When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Parexel is currently seeking an experienced Study start up administrator to join us in Czechia, Romania, Serbia, Hungary and Ukraine, you be assigned to one of our key sponsors in the region.
Working as an Initiation CRA, you’ll be responsible for ensuring the completeness of Site Essential Document Packages as well as the Site Regulatory Packages. Reviewing essential documents, tracking and ensuring all files are in place in the eTMF.
Some specifics about this advertised role
- Dedicated to one client.
- Gathers all documents required for the purposes of enabling Site Initiation; includes the compilation of documents from multiple internal stakeholders and supporting functions to then distribute to the site in a structured and time sensitive manner.
- Review investigator site essential documentation packages from CROs per process and sample as needed
- May collaborate directly with sites regarding collection of documents and IRB timelines for site activation and ensure that relevant documents are uploaded into the eTMF.
- May represent Site Start up on cross-functional study team (s) and/or sub-team(s); Attends Kick Off meetings to present SSU Roles and Responsibilities
Here are a few requirements specific to this advertised role.
- 3 years in essential or regulatory document management in Pharmaceutical /CRO industry, understanding of clinical study start up requirements and working knowledge of relevant documentation.
- Strong familiarity with EUCTD/R and Federal Code of Regulations
- Familiarity with Veeva Vault Clinical for CTMS and eTMF use
- Excellent verbal and written influencing and training/mentoring skills, in local language and English
- Strong coordination and organizational skills
Top Skills
What We Do
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com.
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