Take responsibility for coordinating the clinical monitoring activities, overseeing the CRO clinical /site management activities and co-monitoring the assigned Phase I clinical studies in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs to the most rigorous standards of quality, timely delivery and within budget, in order to assist in the delivery of Clinical Development objectives and achieve clinical excellence.
Ensure clinical activities coordination & oversight
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 (DM, reg, CMC, etc); ensure feasibility report are exhaustive.
Review site feasibility reports as per oversight plan , support the CPM in site selection, verify timely collection of essential study documents, such as regulatory and ethics committee documents for submission, and by controlling that all set up activities are performed prior to each site initiation, as per the oversight plan.
Validate the final clinical study documents (such as study manual, monitoring plan, prepared by the Clinical CRO.
Support the Clinical CRO in the training of the CRAs on all study specific operational activities and participate in the organization and preparation of the monitor and investigator meetings in collaboration with the other study team members (Corporate and/or affiliates, CROs as appropriate)

Life science or medical graduate or other relevant qualifications.
Minimum: CRA graduated
Relevant experience of pharmaceutical drug development: Experience of minimum 1 year (ideally 2 years) of Lead CRA e.g. coordination of clinical activities/site management activities for the set up and running of international registrational studies (multiple sites/countries).
Experience as a Field CRA monitor for at least 3 years (CROs or Pharma Industry)
Experience in Phase I Oncology
Excellent 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 Contract Research Organizations (CROs).
Global studies (multiple countries/sites) experience
Previous experience in the Therapeutic area of studies (Neuroscience, Oncology or radiopharmaceutical compound, etc.) is a plus.
English: Strong intermediate level

Clinical Team Manager – Senior

Key skills