Senior Clinical Data Manager
About The Position
Pharmaron is a global CRO (Contract Research Organization) helping pharma and biotech companies bring new therapies to life. With over 21,000 employees worldwide across 23 locations in the US, UK and China, we support drug discovery through to manufacturing with fully integrated, high-quality services. We're proud of the impact we make and just last year, we supported over 780 discovery projects , 1,000+ CMC programmes , and 1,000+ clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,000 global customers . To learn more, visit www.pharmaron.com .
Requirements
- Bachelor's Degree with at least 4 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 the functions and activities of clinical trials.
- Demonstrated knowledge of GCP and other regulatory requirements for clinical trials.
Responsibilities
- Ensure the integrity, reliability, and accuracy of clinical trial data.
- Maintain clinical data quality and consistency in line with regulatory requirements, SOPs, processes, and data standards.
- Verify external data conforms to data transfer specifications.
- Ensure all data management activities comply with GCP, regulatory requirements, and Pharmaron Clinical/Sponsor SOPs.
- Apply CDISC or applicable standards to data/database programming throughout the trial.
- Adhere to Pharmaron Clinical policies and procedures.
- Act as Lead Data Manager for clinical trials: arrange resources, assess workload, define study scope, and create timelines.
- Oversee all data management tasks for assigned trials; monitor deliverables to meet timelines and quality standards.
- Participate in internal/external meetings, audits, and regulatory inspections.
- Communicate effectively with internal teams, vendors, and clients; provide risk management assessments.
- Mentor and train team members; perform data management tasks as needed.
- Lead project teams to deliver services aligned with client needs and contractual obligations.
- Develop and improve clinical data management SOPs and processes; recommend improvements to senior management.
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
