CTA Submissions Manager
- Home Counties
- Contract
- Drug Safety / Pharmacovigilance
This vacancy has now expired
This will be for a period or around 6 months with a view to be remotely based after the initial settling in period.
This position is responsible for managing Clinical Trial Applications submission activities for assigned clinical trials - Phase 1 - 4 - mainly Pulmonary Hypertension.
Candidates looking to be selected for this position will need to have experience in regulatory CTA submission regulations and the requirements will be, to be responsible for the execution of the global CTA submission strategy, as well as the quality and completeness of the CTA regulatory submissions for Clinical Trials
We are offering a highly competitive hourly rate for this position, plus the opportunity to work within an established and fun team.
Responsibilities:
- The Regulatory Clinical Trial Application submission manager will ensure that the required regulatory intelligence is in place to comply with country-specific requirements and will lead a cross-functional team
- The CTA submission manager will either submit the CTAs directly to Health Authorities, or facilitate the CTA submission by local personnel in a given country.
- The CTA submission manager is responsible for interactions with Health Authorities, and will be the primary contact point with regulatory authorities for communications relating to direct submissions of CTAs.
- The CTA submission manager manages the Output Protection Process for assigned trials and ensures that key events related to the regulatory aspects of clinical trials are tracked in the company-own tracking system.
If you feel this is the ideal role for you and would like to work for this fantastic company, then please apply now!
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
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We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
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