Global Clinical Lead/Lead CRA, Oncology
- Employer
- Ipsen Biopharmaceuticals, Inc.
- Location
- Cambridge, MA, United States
- Start date
- Nov 8, 2019
View more
- Discipline
- Clinical, Clinical Research, Science/R&D, Research
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Genetown
Job Details
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.
Company
Ipsen (Euronext: IPN; ADR: IPSEY) is a global, biopharmaceutical group focused on innovation and specialty care. The group develops and commercializes innovative medicines in three key therapeutic areas - Oncology, Neuroscience and Rare Diseases. At Ipsen, we focus our resources, investments and energy on discovering, developing and commercializing new therapeutic options to provide hope for patients whose lives are challenged by difficult-to-treat diseases. Ipsen's North American operations and headquarters are located in Cambridge, Massachusetts, where our fully integrated biopharmaceutical team across External Innovation and Partnering, Research & Development (R&D), Manufacturing and Commercial collaborate. Cambridge is home to Ipsen's third global hub, in addition to R&D centers in Paris-Saclay in France and Oxford in the United Kingdom. With additional offices in Basking Ridge, N.J. and Mississauga, Ontario, Ipsen employs approximately 600 people in North America. For more information on Ipsen in North America, please visit www.ipsenus.com or www.ipsen.ca.
- Website
- https://www.ipsenus.com/
- Phone
- 617-679-8500
- Location
-
1 Main Street
Unit 700
Cambridge
MA
02142
United States
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