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RTSM Specialist

REMOTE, NC 27560

Posted: 01/31/2023 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 542905 Is job remote?: Yes Country: United States

Job Description

SUMMARY:    
Manages the successful implementation of assigned RTSM systems or amendments in accordance with the client’s requirements, within the time and cost frameworks agreed upon and to company standards.

RESPONSIBILITIES:
Tasks may include but are not limited to: •    Provide project management oversight from award to RTSM decommissioning, including oversight and accountability of deliverables and timelines and completion of work to company SOP standards
•    Communicates information on applicable RTSM project activities to stakeholders, including internal and sponsor study teams. Serves as the escalation point of contact for all RTSM assigned study-related project issues
•    Overall accountability for coordination and timely delivery of RTSM project communications including study status reports, meeting agendas and minutes and scheduling project calls
•    Willingness to travel and attend Investigator Meetings or other types of project related meetings when required
•    Responsible for overall RTSM project budget and ensuring accurate vendor work orders for assigned studies
•    Responsible for overall RTSM study design, as well as writing or reviewing and approving User Requirements Specification (URS)
•    Prepare, review and approve site and support materials as well as helpdesk documentation, when required
•    Perform financial review and budget management, including review 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 2 years prior RTSM experience
•    Minimum 1 year prior project management experience
•    Minimum of 5 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

  Target Pay Rate Range: $60-80/hr. Salary will be commensurate with experience 
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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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