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Senior Clinical Outcomes Assessment Manager

Job Description

Tarrytown, NJ or Basking Ridge, NJ

Responsibilities:

  • Responsible & accountable for the successful delivery of eCOA for one or more clinical research trials with quality and compliance
  • Responsible for reviewing and approving project related eCOA study documentation during the course of the Project Lifecycle
  • Applies eCOA systems expertise on day-to-day activities when issues are escalated
  • Communicates with internal and external stakeholders and escalates risks
  • Provides input into protocol development as it relates to clinical outcomes
  • May participate in creation of eCOA standards
  • Define and support strategy for eCOA migration and COA validation
  • Support Clinical Study Lead with license acquisition
  • Responsible for eCOA and translation vendor selection, in collaboration with study team
  • Oversee eCOA vendor performance at the clinical trial level, including oversight of KPI, performing root cause analysis and identifying corrective actions, and serving as point of escalation for eCOA issues.
  • Uses interpersonal, negotiating, and project management skills to perform the following tasks as related to COA: Project plan development, execution, and change control. Coordinates resolution & risk mitigation of all eCOA systems related issues and end of study vendor deliverables, Risk management planning, Communication planning, information distribution, performance reporting, and project closure.
  • Provides support for problem resolution between eCOA vendors and study team
  • Monitor financial components related to COA and Innovation for each study
  • Collaborate with study team members on medical monitoring plan
  • Collaborate with data management on eCOA data specifications, standards, and transfers
  • Provides training and mentor new staff
  • Apply problem solving strategies to issues and maintain issue tracking documentation to monitor progress and ensure timely resolution to escalations
  • Develop strategy & processes for expansion of eSource modalities to enable data availability in a virtual clinical trial environment
  • Communicates clinical innovations in eSource modalities to stakeholders and broader organization
  • Develops strategy for implementation of innovative clinical trial technologies and disruptive innovations
  • Provide consultation on eCOA modality benefits, risks, costs and process
  • Facilitates and contributes to study level lessons learned
  • Recommends and participates in cross-functional and departmental process improvement initiatives
  • Responsible for direct supervision of staff

Qualifications:

  • Clinical Operations Experience (Clinical Research Associate or Clinical Trial Management Experience
  • Bachelor Degree




About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.



The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.

Job Requirements

 

Job Snapshot

Location US-NJ-Basking Ridge
Employment Type Full-Time
Pay Type Year
Pay Rate $65,000.00 - $75,000.00 /Year
Store Type Pharmaceutical
Other Compensation: 1 Week Accrued PTO and 6 Federal Holidays
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Company Overview

Aerotek

We know that a company’s success starts with its employees. We also know that an individual’s success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek’s people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has become a leader in recruiting and staffing services by building quality relationships that allow us to place quality people in quality jobs. With more than 230 non-franchised offices, Aerotek’s 6,000 internal employees serve more than 300,000 contract employees and 17,000 clients every year. To learn more, visit Aerotek.com. Learn More

Contact Information

US-NJ-Basking Ridge
Lauren Houmis
9738294437
Snapshot
Aerotek
Company:
US-NJ-Basking Ridge
Location:
Full-Time
Employment Type:
Year
Pay Type:
$65,000.00 - $75,000.00 /Year
Pay Rate:
Pharmaceutical
Store Type:

Job Description

Tarrytown, NJ or Basking Ridge, NJ

Responsibilities:

  • Responsible & accountable for the successful delivery of eCOA for one or more clinical research trials with quality and compliance
  • Responsible for reviewing and approving project related eCOA study documentation during the course of the Project Lifecycle
  • Applies eCOA systems expertise on day-to-day activities when issues are escalated
  • Communicates with internal and external stakeholders and escalates risks
  • Provides input into protocol development as it relates to clinical outcomes
  • May participate in creation of eCOA standards
  • Define and support strategy for eCOA migration and COA validation
  • Support Clinical Study Lead with license acquisition
  • Responsible for eCOA and translation vendor selection, in collaboration with study team
  • Oversee eCOA vendor performance at the clinical trial level, including oversight of KPI, performing root cause analysis and identifying corrective actions, and serving as point of escalation for eCOA issues.
  • Uses interpersonal, negotiating, and project management skills to perform the following tasks as related to COA: Project plan development, execution, and change control. Coordinates resolution & risk mitigation of all eCOA systems related issues and end of study vendor deliverables, Risk management planning, Communication planning, information distribution, performance reporting, and project closure.
  • Provides support for problem resolution between eCOA vendors and study team
  • Monitor financial components related to COA and Innovation for each study
  • Collaborate with study team members on medical monitoring plan
  • Collaborate with data management on eCOA data specifications, standards, and transfers
  • Provides training and mentor new staff
  • Apply problem solving strategies to issues and maintain issue tracking documentation to monitor progress and ensure timely resolution to escalations
  • Develop strategy & processes for expansion of eSource modalities to enable data availability in a virtual clinical trial environment
  • Communicates clinical innovations in eSource modalities to stakeholders and broader organization
  • Develops strategy for implementation of innovative clinical trial technologies and disruptive innovations
  • Provide consultation on eCOA modality benefits, risks, costs and process
  • Facilitates and contributes to study level lessons learned
  • Recommends and participates in cross-functional and departmental process improvement initiatives
  • Responsible for direct supervision of staff

Qualifications:

  • Clinical Operations Experience (Clinical Research Associate or Clinical Trial Management Experience
  • Bachelor Degree




About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.



The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.

Job Requirements

 
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