Remote Regulatory Startup Manager

Fred Hutch; Seattle (WA); A distancia; USD 99.000 - 157.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical benefits

Dental

FSA

Life insurance

Disability insurance

Retirement plan

Family support

Employee assistance program

Onsite health clinic

Tuition reimbursement

Paid vacation

Paid sick leave

Paid holidays

Paid parental leave

Descripción de la vacante

Fred Hutchinson Cancer Center is seeking a remote Startup Regulatory Operations Manager to oversee regulatory startup activities, sponsor and investigator coordination, and ensure timely study activations with strong GCP compliance. The role partners with investigators, sponsors, IRBs, CROs and internal stakeholders to maintain inspection readiness and operational excellence.

The candidate will lead regulatory processes, provide staff coaching, and drive scalable startup workflows while aligning

Formación

• Bachelor's degree or equivalent combination of education and experience.
• 5+ years of clinical research experience with regulatory operations experience.
• 2+ years of leadership or supervisory experience.
• Experience supporting regulatory submissions and study startup activities.
• Experience working with IRBs, sponsors, CROs, FDA regulations and GCP requirements.
• Strong project management and organizational skills.
• Excellent verbal and written communication skills.
• Ability to interpret clinical protocols and regulatory guidance documents.
• Ability to manage multiple studies and competing priorities within aggressive timelines.

Responsabilidades

• Lead regulatory startup and activation for a portfolio of studies, coordinating documentation, approvals, training, system access and cross-functional activities.
• Ensure regulatory compliance through review of protocols, informed consents, regulatory files and essential documents; support audits and inspections.

Conocimientos

Regulatory operations

Leadership

Project management

Verbal & written communication

Clinical protocols

Attention to detail

Problem solving

Multi-study management

IRBs & FDA

Educación

Bachelor's degree

Herramientas

Florence eBinders

Veeva

CTMS

REDCap

Descripción del empleo

Fred Hutchinson Cancer Center is seeking a remote Startup Regulatory Operations Manager to oversee regulatory startup activities, sponsor and investigator coordination, and ensure timely study activations with strong GCP compliance. The role partners with investigators, sponsors, IRBs, CROs and internal stakeholders to maintain inspection readiness and operational excellence.

The candidate will lead regulatory processes, provide staff coaching, and drive scalable startup workflows while aligning