Site Start Up Specialist
vor 1 Woche
Our team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global contract research organization (CRO).
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
Our goal-driven teams combine and deliver start up activities for the clinical trials, collaborating to improve processes, cycle and flexibility. We partner with our sites, businesses and colleagues around the world to decrease startup timelines and exceed expectations.
PPD is currently looking for a Site Start Up Specialist (Country Approval Specialist) who will be home based a in Austria.
In this role, you will:
- Provide local regulatory strategy advice (MoH &/or EC) to internal clients
- Provide project specific local SIA services and coordination of these projects
- May have contact with investigators for submission related activities
- Key-contact at country level for either Ethical or Regulatory submission-related activities
- Coordinate, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation
- May develop country specific Patient Information Sheet/Informed Consent form documents
- May assist with grant budgets(s) and payment schedules negotiations with sites.
- Support the coordination of feasibility activities, as required, in accordance with agreed timelines
- Enter and maintain trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner
- Ensure the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs
- Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided
Required Skills, Qualification and Experience:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Related experience or equivalent combination of education, training, & experience
- Effective oral and written communication skills
- Excellent English and German language skills (at least C1 level)
- Excellent interpersonal skills
- Strong attention to detail and quality of documentation
- Good negotiation, organizational and planning skills
- Good computer skills and the ability to learn appropriate software
- Basic medical/therapeutic area and medical terminology knowledge
- Ability to work in a team environment or independently, under direction, as required
- Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulation
As well as being rewarded a competitive salary, we offer a benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly values a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
LI-Remote #LI-BN1
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