Risk-Based Quality Management Contractor

We are seeking a dedicated Risk-Based Quality Management Contractor to support the implementation and execution of a comprehensive RBQM framework. This role requires alignment with ICH E6(R3), ICH E8(R1), and ICH Q9 principles, contributing to the quality management of clinical trials.

Responsibilities

• Support implementation and execution of the RBQM framework in line with ICH principles.
• Contribute to Critical-to-Quality identification, risk assessments, and ongoing risk review activities.
• Develop, review, and maintain RBQM deliverables such as risk assessments and monitoring strategies.
• Interpret and apply RBQM governance expectations, differentiating between risks, issues, and quality events.
• Oversee CRO activities related to RBQM, ensuring alignment with expectations.
• Support centralized/statistical monitoring activities and the review and interpretation of risk indicators.
• Collaborate with internal teams and CROs to translate monitoring outputs into actionable strategies.
• Facilitate cross-functional discussions on emerging risks and mitigation strategies.
• Ensure alignment between centralized monitoring outputs and on-site/remote monitoring activities.
• Support continuous improvement of RBQM processes, tools, and templates.
• Draft and review SOPs, guidance documents, and training materials related to RBQM.
• Standardize RBQM practices across studies while considering protocol-specific assessments.

• Strong background in Risk-Based Quality Management, Quality Risk Management, or Clinical Trial Operations.
• Solid understanding of clinical trial conduct, lifecycle, and inspection expectations.
• Familiarity with ICH guidelines relevant to RBQM (E6, E8, Q9).
• Experience with KRIs, QTLs, CTQs, and risk assessments in clinical trials.
• Ability to work effectively in a matrixed, cross-functional, and global environment.
• Strong written and verbal communication skills for articulating risks and recommendations.
• Comfortable interpreting data outputs, dashboards, and monitoring summaries.

• Prior experience supporting RBQM within a pharmaceutical company, biotech, or CRO.
• Exposure to centralized/statistical monitoring platforms (e.g., CluePoints, Medidata, IQVIA tools).
• Experience supporting vendor oversight or CRO-delivered monitoring models.
• Inspection preparation or inspection support experience related to quality oversight or monitoring.
• Advanced degree in life sciences, statistics, pharmacy, nursing, or related field (or equivalent experience).

This position allows for 100% remote work; however, candidates must be physically located in an EST state. Success in this role requires a pragmatic and solution-oriented approach, comfort with evolving processes, and the ability to balance detail orientation with operational realities. Independent work is expected while maintaining alignment with RBQM leadership and governance expectations.

Job Type & Location

This is a Contract position based out of Basking Ridge, NJ.

The pay range for this position is $65.00 - $70.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully remote position.

This position is anticipated to close on Jun 5, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard 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 email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: 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.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

Salary : $65 - $70