OneTrust

Operations Research Specialist

OneTrust

full-time

Posted on:

Location Type: Hybrid

Location: Titusville • New Jersey • Pennsylvania • United States

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Salary

💰 $94,000 - $151,800 per year

About the role

  • Responsible to execute the pharmacovigilance compliance oversight process for market research, patient support programs and non-interventional studies
  • Fulfill audit/inspection requests
  • Gather and/or generate key performance and compliance metrics
  • Address compliance issues as appropriate
  • Data Analysis and Visualization: Serve as the primary monitor of RRA metrics and KPIs
  • Collaborate with stakeholders to create and monitor meaningful digital dashboards that enable clear interpretation and data-driven decision making
  • Review and approve Market Research, Patient Support Programs, and/or non-interventional studies program within defined system per documented procedures
  • Make timely decisions to prevent noncompliance or address compliance issues
  • Maintain and compile proper documentation of compliance activities
  • Ensure accurate data within the system to generate key performance and compliance metrics
  • Review compliance reports and other relevant data to inform decision-making on actions that need to be taken to prevent noncompliance and/or resolve issues
  • Development of oversight reports
  • Identify potential compliance risks within the organization and work with management to develop strategies and controls to mitigate those risks
  • Perform reconciliation of safety data against the safety database
  • Liaise with Global Medical Safety Organization and suppliers
  • Support noncompliance process including initiating quality investigations and managing records
  • Manage 3rd party vendor performing manual compliance tasks
  • Collaborate with key functional partners to ensure compliance requirements are met
  • Fulfill inspection and audit requests and/or provide subject matter expertise of the compliance oversight process
  • Support the implementation of process efficiencies and continuous improvements to decrease cycle time and improve quality of data
  • Educate Activity Owners on regulations and policies, providing guidance on compliance-related issues.

Requirements

  • Minimally a Bachelor’s degree in Science, Engineering and Technical subjects
  • Minimum of 2 years of pharma or clinical experience
  • Understanding of relevant regulations, laws, and industry standards
  • Familiar with the compliance requirements and be able to interpret and apply them effectively
  • Ability to manage issues using deductive reasoning, critical analysis skills and systematic approaches
  • Able to analyze data, identify potential compliance risks or noncompliance, and make recommendations based on their findings
  • Ability to think in a clear, decisive manner, remains calm under adverse conditions, and reaches independent, reasoned decisions and solutions when required
  • Organizational and time management skills to prioritize tasks, meet deadlines, and ensure that compliance activities are carried out effectively
  • Able to build positive relationships, demonstrate effective collaboration, and work as part of a team
  • Strong influence and negotiation skills
  • Critical thinking and leadership skills
  • Able to interact with Regulatory Authorities
  • Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers
  • Excellent computer proficiency e.g MS Office, SAP
  • Excellent analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution
  • Must be able to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude.
Benefits
  • Vacation –120 hours per calendar year
  • Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
  • Holiday pay, including Floating Holidays –13 days per calendar year
  • Work, Personal and Family Time - up to 40 hours per calendar year
  • Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
  • Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
  • Caregiver Leave – 80 hours in a 52-week rolling period
  • Volunteer Leave – 32 hours per calendar year
  • Military Spouse Time-Off – 80 hours per calendar year
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
data analysisdata visualizationcompliance oversightaudit managementperformance metricsrisk identificationsafety data reconciliationquality investigationsprocess improvementregulatory compliance
Soft Skills
critical thinkingproblem-solvingorganizational skillstime managementcollaborationinfluence skillsnegotiation skillsleadership skillscommunication skillsdeductive reasoning