2 Senior Clinical Data Manager jobs in whatjobs
Job Description
Our client, a leading Contract Research Organization (CRO) focused on accelerating clinical trials for groundbreaking therapies, is seeking an experienced Senior Clinical Data Manager. This position is based in our office in Nakuru, Nakuru, KE , and requires a hands-on approach to managing complex clinical trial data. You will be instrumental in ensuring the accuracy, integrity, and quality of data collected across multiple studies, playing a vital role in the success of our clients' drug development programs. The ideal candidate possesses a strong understanding of clinical trial processes, data management systems, and regulatory requirements.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Oversee and manage all aspects of clinical data management for assigned clinical trials, from database setup to database lock.
- Develop and maintain clinical data management plans (CDMPs) and standard operating procedures (SOPs).
- Design and validate electronic Case Report Forms (eCRFs) and data capture tools.
- Oversee the creation and execution of data validation plans, including data cleaning and query resolution.
- Ensure compliance with Good Clinical Practice (GCP), ICH guidelines, and relevant regulatory requirements.
- Manage external vendors and databases, ensuring data quality and timelines are met.
- Collaborate with clinical operations, biostatistics, and medical writing teams to ensure data consistency and accuracy.
- Perform data reviews and quality control checks throughout the data management lifecycle.
- Lead database lock activities and prepare final datasets for statistical analysis.
- Train and mentor junior data management personnel.
- Contribute to process improvements and best practices in clinical data management.
- Participate in client meetings to discuss data management strategies and progress.
Qualifications:
- Bachelor's degree in a scientific discipline, computer science, or a related field. A Master's degree is a plus.
- Minimum of 7 years of experience in clinical data management within the pharmaceutical or CRO industry.
- Proven experience with EDC systems (e.g., Medidata Rave, Oracle Clinical, Veeva Vault EDC).
- Strong understanding of clinical trial processes, study designs, and therapeutic areas.
- In-depth knowledge of GCP, ICH guidelines, and data privacy regulations (e.g., GDPR, HIPAA).
- Excellent analytical and problem-solving skills, with meticulous attention to detail.
- Proficiency in database management, data validation, and data reconciliation.
- Strong organizational and project management skills.
- Excellent written and verbal communication skills.
- Ability to work effectively in a team-oriented environment and manage multiple priorities.
- Experience with data standardization (e.g., CDISC SDTM) is highly desirable.
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Job Description
Our client, a leading pharmaceutical research organization, is seeking a highly experienced Senior Clinical Data Manager to oversee the collection, validation, and analysis of data from clinical trials. This hybrid role offers a blend of remote flexibility and in-office collaboration, based in Eldoret. The ideal candidate will have a robust understanding of clinical trial processes, data management systems, and regulatory requirements within the pharmaceutical industry. You will be instrumental in ensuring the integrity, accuracy, and reliability of clinical data, which is critical for drug development and regulatory submissions.
Responsibilities:
Responsibilities:
- Develop and implement clinical data management plans, including data collection, entry, validation, and cleaning strategies.
- Oversee the design and management of clinical databases and electronic data capture (EDC) systems.
- Ensure data accuracy, completeness, and consistency across all clinical trial sites and protocols.
- Develop and execute data validation checks and queries to identify and resolve data discrepancies.
- Collaborate with clinical operations, biostatistics, and medical writing teams to ensure data quality and timely reporting.
- Prepare data management documentation, including data validation plans, edit check specifications, and database lock reports.
- Ensure compliance with Good Clinical Practice (GCP), regulatory guidelines (e.g., FDA, EMA), and company SOPs.
- Participate in the selection and implementation of new data management technologies and tools.
- Train and mentor junior data management staff.
- Contribute to the development and improvement of data management processes and procedures.
- Bachelor's degree in a life science, health science, computer science, or related field. Master's degree preferred.
- Minimum of 8 years of experience in clinical data management within the pharmaceutical or biotechnology industry.
- In-depth knowledge of clinical trial processes, ICH-GCP guidelines, and regulatory requirements.
- Proficiency with EDC systems (e.g., Medidata Rave, Oracle Clinical, Veeva) and data analysis tools.
- Strong understanding of database design, data validation principles, and query management.
- Excellent analytical, problem-solving, and critical thinking skills.
- Strong project management abilities with the capacity to manage multiple projects simultaneously.
- Excellent written and verbal communication skills, with the ability to collaborate effectively with cross-functional teams.
- Detail-oriented with a commitment to data accuracy and integrity.
- Experience in database lock procedures and final data reporting.
This advertiser has chosen not to accept applicants from your region.
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