Global Clinical Lead/Lead CRA, Oncology

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 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. 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 Assistant (CTA), any third party staff (CROs). Coach a matrix clinical team to manage the clinical study deliverables on a day to day basis.

Responsibilities

Responsibilities will include, but are not limited to, the following:

• 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 (DM, Reg, CMC etc...): to 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.
• Support and ensure that all specific Ipsen/CRO 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.

Education

Life science or medical graduate or other relevant qualifications.

Experience

• Relevant experience of pharmaceutical drug development:
• Coordination of clinical activities for the set up and running of registrational studies, as well as site management activities.
• Experience as a Field CRA monitor at least for 3 years (CROs or Pharma Industry)
• 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 Contract Research Organizations (CROs).

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.