Data Management Expert Lead
hace 1 semana
Job Overview
The Clinical Data Manager (CDM) is a critical member of our team responsible for overseeing data activities across Phase I-III clinical trials, ensuring seamless compliance with ICH/Good Clinical Practices (GCP) and other relevant guidelines. To excel in this role, the CDM must guarantee that trials are completed efficiently, within budget, and with the highest quality standards.
Key Responsibilities:
- As the primary data management representative, participate in multidisciplinary project teams to ensure successful outcomes.
- Communicate key clinical data management metrics (e.g., data entry status, query resolution, and aging) and determine appropriate actions with the study team to drive efficiency and productivity.
- Review, develop, and write clinical trial documents and manuals, including Case Report Forms, Edit Checks, Data Management Plans, Clinical Data Review Plans, and eCRF Completion Guidelines, maintaining accuracy and adherence to regulatory requirements.
- Collaborate with Clinical Database Programmers to develop Data Flow Charts, Data Transfer Specifications, and Import Guidelines to ensure seamless data transfer and management.
- Assist with training sites and third-party vendors on CDM-related topics, fostering effective knowledge sharing and best practices.
- Provide data review training and guidance to Senior Clinical Data Coordinators supporting the trials, empowering them to take ownership of their work.
- Perform data review and discrepancy resolution as needed, upholding the highest standards of data integrity.
- Archive trials and associated documentation upon completion, ensuring compliance with Good Clinical Practice and all applicable local and international regulations.
Qualifications:
- A minimum of 4-6 years of experience in data management, with a strong background in leading studies independently preferred.
- Experience from startup through database lock, with at least 2-3 startups and 2-3 database locks, providing a solid understanding of the entire data lifecycle.
- Oracle Inc.'s Inform EDC system experience is highly desirable, as well as proficiency in Electronic Data Capture (EDC) systems.
- Bachelor's degree or equivalent experience will be considered, with a preference for those holding degrees in a related field.
- Work history at a Clinical Research Organization (CRO) or CRO management experience in data management is an added advantage.
Estimated Salary: $120,000 - $150,000 per annum, based on industry standards and regional market conditions. This compensation package reflects the company's commitment to attracting and retaining top talent in the field of data management.
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