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Job Title: Senior Manager, Risk Management

Job Description

The Manager, Risk-Based Quality Management (RBQM) plays a critical cross-functional role in ensuring the quality and compliance of clinical trial execution by leading efforts across all components of RBQM: risk management, central monitoring, and monitoring strategy and oversight. This role is accountable for driving effective risk-based approaches that protect patient safety, ensure data integrity, and enhance operational efficiency. The Manager partners closely with internal teams and CROs to align execution with risk and quality expectations throughout the clinical trial lifecycle.

Responsibilities

+ Plan and lead study- and program-level risk assessments and discussions, ensuring Critical to Quality (CTQ) factors, Quality Tolerance Limits (QTLs), Key Risk Indicators (KRIs), and mitigation actions are consistently applied and tracked.

+ Champion risk-based approaches in protocol de-risking, IQRMP development, and issue management.

+ Contribute to the development of the Clinical Study Report (CSR) related to Risk Management and Quality Tolerance Limits (QTLs).

+ Draft plain language QTL definitions and fully document parameters, thresholds, and justification.

+ Lead and/or oversee centralized monitoring activities, including configuration and review of KRIs, QTLs, and data quality assessments within platforms.

+ Perform user acceptance testing and quality checks on programmed outputs.

+ Evaluate and interpret statistical outputs and risk signals, performing initial root cause analysis and proposing actions.

+ Escalate and present findings and trends, coordinate root cause analysis and remediation with cross-functional stakeholders.

+ Serve as the program-level lead for monitoring oversight, ensuring alignment of CRO/site monitoring practices with RBQM strategy.

+ Develop and implement Monitoring Oversight Plans and risk-adjusted monitoring approaches (on-site, remote, and centralized).

+ Identify performance or compliance trends at the site, study, or vendor level and collaborate with clinical teams to implement corrective actions and quality improvement measures.

+ Collaborate with internal and external cross-functional clinical trial teams to ensure alignment between operational practices and RBQM principles.

+ Deliver training and mentorship on RBQM methodologies, tools, and oversight expectations.

+ Contribute to continuous improvement of RBQM processes, ensuring alignment with evolving regulatory guidance.

+ Ensure audit/inspection readiness by documenting RBQM activities and acting as the RBQM SME during audits/inspections.

+ Promote a proactive, quality-by-design mindset across study teams.

Essential Skills

+ Bachelor’s degree in life sciences, healthcare, or related field or equivalent work experience required; Advanced degree preferred.

+ A minimum of 5 years of clinical research experience, including at least 2 years of risk management, central monitoring/data surveillance, and monitoring oversight.

+ Strong understanding of ICH GCP, particularly ICH E6(R2/R3).

+ Familiarity with quality risk management practices (CtQ, QTLs, KRIs, RACT tools).

+ Proficiency with Microsoft Office, CTMS, risk assessment tools, and centralized monitoring platforms.

+ Strong analytical, communication, and organizational skills with a strong attention to detail.

Additional Skills & Qualifications

+ Oncology experience preferred.

+ Ability to travel - 10-15%

Work Environment

The position requires working EST business hours. The work involves collaboration with internal and external cross-functional clinical trial teams.

Job Type & Location

This is a Contract position based out of Cambridge, MA.

Pay and Benefits

The pay range for this position is $85.00 - $95.00/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)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Dec 3, 2025.

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 due to a disability, please email [email protected] (%[email protected]) for other accommodation options.