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.
Key Accountabilities:
Study Team Supporting
- TMF: Set up and maintain the site level TF/eTMF, coordinate on document collection, uploading into SharePoint (SP)/eTMF, check the document completeness, and provide TMF/eTMF quality control (QC) if required.
- EC Submission: Coordinate on EC submission dossier, site start-up preparation, and EC fee application and tracking.
- Process protocol amendments; may include IF updates.
- Tracker/Metrics Report: Collect and update study trackers/metrics report for site level if needed.
- Site Contract and Payment: Assist in contract signature process; assist in site level payment initiative and payment and invoice tracking.
- Site Materials and Equipment: Distribute site materials and equipment, document printing, shipment, and other administrative work.
- Administrative: Business and department office administration support if required.
- To undertake other reasonably related duties as may be assigned from time to time, as appropriate for level of experience.
Compliance with Parexel standards
- Comply with required training curriculum.
- Complete timesheets accurately as required.
- Submit expense reports as required.
- Update CV as required.
- Maintain a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements
Skills:
- Proven organizational and presentation skills.
- Ability to manage multiple tasks and meticulous attention to detail.
- Agile & quick learner, good team player
- Willingness and ability to train others on study administration procedures.
- 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.
Knowledge and Experience:
- 0.5 years of clinical trial experience in the pharmaceutical of CRO industry. Exceptions may be considered based on level of training and mentoring available.
- Read, write, and speak fluent English; fluent in host country language may be required.
- Excellent organizational skills and ability to prioritize and multitask.
- 2 or more years of clinical trial experience in the pharmaceutical or CRO industry.
Education:
- Bachelor's degree or above in life sciences, English, and management.
Originally posted on Himalayas
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