18 Crf Design Jobs

Role Overview: As a member of the Pharmaceutical & Life Sciences team, your role will involve overseeing the collection, validation, and processing of clinical trial data. You will be responsible for developing and implementing data management procedures for clinical trials, as well as supporting and facilitating the review of medical coding for validity and completeness. Your key focus will be on ensuring compliance with applicable regulations, protocols, and standard operating procedures in India. It will be essential for you to maintain the highest data quality standards throughout the data lifecycle, from data collection to database lock. Additionally, staying updated on industry best pr...

Role Overview: You will be responsible for overseeing all data management activities related to Phase I-IV clinical trials, ensuring adherence to ICH/GCP guidelines. Your role is crucial in producing quality work products and meeting project timelines. Key Responsibilities: - Participate as the primary data management representative on multidisciplinary project teams and act as the main point of contact for data management interactions with the Sponsor. - Contribute to protocol development, review of clinical study reports, statistical analysis plans, and development of data dictionaries. - Review and provide inputs on CRF design, database design, data validation plans, and revisions to Stan...

As a Clinical Data Manager at Statistics & Data Corporation (SDC), your role will involve participating in all data management activities to support clinical and/or non-clinical research studies. You will work closely with lead Clinical Data Managers and/or Clinical Data Analysts to manage project activities throughout the lifecycle of the projects. Your primary responsibilities will include: - Independently performing study setup activities such as CRF design, database structure design, annotation, DMP, CRF completion guidelines, and data entry screen design - Serving as a primary or backup resource for data management issues - Assisting with management of timelines and communication relate...

Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials. Job Summary: Participates in all data management activities in support of clinical and/or non-clinical research studies for study initiation, setup, maintenance, and closeout working closely with the lead Clinical Data Manager(s) and/or Clinical Data Analyst(s). Manages t...

As a Senior SAS Programmer at our company, you will be responsible for the following key responsibilities: - Providing SAS programming support for TFL generation. - Offering statistical/programming inputs for CRF design and review. - Developing and validating standard and ad-hoc SAS macros. - Conducting a review of CRF and aCRF. - Completing a review of statistical analysis plans. - Preparing programming specifications for efficacy variables. - Validating Safety Tables using SAS. - Preparing and validating ADaM and derived datasets and their specifications. - Validating SDTM datasets and their specifications. - Adhering to required training. Desirable Skills and Experience: - Experience in S...

**Job Description** As a Technical Data Manager at Excelya, you will play a crucial role in performing Technical Data Management tasks to high regulatory standards and Excelya Group SOPs. Your responsibilities will include: - Designing CRF (Unique) in the EDC database, screens design, writing Data Validation Plans, programming edit checks in EDC database, and writing listings specifications as per study specifications - Collaborating closely with the Data Manager & Lead Data Manager for the study - Maintaining global libraries in EDC database - Participating in study documentation and keeping technical specifications documents updated - Adhering to internal technical QC and document updates ...

Senior Biostatistician - India - Office or Home ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Senior Biostatistician to join our diverse and dynamic team. As a Senior Biostatistician I at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. What you will be doing Serves as lead biostatistician for simple to complex clinic...

As a Clinical Study Manager, you will be responsible for developing clinical study designs, writing study protocols, and monitoring plans. You will play a crucial role in training the study team on relevant aspects of clinical studies and ensuring the proper execution of statistical and data management plans. Your key responsibilities will include: - Developing clinical study design - Writing clinical study protocols - Writing study monitoring plan - Training study team on relevant parts of clinical studies - Ensuring statistical plan and data management plan are properly performed - Ensuring study risk analysis plan is properly executed - Designing CRFs (case report forms) and ensuring they...

As a Clinical Data Manager in the pharmaceutical and life sciences industry, your role involves overseeing the collection, validation, and processing of clinical trial data. You will be responsible for developing and implementing data management procedures, ensuring compliance with regulations and protocols, and maintaining the highest data quality standards throughout the data lifecycle. Your key responsibilities include: - Overseeing the collection, validation, and processing of clinical trial data. - Developing and implementing data management procedures for clinical trials. - Supporting and facilitating the review of medical coding for validity and completeness. - Ensuring compliance wit...

Role Overview: As the Clinical Data Manager, you will be responsible for overseeing all data management activities related to Phase I-IV clinical trials. Your role will involve ensuring compliance with ICH/Good Clinical Practices (GCP) and other relevant guidelines to maintain high-quality work products and meet timelines and deliverables. Key Responsibilities: - Participate as the primary data management representative on the QED multidisciplinary project teams. - Serve as the main point of contact for all data management interactions with the Sponsor. - Contribute to protocol developments and reviews, as well as review of clinical study reports and statistical analysis plans. - Assist in t...

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...

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 o...

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 comme...

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 softw...

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, acq...

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 variabl...

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 ...

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...