Clinical Data Manager
About The Position
The Clinical Data Manager ensures the integrity, accuracy, and compliance of clinical trial data, adhering to regulatory requirements, SOPs, and data standards. Responsibilities include overseeing data quality, managing external data transfers, and ensuring database development follows CDISC or relevant standards. They lead study management activities, allocate resources, create timelines, and oversee data management tasks. Additionally, they participate in audits, communicate with stakeholders, assess risks, mentor junior staff, and lead project teams to ensure high-quality data management services aligned with client expectations.
Requirements
- Bachelor's Degree or above in clinical/pharmacy, science and technology, or related discipline preferred.
- At least 3 years' experience within a data management role, understanding of processes including study management, vendor management, CRF design, database set-up, edit check specification, DMPs, and data cleaning activities up to and including database lock.
- Demonstrated knowledge of GCP and other regulatory requirements for clinical trials.
- Demonstrated knowledge of the functions and activities of clinical trials.
Responsibilities
- Responsible for ensuring the integrity, reliability, and accuracy of clinical trial data.
- Ensure that clinical data quality and consistency conform to applicable regulatory requirements, SOP(s), processes, and data standards.
- Ensure that external data conforms to standards outlined in the data transfer specification.
- Ensure all data management activities are compliant with GCP, relevant regulatory requirements, and SOP(s) of Pharmaron Clinical and/or Sponsor.
- Ensure that data/database programming and development follow and apply CDISC or applicable standards throughout the duration of a clinical trial.
- Act as the Lead Data Manager for clinical trials, arrange for resources and assess their workload.
- Identify the work scope of the study and create a study timeline based on the clinical protocol.
- Participate in internal/external functional meetings.
- Oversight of all data management tasks related to a clinical trial as mandated by the scope of work.
- Monitor the project and ensure trial deliverables meet expected timelines and quality standards.
- Participate in internal/external audits and regulatory inspections.
- Provide risk management assessments for data management deliverables.
- Lead clinical data management project teams in the delivery of services to clients to ensure the provided service is consistent with client needs, expectations, and contractual obligations.
Benefits
- Insurance including Medical, Dental & Vision with significant employer contributions
- Employer-funded Health Reimbursement Account
- Healthcare & Dependent Care Flexible Spending Accounts
- 100% Employer-paid Employee Life and AD&D Insurance, Short- and Long-Term Disability Insurance
- 401k plan with generous employer match
- Access to an Employee Assistance Program
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
