Associate Project Manager
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Job Description
Associate Clinical Research Manager assisting with clinical trials at Thermo Fisher Scientific. Collaborating with project teams and maintaining accuracy of project documents in a fully remote setting.
Responsibilities:
- Actively participate with project team members to meet project needs, projections and deadlines.
- Oversee organization and accuracy of project documents.
- Work with management on understanding departmental needs and improving processes.
- Provide support for the study conduct, working directly with study monitor and study subjects.
- Oversee data entry, source data QC, EDC data entry and EDC query resolution, lab data verification, subject eligibility status review and subject eligibility notification.
- Liaise with Sites to ensure enrolment projections are understood and tracked against actuals, reviewing screen failure rates, protocol deviations, quality, timelines and budget.
Requirements:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years)
- Basic knowledge of Phase I processes and clinical study operations
- Fundamental knowledge of FDA and EMEA regulations and ICH GCP guidelines
- Basic computer skills with working knowledge of Microsoft Office applications
- Time management and multi-tasking skills
- Written and verbal communication skills
- Ability to prioritize workload and adapt to changing study needs
- Ability to act as a liaison between external and internal groups.
Benefits:
- Health insurance
- Retirement plans
- Paid time off
- Remote work options
- Professional development opportunities
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