Senior Manager, 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
- Bachelors Degree with at least 6 years ' experience within a data management role (>2 years' experience in people management), 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.
- At least 2 years management experience.
Responsibilities
- Responsible for ensuring the integrity, reliability, and accuracy of clinical trial data.
- Ensure clinical data quality and consistency conform to regulatory requirements, SOPs, processes, and data standards.
- Ensure external data meets standards outlined in the data transfer specification.
- Ensure all data management activities comply with GCP, regulatory requirements, and Pharmaron Clinical/Sponsor SOPs.
- Ensure data/database programming and development apply CDISC or applicable standards throughout the trial.
- Follow and remain consistent with all Pharmaron Clinical policies and procedures.
- Act as Lead Data Manager for clinical trials: arrange resources, assess workload, define study scope, and create timelines.
- Participate in internal/external meetings, audits, and regulatory inspections.
- Oversee all data management tasks for assigned trials; monitor deliverables to meet timelines and quality standards.
- Communicate effectively with internal and external teams including vendors and clients; provide risk management assessments.
- Mentor and train team members; perform data management tasks as needed.
- Lead clinical data management project teams to deliver services aligned with client needs and contractual obligations.
- Ensure staff compliance with Pharmaron Clinical policies, SOPs, ICH-GCP, and regulatory requirements.
- Participate in project business bidding.
- Identify and implement process improvements; recommend improvement plans 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
