Global Clinical Lead--Cambridge, MA
Global Clinical Trial Lead
A growing Boston pharmaceuticals company, focused in Oncology, is seeking a Global Clinical Trial Lead to join their Clinical Operations team. The Global Clinical Trial Lead will be responsible for coordinating the clinical activities, overseeing the CRO clinical /site management activities and co-monitoring assigned clinical studies in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs, timely delivery and within budget, in order to assist in the delivery of Clinical Development objectives and achieve clinical excellence. Coordinate the achievement of registrational clinical study deliverables within a matrix organization and the support of Clinical Development Global Clinical Project Manager (GCPM), Clinical Trial Associate (CTA), any third party staff (CROs). Coach a matrix clinical team to manage the clinical study deliverables on a day to day basis.
- Ensure clinical activities coordination & oversight
- Ensure the monitoring oversight of different activities entrusted
- Ensure efficient and thorough study start-up by overseeing the Clinical team of the CROs and working closely with other relevant team members involved in the study set up to verify timely collection of essential study documents and by controlling that all set up activities are performed prior to each site initiation.
- Support and ensure that all specific EDC system tasks under the clinical responsibility are completed and achieved according to the defined timelines without jeopardizing the start of a trial.
- Co-monitor clinical studies according to the oversight monitoring plan, ensuring adequate contact with investigator sites, identifying and solving issues in study progress, verifying data in-house or by conducting co-monitoring visits, in collaboration with other study team members, and following up as required with CRAs/investigator.
- Participate in the ongoing clinical study data reviews in collaboration with the other study team members.
- Experience in oncology drug development
- 2+ years of experience field monitoring for Oncology trials (CRO or sponsor)
- 2+ years of clinical trial management experience
- Good Knowledge of Good Clinical Practice (GCP), ICH regulations.
- Experience in preparing clinical study documentation for study set up, maintenance and closing
- Experience in managing and developing relationships with CROs
- Experience with global trials
Sthree US is acting as an Employment Agency in relation to this vacancy.