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.
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