Senior Manager, Risk Based Quality Management

Job Title: Senior Manager, Risk Based Quality Management

Job Description

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.

Responsibilities

• 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.

Essential Skills

• 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.

Additional Skills & Qualifications

• 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.

Work Environment

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 fosters partnership and collaboration, with opportunities to influence a proactive quality culture.

Job Type & Location

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

Pay and Benefits

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)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Oct 16, 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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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 [email protected] 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.