point of contact for all data management interactions with the Sponsor. Participate in protocol developments and review, in review of clinical study reports and statistical analysis plan, in the development of data dictionaries complete with variables, value specifications and coding standards, and in monitoring the quality of data management processes, data, and performance. Review and provide inputs to CRF design and CRF Completion Instructions, database design, data management/data validation plans, data entry guidelines, and revisions to the Standard Operating Procedures. Manage resource planning methodologies and project management to ensure study deliverables and timelines are met in collaboration with the Sponsor, the Sponsor change order process, and to ensure effective communication exchange between the multidisciplinary project teams. Assist/Work with Sr. Management in identifying, developing, and implementing processes to improve/enhance time and cost efficiencies, to provide current information and potential impact of changes on project deliverables and timelines, to identify trouble-shoot issues and provide proposed solutions for problem resolution, to evaluate future potential data management solutions (e.g. functional service provider models, EDC systems) and prepare a business plan, to individual development, training, knowledge, and expertise through research, technical bulletins, and attending appropriate seminars, and to endorse and convey QED's corporate mission statement. Qualifications/Experience: - Bachelor's/Master's degree in computer science, statistics, clinical research, biotechnology, from an appropriately accredited institution. - Minimum of 5 years of data management experience. - Project management experience is required. - Work history at a Clinical Research Organization (CRO) or CRO management experience in data management is required. - Direct management of employees within Clinical Data Management is preferred.,

The role in this Pharmaceutical & Life Sciences full-time job based in Chennai, Tamil Nadu, requires you to oversee the collection, validation, and processing of clinical trial data. You will be responsible for developing and implementing data management procedures for clinical trials, supporting the review of medical coding, and ensuring compliance with applicable regulations, protocols, and standard operating procedures in India. Your role will involve maintaining the highest data quality standards throughout the data lifecycle, from data collection to database lock. It is essential to stay updated on industry best practices, technological advancements, and regulatory requirements related to clinical data management. The preferred candidate for this position should hold certification in clinical data management (like CCDM) and possess knowledge of CRF design, MS Project, and analytical capabilities. Familiarity with CDISC standards and data interchange formats such as SDTM and ADaM is beneficial. Basic knowledge of regulatory guidelines like FDA/CFR, ICH/GCP, understanding of data privacy and protection regulations (e.g., GDPR), and effective communication and interpersonal skills are essential to collaborate effectively with other teams. This role offers the opportunity to contribute to the advancement of clinical data management practices and maintain high standards of data quality in compliance with regulations and protocols.,

As a Data Management Specialist, your responsibilities will include defining project specifications for Data Management services such as Protocol Conversion, Database Build, CRF Design, and Data Review and Data Reconciliation tools. You will need to have a clear understanding of external data collection, its integration into clinical trials, and the processes required for management and reconciliation to maintain accuracy and relevance. Your role will involve executing data cleaning strategies to expedite subject data cleanliness and ensure the delivery of high-quality and timely outcomes. You will be responsible for conducting holistic data review and trending analysis through reporting and elluminate analytics to proactively identify issues, risks, and develop effective mitigation strategies. Utilizing artificial intelligence (AI) and machine learning (ML) for anomaly and outlier detection will be a key aspect of your responsibilities to enhance the efficiency and quality of trial data. Monitoring and interpreting key performance indicators (KPIs), metrics, dashboards, Clinical Trial Operational Analytics (CTOA), and reports will enable you to provide actionable recommendations to study leads or project managers. You will be involved in query management, defining specifications, and collaborating with the technical team on configuring a centralized data management platform, elluminate Data Central for data cleaning strategy and oversight activities. It will also be essential for you to prepare and maintain data management documentation and update them throughout the trial lifecycle. Ensuring the quality control of team-developed deliverables, covering eCRFs, study documents, program/report specifications, outputs, and elluminate Data Central with analytics modules will be part of your role. You will actively evaluate and contribute to enhancing processes to increase efficiency and effectiveness. Collaboration and teamwork are crucial in this role to ensure that deliverables are completed on time and with high quality. Compliance with industry quality standards, regulations, guidelines, and procedures will also be a key focus, along with any other duties as assigned.,