Associate Study Start-Up Manager - IQVIA Biotech (Homebased)
Core
Direct and manage site activation, maintenance, and regulatory activities for clinical studies and multi-protocol programs.
Role type
Senior IC Study Start-Up Manager
Builds
Clinical trial site activation and maintenance programs
Domain
Life sciences / Clinical research
Deliverable
client delivery
Required skills
Regulatory strategy, site activation management, multi-protocol program oversight, contract negotiation, regulatory intelligence analysis, clinical practice (GCP) and ICH guidelines application, study financial management, internal systems management (CTMS), mentorship
Preferred skills
Long-standing customer relationship development, presentation and training delivery, budget planning
Technologies
CTMS, tracking tools, project management databases
Responsibilities
Oversee site activation and maintenance execution; develop and maintain project management plans; determine regulatory strategies and parameters; assess regulatory complexity and offer solutions; review regulatory landscape and disseminate intelligence; negotiate contracts and essential documents; ensure quality standards; mentor colleagues; maintain internal systems and project plans; deliver presentations and training; participate in budget planning.
