Remote RBQM Senior Manager – Quality Risk Oversight

Actalent; Cambridge (MA); Remoto; USD 155.000 - 160.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, dental & vision

401(k) Retirement Plan

Paid time off

Descrizione del lavoro

Actalent is seeking a Senior Manager to lead RBQM strategies for clinical trials, overseeing risk management and central monitoring to align with study complexity and quality expectations. You will work with study teams, functional leads, and external partners to drive proactive quality culture and continuous improvement.

The role involves mentoring RBQM team members, guiding cross-study risk initiatives, and contributing to audit readiness, with a remote-friendly setup based out of Cambridge,

Competenze

• 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.

Mansioni

• 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.
• 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.

Conoscenze

RBQM

Risk management

Central monitoring

Study leadership

Strumenti

Cluepoints

Elluminate

Descrizione del lavoro

Actalent is seeking a Senior Manager to lead RBQM strategies for clinical trials, overseeing risk management and central monitoring to align with study complexity and quality expectations. You will work with study teams, functional leads, and external partners to drive proactive quality culture and continuous improvement.

The role involves mentoring RBQM team members, guiding cross-study risk initiatives, and contributing to audit readiness, with a remote-friendly setup based out of Cambridge,