We are currently seeking a Clinical Safety Project Manager to provide support to our Safety and Clinical teams in safety-related pharmacovigilance and study start-up activities. The successful candidate will comply with Chimerix Standard Operating Procedures (SOPs) and processes, as well as Good Clinical Practice (GCP) guidelines and international regulatory requirements, with regards to safety vendor oversight for pharmacovigilance activities for Chimerix investigational compounds and study start-up activities for studies in start-up at Chimerix .
Responsibilities:
- Maintain collaborative, proactive, and effective communication with internal and external (e.g., Chimerix safety vendor, Chimerix CRO) stakeholders regarding safety deliverables across all programs and study start-up activities.
- Conduct Safety Project Management activities and provide technical oversight to deliver quality and efficient solutions across all Chimerix programs.
- Plan, manage, track, and ensure achievement of safety objectives, milestones, and deliverables across studies and programs (e.g., safety requirements for database locks, submission deliverables, periodic reporting, post marketing surveillance work, etc.).
- Manage financial aspects of safety work such as, oversee work orders with external vendors, negotiate scope changes, review/approval of invoices, and oversee monthly/quarterly accrual process within Chimerix.
- Oversee Chimerix safety vendor to ensure complete and accurate safety study files, as well as timely regulatory submissions, distribution, and cross reporting of SUSARs.
- Work with all stakeholders to lead the development of strategies for organizing and preparing safety deliverables.
- Assist in clinical study start up activities.
- Develop, write and/or review clinical trial specific documents and plans including but not limited to clinical monitoring plans, essential document packets for IP release, informed consents, case report forms and study project plans
- Maintain sponsor oversight of the collection, review, maintenance, and tracking of regulatory documents for clinical study centers
- Maintain sponsor oversight of CROs including monitoring oversight visits, training, issue escalations and ensure protocol adherence, and ICH GCP requirements
- Provide input and oversight of TMF set-up and ensure overall accuracy and completeness of study Trial Master File, including applicable safety documentation.