Job Description
The Clinical Trial Operations Manager serves to support the design and conduct of operational activities related to planning, implementing, executing, and reporting of multicenter clinical trials in accordance with standard operating procedures, Good Clinical Practice, and local and federal regulations. May provide supervision of multiple Clinical Research Data Specialists that ensure data accuracy across participating clinical research sites. Directs long-range strategic planning for the clinical trial, including the setting of goals and objectives. Ensures that goals and milestones remain on track and develops and implements corrective action plans in an effort to improve performance when needed.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Required Skills & Experience
• 5-10 years of Clinical Research experience
• Academic environment experience rather than for profit
• Multicenter trial management (meaning sponsor facing experience)
• Understanding of regulations, IND/IDE trials/regulation exempt trials
• Single/Central IRB experience
• Clinicaltrial.gov registration/reporting experience
• Management of sites
- Conduct feasibility assessments
- Executing sponsor consent forms
Nice to Have Skills & Experience
• Experience with REDCap - Ability to work a query function & monitor data
• FDA knowledge
• Redcap experience – Not building. Ability to work a query function & monitor data
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.