Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
Clinical Trial Execution
- Assist in the management of study budgets including the set up of purchase orders and e-requisitions
- Order, track, and ship study supplies, tools, and/or instruments
- Track and report Regional/Global enrollment data for ongoing clinical studies
- Perform routine study activities per policies/procedures (e.g. Study closeout)
- Participate in shared learning forums
- May assist with other appropriate trial level activities as needed (i.e. coordination of regional and trial project-related meetings, structure of newsletters, uploading minutes to the study collaboration site(s) or eTMFs as appropriate, etc.)
Clinical Trial/Submission Documentation
- Support and partner with CTPM and Clinical Development Manager to oversee maintenance and inspection readiness of study files (e.g. eTMF, study collaboration sites, etc.) including quality reviews (routine and pre-inspection), associated updates, and indexing
- Support backroom for regulatory and mock inspections
- Support collection and review of key information to support submission activities (i.e. collecting and verifying accurate information for financial disclosures/1572 and OSI)
- Establish, maintain and use appropriate team information repositories (e.g., Microsoft Teams, eTMF, etc.) and maintain project team rosters.
- Support filing and archiving processes
Clinical Trial Systems Management
- Accurately input study timelines and other trial level required fields into clinical trial database (IMPACT), monitors and updates fields as study timelines or other information changes, and troubleshoots illogical data
- Assist in producing and distributing project status reports
- Coordinate with Clinical Trial Project Managers and Clinical Development Managers to generate regional-level, trial-level and compound-level milestone and budget reports, IMPACT accuracy and completeness reports, staff capacity reports, and other reports as needed.
Minimum Qualification Requirements:
- Two-year degree or 2 years administrative or technical experience
- Computer proficiency and experience using a variety of software packages (e.g., Microsoft Word, Excel, Power Point, Project)
Highly Desired Skills:
- Strong communication skills; able to communicate clearly and succinctly with team members and leadership
- Demonstrated ability to work effectively cross-culturally as well as across regions/geographies with strong customer service skills
- Strong teamwork and interpersonal skills including demonstrated ability to flex to changing business needs, attention to detail, strong self-management, organizational skills, and problem solving
- Ability to maintain confidentiality
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