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 (e.g. start-up, maintenance and close-out). Ensure work is conducted in line with standard operating procedures, policies and good practices.
Study Setup and Planning:
- Support the Project Manager by attending meetings, preparing minutes and action logs, preparing protocol-specific laboratory instructions documents.
- Under supervision of the Project Manager oversee setup of protocol specific Laboratory Centralized Monitoring requirements
Study Activity Monitoring and Closeout:
- Perform routine tasks across assigned studies including site loading, Investigator Portal access, kit shipments, monitoring day-to-day study performance, overseeing Laboratory Centralized Monitoring.
- Work with internal and external teams to manage timely resolution of queries and protocol questions, issues and escalations
- Use status reports, monitoring tools and outputs to pro-actively identify trends and provide feedback to internal and external teams on performance of Investigator sites and company services.
- Support the Project Manager with administrative study tasks
- Provide input into monitoring plans & reports, and protocol-specific materials. Assist with document quality control reviews.
- Perform delegated Project Manager tasks commensurate with experience and training.
- May perform Sample Management activity oversight and monitoring
- Coordinate and communicate with relevant stakeholders, including leading Customer communications and activities during any times when the Project Manager is absent. Oversee Project Close-out Meetings
Initiatives and Training Activities:
- May represent company at internal and external meetings, participate in external and internal audits/inspections.
- As required will support study training with sites, CRAs and customers, including representing the company at Investigator meetings and / or client meetings.
- Conduct Project launch meetings or other meetings on behalf of the Project Manager as needed
- Process Improvements and Special Assignments:
- Develop and present information to internal and external audiences.
- Mentor and assist in training of more junior staff.
- Provide input into internal Process Improvement projects and SOP revisions. Provide support in completing ad hoc and high priority tasks
- Ensure outputs are delivered in line with organizational standards, protocol specific requirements and Customer expectations
Minimum Required Education and Experience
- High School Diploma or equivalent Bachelor’s Degree – preferred
- Bachelor’s Degree Life sciences
- 1-3 years’ relevant experience . Equivalent combination of education, training and experience. 1 year relevant experience in the Clinical, Medical or Healthcare industry preferred.
Required Knowledge, Skills and Abilities
- Strong interpersonal, communication, organizational, and time management skills.
- Must be able to comply with all applicable standards as required by the company.
- Demonstrated ability to handle multiple competing priorities.
- Utilize resources effectively.
- Demonstrated ability of critical thinking and problem solving.
- Strong written and verbal communication skills including good command of English language. In certain geographies where communication in local language is desired (e.g. Japan, China), excellent command of local language with reasonable proficiency in English preferred.
- Computer proficiency in word processing, presentation and spreadsheet applications.
- Demonstrated ability to work in a fast-paced, high stress environment highly desirable.
- Ability to establish and maintain effective working relationships with coworkers and managers.