Job description
SUMMARY: Manages the successful continued delivery of assigned live RTSM projects by ensuring high quality execution and work products and by meeting the established project budget and schedule
RESPONSIBILITIES:
Tasks may include but are not limited to:
- Provide project management oversight for amendments, including oversight and accountability of deliverables and timelines and completion of work to Worldwide SOP standards
- Communicates information on applicable RTSM project activities to stakeholders, including internal and sponsor study teams
- Serves as the escalation point of contact during RTSM study maintenance
- Troubleshooting RTSM issues and drives through to resolution
- When applicable, ensure that vendor contracts, budgets, schedules, and deliverables align with the project needs
- Willingness to travel and attend Investigator Meetings or other types of project related meetings when required
- Prepare, review and approve site and support materials as well as helpdesk documentation, when required
- Perform financial review and budget management of Change Orders
- Perform QC checks of manual database edits and other tasks where required
- Request, receive and process/upload draft and final subject and kit schedules and inventory release files where required
- Create User Acceptance Test plans and complete user acceptance testing
- Facilitates sponsor completion of user acceptance testing of system
- Accountability for monitoring study randomization to ensure correct execution
- Perform other duties as assigned
The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
OTHER SKILLS AND ABILITIES:
- Ability to communicate concisely and effectively in both written and spoken English
- Proficient client-facing skills
- Proficient in the use of common office software
- Self-motivated individual who can positively contribute to a team environment
- High attention to detail
- Ability to prioritize and handle multiple projects simultaneously
- Flexible and able to use sound independent judgment and take initiative to assess information
- Able to make effective decisions in a fast-paced, highly dynamic environment
- Able to be creative, adapt to new technologies, concepts and processes, make improvements and solve problems
REQUIREMENTS:
- Educated to degree level in a relevant discipline or able to demonstrate equivalent experience
- Minimum 1 years prior RTSM experience
- Minimum of 2 years experience within CRO /pharma environment
- Contract Research Organization (CRO) or Pharmaceutical experience required
- Familiar with RTSM topics, including RTSM study design, randomization methodologies, and just-in-time drug supply
- Understanding of clinical trials, blinding, patient safety, data integrity and associated regulations
- Proven ability to manage delivery of RTSM solutions deployed in clinical trials
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