Role Overview
Provide support to the Project Manager and related team members by performing routine procedures and tasks associated with the day-to-day running of projects throughout the entire study lifecycle (start-up, maintenance and close-out). Ensure work is conducted in line with standard operating procedures, policies and good practices.
Key Responsibilities
- Support the Project Manager in study setup and planning, including attending meetings, preparing minutes and action logs, and preparing protocol-specific laboratory instruction documents. Under supervision, oversee the setup of protocol-specific Laboratory Centralized Monitoring requirements.
- Perform routine tasks across assigned studies such as site loading, Investigator Portal access, kit shipments, monitoring day-to-day study performance, and overseeing Laboratory Centralized Monitoring. Work with internal and external teams to manage timely resolution of queries, protocol questions, issues and escalations.
- Use status reports, monitoring tools and outputs to proactively identify trends and provide feedback to internal and external teams on performance of Investigator sites and company services.
- Coordinate and communicate with relevant stakeholders, including leading customer communications and activities during times when the Project Manager is absent. Oversee project close-out.
- Represent the company at internal and external meetings, participate in external and internal audits/inspections. Support study training with sites, CRAs and customers.
- Ensure outputs are delivered in line with organizational standards, protocol specific requirements and customer expectations.
Qualifications
- Bachelor degree in Pharmaceutical, Biomedical or Biological Science (or related fields).
- Fresh graduates interested in clinical trials/project management are encouraged to apply.
- Strong interpersonal, communication, organizational and time-management skills.
- Demonstrated ability to handle multiple competing priorities.
- Critical thinking and problem-solving skills.
- Strong written and verbal communication skills, including good command of English. Excellent command of local language with reasonable proficiency in English is preferred in certain geographies.
- Computer proficiency in word processing, presentation and spreadsheet applications.
- Ability to work in a fast-paced, high-stress environment is highly desirable.
- Ability to establish and maintain effective working relationships with coworkers and managers.
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