Discover Impactful Work:
- Provides administrative and technical support.
- Supports audit readiness by ensuring files are reviewed according to SOP and department guidance documents.
- Aids in developing the critical path for site activation within assigned projects.
- May use local knowledge, organization systems, external site lists, and sponsor directives to develop and review site lists for feasibility activities.
A Day in the Life:
- Perform department, internal, country, and investigator file reviews, and document findings in appropriate systems.
- Ensure tasks are performed on time, within budget, and to a high-quality standard. Communicate any risks to project leads.
- Provide system support (i.e., Activate & eTMF) and ensure system databases are current.
- Perform administrative tasks on assigned trials, including processing documents, performing (e)TMF reviews, and distributing communications.
- Support scheduling of client/internal meetings.
- Review and track local regulatory documents.
- Maintain vendor trackers.
- Support start-up team in regulatory submissions.
- Work directly with sites to obtain documents related to site selection.
- Collaborate with teammates to achieve goals for assigned projects.
Keys to Success:
Education:
- Relevant formal academic/vocational qualification. Bachelor’s degree preferred.
Experience:
- Previous experience (6 months to 1 year) that provides the knowledge, skills, and abilities to perform the job.
Knowledge, Skills, Abilities:
- Ability to work in a team or independently as required.
- Flexibility to reprioritize workload to meet changing project timelines.
- Understanding of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs.
- Good English language and grammar skills and proficient local language skills as needed.
- Proficient in MS Office (Word, Excel, and PowerPoint) and ability to master all clinical trial database systems.
- Effective oral and written communication skills.
- Critical judgment and decision-making skills.
- Ability to accurately follow project work instructions.
Benefits:
- Competitive remuneration and annual incentive plan bonus.
- Healthcare and a range of employee benefits.
- Career and development prospects within an innovative, forward-thinking organization.
- Exciting company culture that values integrity, intensity, involvement, and innovation.
