3 Crf Specifications Jobs

The Clinical Data Associate II role involves providing data management support for clinical trial projects from study initiation to post-database lock, while adhering to SOPs, regulatory guidelines, and study-specific plans. Your responsibilities include supporting the Lead DM, performing data entry, quality control, developing CRF specifications, building and testing clinical databases, and maintaining data management documentation. You will also be involved in training clinical research personnel, reviewing and querying trial data, conducting medical coding, and assisting with various data-related activities such as SAE/AE reconciliation and vendor coordination. Additionally, you may contribute to SAS programming, troubleshooting operational issues, providing feedback on study documents, and participating in SOP development. Effective communication with sponsors, vendors, and project teams, as well as presenting software demonstrations and attending project meetings, are part of this role. Travel may be required occasionally, and you will be expected to perform other duties as assigned. Qualifications: - Minimum requirement: Bachelor's degree or relevant experience - 2+ years of experience in clinical data management - Proficiency in Microsoft Office applications - Ability to manage various clinical research tasks - Strong organizational and communication skills - Proficient in written and oral English Preferred qualifications include experience in clinical, scientific, or healthcare disciplines. Please note that any data shared during the application process will be handled in accordance with our Privacy Policy. If you require accommodations due to a disability or need assistance with the application process, please contact us at QuestionForHR@precisionmedicinegrp.com. Kindly be cautious of fraudulent job offers, as our organization follows a formal interview process and does not extend offers without communication with our recruiting team and hiring managers.,

Precision for Medicine is looking for an experienced Clinical Data Associate/Senior Clinical Data Associate to provide comprehensive data management support throughout all phases of the clinical trial data management process. In this role, you will ensure adherence to Standard Operating Procedures (SOPs), regulatory guidelines, and study-specific plans under direct supervision. Your responsibilities will include data cleaning and reconciliations, database testing, quality control, and collaboration within a dynamic team environment. The Clinical Data Associate/Senior Clinical Data Associate will provide data management support and assistance in all aspects of the clinical trial data management process from study start-up to post-database lock for assigned projects. You will follow SOPs/WIs, regulatory directives, study-specific plans, and guidelines. This position may involve database development and testing, as well as additional data management activities. Key responsibilities of the role: - Support the Lead DM as a backup or team member, ensuring continuity, responsiveness, and timely task completion - Perform data entry for paper-CRF studies and ensure quality control of data entry - Provide input into timelines, assess resource needs for projects, and ensure clinical data management deadlines are met with quality - Assist in developing CRF specifications from the clinical study protocol and coordinate review/feedback - Assist in building clinical databases and conduct database build UAT - Specify requirements for edit check types and maintain data management documentation - Train clinical research personnel on study-specific items as needed - Review and query clinical trial data according to the Data Management Plan - Perform medical coding of medical terms for logic and consistency - Assist with coordinating SAE/AE reconciliation and liaising with third-party vendors - Assist with SAS programming and quality control of SAS programs - Identify and troubleshoot operational problems and provide feedback on protocols and reports - Participate in the development and maintenance of SOPs related to data management - Communicate with study sponsors, vendors, and project teams regarding data issues - Present software demonstrations/trainings and participate in project meetings - Perform other assigned duties. Qualifications: - Minimum 4 years of experience in Data Management - Bachelor's degree in a scientific/science field with related experience - Proficiency in Microsoft Office tools - Strong organizational and communication skills - Basic knowledge of drug, device, or biologic development and data management practices Preferred qualifications: - Experience in a clinical, scientific, or healthcare discipline - Medical coding knowledge (MedDRA and WHODrug) - Understanding of CDISC standards - Oncology and/or Orphan Drug therapeutic experience Skills: - Strong knowledge of ICH-GCP, Precision Oncology SOPs, and regulatory guidance Competencies: - Motivates project team members and focuses on continuous improvement - Resolves project-related problems and prioritizes workload effectively - Demonstrates self-motivation and professionalism - Works well independently and in a team environment Precision for Medicine is a precision medicine CRO dedicated to advancing the science of precision medicine across various therapeutic areas. All data provided during the application process will be handled in accordance with the Privacy Policy. Applicants with disabilities requiring accommodations can contact Precision Medicine Group for assistance. Note: Precision for Medicine warns applicants about potential fraudulent offers and emphasizes that all job offers will involve communication with the recruiting team, hiring managers, and a formal interview process.,

The Clinical Data Associate II provides data management support and assistance in all aspects of the clinical trial data management process from study start up to post database lock for assigned projects under direct supervision. You will follow Standard Operating Procedures / Work Instructions (SOPs/WIs), regulatory directives, study specific plans, and guidelines. Your responsibilities include supporting the Lead DM, performing data entry for paper-CRF studies when necessary, conducting quality control of data entry, developing CRF specifications, assisting in building clinical databases, and maintaining quality controlled database build documentation. You will also specify requirements for edit check types, create and revise data management documentation, train clinical research personnel, review and query clinical trial data, run status and metric reporting, perform medical coding, assist in SAE/AE reconciliation, liaise with third-party vendors, and may assist with SAS programming. Additionally, you may identify and troubleshoot operational problems, review and provide feedback on protocols and reports, participate in developing SOPs, communicate with study sponsors, vendors, and project teams, present software demonstrations/trainings, and may require some travel. You should possess a Bachelor's degree or a combination of related experience, have at least 2 years of experience, proficiency in Microsoft Office, excellent organizational and communication skills, and professional use of the English language. Experience in a clinical, scientific, or healthcare discipline is preferred. If you are an individual with a disability and need a reasonable accommodation to complete the application process or require an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. Please be aware of potential fraudulent job offers, and note that our organization follows a formal interview process before extending any job offers.,