Jobs at Parexel
We know just how important it is to put people first. It's with that human touch that we've played a part in nearly all of the top 50 treatments on the market. And every day, we're focused on working with industry leaders to bring life-changing healthcare to patients across the globe. Whether you join our Clinical, Consulting, Biotech, Functional Service Provider (FSP), or other teams, we're doing it With Heart ™.
Study Team AssociateJob ID R0000003348 China, Remote
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.
Study Team Associate (FSP)
Parexel FSP is currently seeking Study Team Associate in Beijing
Working as a Study Team Associate at Parexel FSP offers tremendous long-term job security and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50.
Our Study Team Associate work closely with the Project Leader and Functional Leads on project management tasks during the entire project lifecycle contributing to achievement of study deliverables.
Some Specifics About This Advertised Role
- Complete the delegated tasks under the guidance from STL.
- Expected to work on the tasks assigned in less complicated clinical trials independently.
- Lead the set-up of electronic Trial Master Files(eTMF)system Clinical Trial Management System.
- (CTMS). And keep the information updated during course of the study per requirement of the International Conference of Harmonization Guidelines for Good Clinical Practice(ICH/GCP)and SOP.
- Create and maintain the communication platforms (MS Team, SPOL Group email list etc.,) for the whole study team.
- Control the access of systems deployed to a specific study, include but not limited to IxRED, CTMS and eTMF.
- Support clinical trial registration and disclosure on public portal according to the requirement of regulatory authorities.
- Involved in the submission package preparation (including HGR Submission) by working closely with STL CRAs and functional stakeholders.
- Contribute to the clinical trial documents development such as study protocol, ICF, study results report and management plan per STL assignment.
- Responsible for overall TMF library healthy status. Guide study team members (functionals and CRAs) on the eTMF/paper TMF documents transfer & archival and lead Quality Check (QC) per TMF Plan..
- Contribute to the finance related activities such as contract sign-off I&PO set-up, invoice process budget tracker maintenance and reconciliation, including sites and third-party vendors.
- Support goods purchase, document delivery, devices shipment and recycle during the conduct of clinical trial.
- Coordinate and arrange the internal and external meetings, include but not limited to study team meetings vendor defense meetings, investigator meetings committee review meetings. And take meeting minutes/record if necessary.
- Compile and maintain the clinical trial related lists and logs, include but not limited to study document.
- version tracker decision &issue &risk log, study contact list Q&A log, vendor & system list, study specific training log.
- Draft and distribute the newsletters/communication letters/presentation materials to internal and externa stakeholders.
- Complete delegated tasks during the audit and inspection by regulatory authorities.
Here are a few requirements specific to this role:
- Educational Background Bachelor’s degree or above (life science preferred) or certification in a related allied health profession (i.e., nursing, medical or laboratory technology) from an appropriately accredited institution Working Experiences and Competencies.
- Proven organizational and presentation skills.
- Ability to manage multiple tasks and meticulous attention to detail.
- Quick learner, good team player.
- Excellent written and verbal communication skills.
- Good written and spoken English.
- Computer Proficiency: ability to handle daily work via Microsoft Word, Excel, PowerPoint and Outlook, etc.
- Good knowledge of ICH-GCP, 1-year Experience as CTA, CRC, or other roles in the clinical trials is preferable.
Recently Viewed Jobs
You have not recently viewed any jobsView all jobs