Hi,
Job Title- Pharma Compliance Analyst
Location- Durham, NC
Contract Role
The Compliance Analyst will work under direction of the Compliance Lead as a member of the Capgemini team establishing several new global data centers for our client, who provides phase I-IV clinical trial management, clinical pharmacology, and other solutions to pharmaceutical and biotechnology companies.
Activities undertaken by this team would include:
– authoring SOP”s, work instructions and checklists
– assessing audit readiness of each site
– reviewing all server validation plans for completeness
– authoring training materials and delivering trainings to the data center teams
– confirming required certifications for each data center
– maintaining a data center compliance dashboard and reporting monthly on compliance matters
– conducting yearly audits and inspections at each data center
– supporting certification updates as required
– evaluating country requirements
– providing updates to SOP”s and trainings when required based on audit findings or changes in regulations?
– minimum 7 yrs experience in pharmaceutical companies.
– minimum 3 yrs experience maintaining regulatory compliance for data centers
– strong awareness of data protection requirements related to HIPAA, PHI and other regulatory considerations
– Excellent Communication, Presentation, Negotiation skills
– Strong Attention to detail
– Proficient MS Office, MS Excel
– Familiarity with quality and compliance management software (Veeva, Trackwise) is a plus
– Ability to travel as needed (~10-15%), including internationally
Thanks & Regards
Deven
Sr. Technical Recruiter
Contact – (929) 479-7249
Email –
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