Country Clinical Trials Specialist
- Experience Level
- Experienced (non-manager)
Country Clinical Trials Specialist
Location: Portugal, home-based.
Providing innovative solutions for our clients is what we do. But innovation just for the sake of innovation isn’t why we do it. Side-by-side with our clients, we strive to move drug discovery forward, to help them develop life-saving and life-improving drugs. We help change people’s lives for the better every single day. It’s who we are. And it’s who you could be too.
Working fully embedded within one of our pharmaceutical clients, with the support of PRA right behind you, you’ll be at the heart of our client’s innovation.
As Country Clinical Trials Specialist, you will be dedicated to one of our global pharmaceutical clients; a science-based company with one of the most exciting product pipelines in the industry. This global pharmaceutical client develops breakthrough innovative medicines to improve and extend people’s lives in various therapeutic areas. Working in this way, you will have the opportunity to build your career in a rewarding customer-focused environment that supports creativity, collaboration and performance.
- As the main country contact for country feasibility:
- When applicable within required timelines and with input of local (country or hub) external and internal experts, provide input into study concepts, study protocols, logistics, standard therapy / comparator availability and costs, regulatory landscape coordinating, provide input to local delivery lead for study budget forecasts in the country;
- As the main country contact for set-up and roll-out of the local study team if a study is allocated to the country:
- Support management activities for local study team(s) if required, escalates resourcing needs to ensure efficient study conduct in the country to CSM;
- With support from CSM, communicates and obtains access to the sponsor's systems, identifies training needs, supports training and rolls-out training on processes to local study team(s);
- With input of CSM and local operating company (LOC) where applicable, supports identification, qualification and contracting of investigators sites and the sponsor's preferred / new local vendors (e.g. for translation, local purchases, drug destruction etc.) or leverages CRO preferred vendors, supports CSM with input and execution of vendor oversight plans (where applicable);
- Supports CSM with country data for study budget forecast, accruals, tracking and payments of investigator’s and vendor invoices, supports LOC with financial data for public disclosure or / and tax recoveries (if applicable);
An experienced, ambitious self-starter looking for the opportunity to prove yourself in an embedded role at a top three pharmaceutical company.
Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:
· Prior experience of working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment.
· A working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential, ability to work under Sponsor SOPs & systems
· Good interpersonal skills with ability to build strong internal and external relationships.
· Strong planning & organizational skills, and the ability to work efficiently and effectively in a dynamic environment
· Available and willing to travel as job requires
· You will be educated to degree level in a life science discipline or be a licensed healthcare professional.
Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.