Senior Manager, Risk Quality Management

We are seeking a skilled and experienced Senior Manager to lead Risk Based Quality Management (RBQM) strategies for clinical trials. This role involves overseeing risk management and central monitoring processes, ensuring alignment with study complexity and organizational quality expectations. The successful candidate will work closely with study teams, functional leads, and external partners to drive proactive quality culture and continuous improvement.

• Serve as a Senior integrated RBQM subject matter expert for clinical trials, functional areas, and therapeutic areas.
• Establish and oversee clinical risk management strategies tailored to business needs and study complexities.
• Manage a portfolio of work, including mentorship of Manager-level RBQM team members.
• Lead and facilitate complex cross-functional risk assessments and risk management documentation.
• Provide strategic risk management guidance to study teams, functional leads, and service providers.
• Chair and oversee risk review forums to evaluate and address new or emerging risks.
• Advise on clinical risk management methodologies and promote consistent adoption of RBQM practices.
• Identify cross-study and cross-functional trends to inform risk strategies and process improvements.
• Serve as the Senior central monitoring expert for assigned studies and therapeutic areas.
• Advise on monitoring strategies, including central monitoring and quality analytics.
• Mentor and coach Manager-level RBQM team members on central monitoring strategies and methodologies.
• Connect central monitoring outputs with broader RBQM intelligence.
• Lead or contribute to central monitoring methodology refinement and process development.
• Train study leaders and partners on central monitoring methodologies and risk-based decision-making.
• Influence a proactive quality culture across studies and functional areas.
• Identify trends and opportunities to strengthen RBQM strategy and execution.
• Lead or contribute to high-impact departmental initiatives and process development.
• Mentor Manager-level RBQM team members to build consistency and capability.
• Contribute to audit and inspection readiness by ensuring appropriate documentation of RBQM activities.

• Experience in risk management from the beginning of a study, including protocol review and risk identification.
• Central monitoring oversight experience, especially in managing and holding CROs accountable.
• Ability to independently manage studies from an RBQM standpoint.

• Experience with Cluepoints and Elluminate is preferred but not required.
• Experience in therapeutic areas such as Infectious Disease, Rare Disease, or Oncology is advantageous.
• Experience working with Contract Research Organizations (CROs) is acceptable.

The role offers a sustainable workload with the potential for long-term renewal. The successful candidate will oversee up to approximately 10 studies and will be involved in central monitoring oversight of work performed by the CRO. The work environment foster partnership and collaboration, with opportunities to influence a proactive quality culture.

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

The pay range for this position is $155000.00 - $160000.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

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 Oct 9, 2026.

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