Study Start Up Lead (m/w/d), befristet für 2 Jahre
Core
Lead the operational setup and initiation of Roche-sponsored clinical trials to ensure timely activation of study sites and regulatory compliance.
Role type
Senior clinical trial study start-up lead
Builds
Clinical trial start-up operations and site activation
Domain
Life Sciences / Clinical Research
Required skills
Clinical trial start-up management, Regulatory submission processes, CRO management, Budget and contract negotiation, Clinical system proficiency (Veeva Vault, CTIS, RIM), Risk management, Stakeholder management
Preferred skills
Process optimization and automation, Amendment management, Cross-functional collaboration
Technologies
Veeva Vault, CTIS, RIM
Responsibilities
Manage start-up activities and ensure timely site activation, Oversee budget and contract processes from creation to data entry, Collaborate with global teams to maintain timelines, Identify opportunities for process optimization and standardization, Communicate with authorities and ethics committees
Seniority
Senior, hands-on IC