Hybrid Operations Research Specialist

at OneTrust

• Job title: Operations Research Specialist
• Job type: Full Time
• Experience level: Junior, Mid level
• Salary: $94,000 - $151,800 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Titusville, United States

About the role

• Operations Related Research Activities Specialist executing pharmacovigilance compliance oversight for market research and patient support programs. Collaborating with stakeholders to ensure compliance and improve processes.

Responsibilities

• 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