Chiltern is the leading, global mid-sized contract research organization. We listen to client needs to deliver customized clinical development solutions with a team of more than 4,300 working across 47 countries to provide comprehensive, yet flexible and responsive, services. Our specialties include clinical development, Oncology, Devices and Diagnostics, Data, Analytics & Evaluation and Strategic Service Provision.
Chiltern is looking to recruit a Start Up Officer office based in Lisbon to be dedicated to one of our sponsors, a global pharmaceutical company.
The Clinical Trials Application (CTA) Officer function is part of the local Regulatory Affairs team reporting to the local Head of Regulatory Affairs and maintains close functional relations with the Clinical Operations team.
The CTA Officer is responsible to:
- perform correct and timely submissions of Clinical Trial Applications (CTA’s) to the competent authority and ethical committees to ensure that the clinical studies starts in time.
- collect the essential documents and prepare the applicable forms for submissions, in close collaboration with the CML/CRA responsible persons.
- keep tracking of all submitted CTA’s and substantial amendments and to update applicable databases
- act as the contact person for both Regulatory Authorities and sponsors functions with regard to CTA’s and related information.
- keep tracking about applicable laws and regulations related to the submission of clinical trial and maintain the internal Clinical Operations functions properly informed.
- train other colleagues on processes of submission of clinical trials, whenever applicable.
- Scientific degree in the area of health sciences
- At least 2 years of experience in a similar role, preferably with experience in RNEC Platform Submissions
- In-depth knowledge of pharmaceuticals and of local and international clinical trial regulations
- Fluency (oral and written) in both Portuguese and English language
- Effective communication, organizational, and planning skills
- Ability to work independently and to effectively prioritize tasks
- High attention to detail and accuracy