Job-ID31629249Reference25-04683 Responsibilities: Lead clinical data management activities for multiple complex studies, from study startup to database lock and final reporting. Develop and manage data management timelines for multiple projects, ensuring all milestones are met according to project plans. Design, build, and oversee the implementation and management of clinical trial databases using Electronic Data Capture (EDC) systems (e.g., Medidata, Medrio, or similar). Develop and oversee maintenance all data management documentation for all clinical studies. Ensure clinical data is captured accurately and efficiently, incorporating appropriate data validation checks and edit checks. Oversee data validation processes, including data cleaning, discrepancy management, and query resolution. Ensure data accuracy, completeness, and compliance with regulatory requirements (e.g., FDA, EMA) and industry standards (CDISC, SDTM, WHO Drug, MedDRA). Perform data review and provide feedback to study teams to improve data quality and resolve issues early in the trial process. Ensure clinical data management activities are compliant with regulatory requirements (FDA, EMA), ICH GCP guidelines, and other relevant regulations. Prepare and contribute to regulatory submissions, including clinical study reports, and support data auditing processes. Collaborate with clinical operations, biostatistics, statistical programming, medical writing, scientific and regulatory teams to provide data management expertise in clinical trial planning and execution. Serve as the primary point of contact for data management vendors and external partners, ensuring effective communication and timely issue resolution. Manage independent vendor and CRO biostatistical services performance and oversee compliance with contracts while ensuring budgetary efficiency Develop, implement, and continuously improve clinical data management processes and systems. Lead initiatives to enhance the efficiency and effectiveness of clinical data management, including the evaluation of new tools, software, and methodologies. Requirements: Bachelor's or Master's degree in life sciences, health informatics, computer science, or related field. Advanced degree preferred. Strong understanding of data structure and data systems. Minimum of 5+ years of experience in clinical data management Proven experience managing data across multiple phases of clinical trials Proficiency with EDC systems (e.g., Medidata Rave, Medrio). Strong understanding of CDISC standards (CDASH, SDTM, ADaM) as well as WHO Drug and MedDRA coding. Familiarity with data reporting tools is a plus. Thorough understanding of clinical trial processes, regulatory requirements (e.g., FDA,EMA), and GCP standards. Strong leadership and project management skills, with the ability to manage multiple priorities in a fast-paced environment. Excellent communication, problem-solving, and decision-making skills. Ability to work collaboratively with cross-functional teams and manage relationships with external vendors. Certified Clinical Data Manager (CCDM) or similar certification is preferred.
...other benefits available for associates who want them. Individual medical benefits starting at $10 per week. Employee discounts on Rooms To Go furniture purchases.Join our team. Look around. Does it seem like we're nearly everywhere? That's because we are! With 8,500...
...career where you can make an impact on the health and safety of those around you, we'd love to discuss you joining our team as a Sterile Processing Technician. No prior experience in Sterile Processing? Everyone must start somewhere! We make sure you are trained in all...
...Job Description Description: Midwest Family Mutual Insurance Company is an A- (Excellent) rated property &... ...from-home environment since 2006 and are seeking an entry level Commercial and Personal Lines Underwriter to join our growing team. Key Responsibilities...
...position. Paid time off is earned according to the local policy and increases with the length of employment.WE LOVE OUR WORK.Perform cleaning duties in all areas of the facility including, but not limited to cleaning, sweeping, mopping, washing, waxing, polishing,...
...Job Description Job Description Kelley Dental Laboratory is seeking a reliable, detail-oriented team member for shipping, customer... ...our system accurately Support the team with daily office and lab tasks Qualifications: Strong attention to detail and organizational...