About the Role
Our client, a prominent contract research organization (CRO) deeply involved in pharmaceutical research, is seeking a highly competent and meticulous Remote Clinical Data Manager . This role is essential for ensuring the accuracy, integrity, and completeness of clinical trial data. You will be responsible for managing clinical data from study initiation through database lock, working entirely remotely. The ideal candidate will possess a strong understanding of clinical trial processes, data management systems, and regulatory requirements (GCP, ICH). This is a significant opportunity to contribute to critical clinical research projects from a remote location, playing a key role in the successful development of new therapies.
Key Responsibilities
- Develop and manage clinical data management plans (DMPs) for clinical trials.
- Oversee the design and implementation of Case Report Forms (CRFs) and electronic CRFs (eCRFs).
- Manage data entry, validation, and cleaning processes to ensure data accuracy and integrity.
- Perform data review and query resolution with clinical sites and study teams.
- Coordinate with biostatistics, programming, and clinical operations teams.
- Ensure compliance with GCP, ICH guidelines, and relevant data privacy regulations.
- Oversee database lock activities and contribute to final database sign-off.
- Contribute to the development and maintenance of data management SOPs and training materials.
- Act as a primary point of contact for data management aspects of assigned clinical trials.
Requirements
- Bachelor's degree in a scientific or healthcare-related field; Computer Science or Statistics background is a plus.
- Minimum of 4 years of experience in clinical data management within the pharmaceutical or CRO industry.
- Proficiency with clinical data management systems (e.g., Medidata Rave, Inform, eClinical systems).
- Strong understanding of clinical trial lifecycle, CDISC standards (SDTM, ADaM), and data validation principles.
- Knowledge of GCP and ICH guidelines related to clinical data.
- Excellent analytical, problem-solving, and organizational skills.
- Strong written and verbal communication skills, crucial for effective remote collaboration.
- Ability to work independently, manage multiple tasks, and meet project timelines.
- Experience with database design and programming is advantageous.
Benefits
This fully remote position offers a competitive salary and a comprehensive benefits package, including health, dental, and vision insurance, as well as a retirement savings plan. Our client is dedicated to fostering professional growth through access to training programs, online learning resources, and opportunities to work on diverse and challenging clinical trials. The flexibility of remote work contributes to an excellent work-life balance. Join a reputable CRO and play a vital role in advancing medical research from the comfort of your home.
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