Lead cross-functional teams in clinical research studies within life sciences, ensuring regulatory compliance and data integrity.
Key Responsibilities:
* Act as Study Manager/Principal Investigator for regulatory and non-regulatory studies.
* Generate Study Plans, Data Transfer Agreements, Analytical Reports, and subsequent amendments.
* Review protocols, study plans, reports, SOPs, and scientific papers as required.
* Address internal audit comments related to studies.
* Collaborate with Sponsor/Client/internal teams for Bioanalytical activities.
* Communicate effectively with team members and support new business development activities.
* Drive new business and increase scale and scope of Bioanalytical Services business offering.
* Recognize and resolve issues, and make correct decisions to prevent them.
Requirements:
* Minimum 4-6 years study management experience in regulated bioanalysis small molecule.
* Experience working in a regulatory environment, managing studies compliant with GLP/GCP.
* Experience in a client-facing role, providing high-level advice and guidance to clients.
What We Offer:
* Up to 25% Sign-On/Relocation Bonus Available.
* Sponsorship Opportunity.
* Competitive Pay.
* Comprehensive Benefits Package.
* Career Advancement Opportunities including Apprenticeship.