MapLight Therapeutics

Lead medical safety evaluation and benefit-risk assessments for products throughout their lifecycle. Oversee cross-functional safety management teams and manage signal detection and regulatory safety documentation.

Perform quality investigator site monitoring and management to ensure subject safety and data integrity in accordance with SOPs and ICH GCP. Collaborate with cross-functional internal stakeholders and external CRO partners to oversee studies from start-up through close-out.

The Lead CRA manages a team of Clinical Research Associates and oversees monitoring quality to ensure compliance with regulatory requirements and company standards. This role combines line management of staff with active site management and monitoring responsibilities for assigned clinical studies.