We are seeking a highly motivated and experienced Senior Clinical Data Manager to join our team. The Senior Clinical Data Manager will be responsible for overseeing and managing all data management activities for clinical trials, from study start-up to database lock.
Responsibilities:
- Oversee and manage all data management activities for clinical trials, from study start-up to database lock.
- Develop and implement data management plans, data validation plans, and other data management documentation.
- Review and provide input on study protocols, CRFs, and other study-related documents.
- Perform data review, query generation, and resolution to ensure data quality and integrity.
- Collaborate with cross-functional teams, including clinical operations, biostatistics, and statistical programming.
- Ensure compliance with regulatory guidelines and company SOPs.
- Participate in the development and implementation of new data management processes and technologies.
- Mentor and provide guidance to junior data management staff.
Prerequisites:
- Bachelor’s degree in a life science, health-related field, or equivalent experience.
- Minimum of 5 years of clinical data management experience.
- Strong knowledge of clinical trial processes, regulatory guidelines (e.g., FDA, ICH-GCP), and industry standards (e.g., CDISC).
- Proficiency in EDC systems (e.g., Medidata Rave, InForm, Veeva Vault CDMS).
- Excellent communication, interpersonal, and organizational skills.
- Ability to work independently and as part of a team in a fast-paced environment.
- Attention to detail and a commitment to data quality.
