- The Manager, Clinical Systems (IRT) will work with a cross-functional team of internal stakeholders (including but not limited to: Clinical Study Management, Supply Chain and Data Management functions) and technology suppliers to support the implementation and maintenance of interactive response technology (IRT) solutions to support a clinical trial. The Manager, Clinical Systems (IRT) will provide technical oversight to ensure that IRT solutions adhere to the study protocol, industry regulations / best practices as well as company policies, procedures and guidelines.
location: Telecommute
job type: Contract
salary: $75.00 - 83.87 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Serve as the champion and consultant for most efficient and effective IRT design as needed per study protocol
- Lead and facilitate system requirements gathering meetings with clinical study teams and IRT supplier contacts
- Design and oversee the development of study-specific IRT technical documents
- Document issues and risks, and implement mitigation plans in partnership with study team and technology supplier PM
- Identify and track study-related technical issues to resolution
- Closely manage project-related timelines and associated activities
qualifications:
Required:
- Doctorate Degree or Master Degree and 2 years of IRT experience or Bachelor Degree and 4-5 years IRT experience, clinical experience OR Associate's degree and 10 years of IRT experience
OR High school diploma/GED and 12 years of IRT experience
- 5+ years focused on IRT experience
- Bachelor's Degree in life science, computer science, engineering, business or related discipline
- 4+ years of experience in clinical operations, clinical supply chain or clinical systems management
- Experience implementing clinical systems, such as IRT and eCOA
- Working knowledge of Good Clinical Practices and FDA regulations governing clinical trial execution
- Detail-oriented and able to manage many projects simultaneously
- Excellent documentation and communication skills
- Meeting management and facilitation skills
- Vendor management experience
- Excellent time management and organization skills in a timeline-driven environment
- Sound problem resolution, judgment, and decision-making abilities
- Work well in a team-based environment with minimal supervision
skills: FDA, Clinical Data Management, GCP (Good Clinical Practice), Clinical Study Design
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
