Study Coordinator, RTSM Support - United States
- Assist with project support and administration for projects utilizing company RTSM technology by:
- Understanding and effectively utilizing the primary RTSM system version used by the client.
- Utilizing other RTSM support tools to manage and maintain on-going clinical studies.
- Supporting multiple studies and customers in various stages of the study life-cycle.
- Working closely with the RTSM Leads (study maintenance managers) on assigned study support tasks to meet project/task timelines.
- Keeping RTSM Lead (maintenance manager) advised of task status and escalating as appropriate.
- Serving as additional point of contact to sponsors, sponsor vendors, sites, etc.
- Resolving or escalating study support issues in accordance with all documented processes, work instructions or standard operating procedures.
- Attending and participating in required sponsor or study maintenance meetings.
- Coordinating, hosting, or recording minutes for internal and external meetings.
- Creating, updating and maintaining study specific documents, including but not limited to, study specific project plans, user guides, and data and parameter change plans into a single version-controlled source.
- Maintaining study specific binder with current versions of study maintenance documents.
- Collecting, documenting, and performing customer requested parameter and data changes in alignment with documented processes.
- Facilitating translations of RTSM system and associated documentation.
- Working exclusively with Unblinding (confidential) data and information.
- Protecting blinded information at all times during both verbal and written communication.
- Creating and maintaining metrics as needed.
- Responding to tasks from the Solutions Engineer (study implementation manager) for study changes and upgrades.
- Keeping manager advised of current issues.
- Providing urgent study specific support after business hours as needed.
- Contributes to overall department communication, cooperation and efficiency by:
- Suggesting improvements to work processes that enhance the quality of team/client support and improve efficiency.
- Creating, implementing and presenting training materials and tools for both internal and external teams.
- Preparing for and participating in internal/external audits and investigations.
- Participating in the creation of audit response documentation as part of Quality Investigations.
- Continuously improving understanding of business and client processes.
- Travel: 5-20%
- Lifting: 0-25lbs
- Other: Computer work for long periods of time
- Bachelor’s degree preferred
Additional skill set:
- Conduct reflects integrity, honesty, and responsibility for decisions and behavior
- Able to handle difficult and stressful situations with professionalism, initiative, logic and good judgment
- Able to apply procedures across an extensive range of scenarios requiring strong problem solving and investigation skills
- Demonstrated ability to manage time and multiple tasks, effectively prioritize responsibilities, and successfully meet deadlines
- Ability to work independently and in group settings, leveraging relationships for the completion of common goals
- Excellent attention to detail and orientation toward meticulous, well organized work
- Strong interpersonal and communication skills, both verbal and written
- Goal oriented
- Experience managing project timelines is preferred
- 2+ years of experience in customer facing engagements
- 2+ years utilizing Microsoft Office Suite or similar tools
- Working with clinical trials and/or within pharmaceutical environment preferred
- Experience with interactive response technologies, drug supply, randomization strategies, or other clinical trials management methods preferred
- Experience working within regulatory guidelines such as ICH, FDA, EMEA preferred