Role:
Senior-level Clinical Study Lead responsible for operational oversight of global clinical studies within specified regions, ensuring timely, compliant, and quality-driven delivery.
Responsibilities:
Responsibilities include study planning, start-up, execution, vendor management, monitoring, risk mitigation, and study close-out, with a focus on cross-functional coordination, regulatory compliance, and vendor oversight.
Qualifications:
Bachelor's degree in life sciences or related field; 7+ years in pharma, biotech, or CRO with at least 6 years in clinical research, including Phase 1-3 studies management. Experience managing outsourced models, CRO oversight, and regulatory compliance (ICH-GCP, FDA, EMA) essential.
Skills:
Strong project management, risk assessment, global cross-cultural communication, and problem-solving capabilities.
High-Value:
Experience leading regional/global studies, managing CRO/vendor relationships, working within regulated environments, and traveling domestically and internationally.
WorkSetup:
Not specified, but involvement in global studies implies flexible, possibly hybrid or remote work with travel.
#J-18808-LjbffrAssociate Director, Clinical Study Lead in boston at Unknown Company
This position is listed as full time and able to be worked remotely.