Senior Clinical Research Associate / Associate Clinical Trial Manager
Core
Support planning, execution, oversight, and delivery of clinical trials from study start-up through closeout for patients with genetic diseases.
Role type
Senior Clinical Research Associate / Associate Clinical Trial Manager
Builds
Clinical trials for genetic disease treatments
Domain
Biotechnology / Pharmaceutical / Clinical Research
Required skills
Clinical trial management, Site monitoring, CRO oversight, Regulatory compliance (ICH-GCP), Clinical data review, Project coordination, Financial tracking, Clinical supply logistics, EDC/CTMS/eTMF systems, Risk management
Preferred skills
Sponsor-side experience, Therapeutic area expertise
Technologies
EDC, CTMS, eTMF, IRT, eCOA
Responsibilities
Manage assigned studies from start-up to closeout; Coordinate internal functions, CROs, vendors, and clinical sites; Provide sponsor oversight of CROs and external vendors; Assist with vendor budgets and financial tracking; Support site feasibility, activation, and monitoring; Collaborate on clinical supply and sample logistics; Contribute to study documentation and workflows; Support clinical data quality and system usage; Ensure regulatory compliance and TMF oversight.
Seniority
Senior, hands-on IC
