Senior, Clinical Trial Manager, CTM - FSP (North America, EAST COAST)
About the position Responsibilities • Ensure clinical activities coordination & oversight. • Oversee efficient and thorough study start-up by managing the Clinical team of the CROs. • Support the CPM in site selection and verify timely collection of essential study documents. • Assist in the evaluation of detailed timelines and establishment of clinical studies milestones. • Prepare and assist in the production of documents necessary for clinical activity implementation. • Customize site Key Risk/Performance Indicator templates and monitor them as per the oversight plan. • Review site visit reports and ensure timely follow-up of issues raised by monitors. • Coordinate and manage the CRO relationship, assisting CRO CRAs/CTLs as necessary. • Participate in ongoing clinical study data reviews and ensure data collection timelines are met. • Maintain and review key clinical documents required for Clinical Study Report (CSR). • Act as a client ambassador at site and create relationships with investigators. • Contribute to the efficient operation of the TA Group and participate in SOP updates. Requirements • Life science or medical graduate or other relevant qualifications. • Minimum of 3 years experience as a Field CRA monitor (Independent) in CROs or Pharma Industry. • Experience in oncology and/or neuroscience therapeutic indications. • Minimum of 1 year experience as a Lead CRA coordinating clinical activities/site management. • Excellent knowledge of Good Clinical Practice (GCP) and ICH regulations. • Experience in preparing clinical study documentation for study set up, maintenance, and closing. • Experience in managing relationships with Contract Research Organizations (CROs). • Strong intermediate level of English. Nice-to-haves • Experience in global studies (multiple countries/sites). • Previous experience in the therapeutic area of studies (Neuroscience, Oncology, or radiopharmaceutical compounds). • Basic financial knowledge and ability to work with financial tracking tools. Apply tot his job