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Senior Clinical Operations Assistant

External
Parexel logoParexel · Romania-bucharest-metropolis Center
ContractOn-siteToday
Clinical TrialsComplianceDocumentationExcelGCPVendor Management
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Responsibilities

  • Trial Master File Management
  • Track, scan, code, and organize documents according to the Trial Master File Plan. Maintain quality checks, manage document transfers, and ensure compliance with regulatory requirements.
  • Site Activation & Support
  • Coordinate vendor management for system access (EDC, IVRS), organize investigator site files, and provide comprehensive training support to site staff.
  • Payment Processing
  • Review site contract compliance, process invoices, coordinate with finance teams, and ensure timely and accurate site payments.
  • Clinical Team Support
  • Manage CTMS and study trackers, coordinate document translations, handle courier shipments, track recruitment initiatives, and support data cleaning activities.
  • Essential Skills & Experience:
  • Previous experience in Clinical Trials
  • Strong computer proficiency with CTMS, EDMS, Excel, and Word
  • Knowledge of ICH-GCP guidelines and clinical trial regulations
  • Experience in office management in an international environment
  • Excellent written and verbal communication skills
  • Ability to manage multiple tasks and prioritize effectively
  • High attention to detail and commitment to quality
  • Problem-solving mindset with the ability to work independently
  • Why Join Parexel?
  • Parexel is a leading global clinical research organization with a commitment to advancing clinical research and improving patient outcomes.

Benefits

Work in a collaborative, supportive environment with experienced clinical professionalsFlexible work arrangementsCareer growth opportunities within a global organization.If you are ready to join Parexel's Journey, please apply!Health insuranceFlexible schedule

Additional Information

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 a leading clinical research organization dedicated to advancing life-changing medicines. We work with the world's most innovative companies to bring new treatments to patients who need them. If you're passionate about quality, precision, and making a real difference in clinical research, we want to As a Senior Clinical Operations Assistant (SCOA), you'll be the backbone of our clinical teams, ensuring the smooth execution of clinical trials through meticulous administrative excellence. You'll manage critical documentation, coordinate site activations, process payments, and provide essential support to our clinical teams-all while maintaining the highest standards of quality and compliance. This is a role for someone who thrives on organization, attention to detail, and supporting others to succeed. You may also have the opportunity to lead COA teams on large studies and participate in company-wide initiatives. This role offers flexible working arrangements with a mix of office and home working.


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