Senior Clinical Specialist

EPM Scientific; California; Híbrido; USD 120.000 - 180.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work environment

Descripción de la vacante

EPM Scientific is seeking a Senior Clinical Specialist to support global clinical studies from site start-up to close-out. You will work closely with clinical leadership, investigative sites, and cross-functional teams to ensure studies are delivered with quality, speed, and compliance.

This role is ideal for someone who enjoys being close to study execution, building relationships with sites, and solving operational challenges to make a direct impact on patient-focused clinical research.

Formación

• Experience in clinical research as a CRA/Senior CRA or similar operations role.
• Strong knowledge of GCP, ICH guidelines, on-site monitoring, and site management.
• Experience supporting start-up, enrollment, monitoring, and close-out activities.

Responsabilidades

• Manage and support assigned clinical sites across start-up, monitoring, and close-out.
• Drive site performance, enrollment, and study milestones with Clinical Operations.
• Ensure studies follow protocols, GCP, ICH, and regulatory requirements.
• Oversee TMF/ISF maintenance, product accountability, and study reporting.
• Collaborate with Medical Affairs, Regulatory, Quality, Data Management, and PV.

Conocimientos

CRA/Senior CRA experience

GCP/ICH knowledge

On-site monitoring

Site management

Communication & relationship-building

Descripción del empleo

The Opportunity

This is an opportunity to join a clinical-stage biopharmaceutical company as a Senior Clinical Specialist, supporting the execution of global clinical studies from site start-up through close-out. With an active portfolio and ongoing clinical programs, you'll play a highly visible role partnering with clinical leadership, investigative sites, and cross-functional teams to ensure studies are delivered with quality, speed, and compliance.

This position is ideal for someone who enjoys being close to study execution, building relationships with sites, solving operational challenges, and making a direct impact on patient-focused clinical research.

What You'll Be Doing

• Manage and support assigned clinical sites across study start-up, monitoring, and close-out activities.


• Partner with Clinical Operations and Study Leadership to drive site performance, enrollment, and study milestones.


• Ensure studies are conducted in accordance with protocols, GCP, ICH guidelines, and regulatory requirements.


• Oversee site documentation, TMF/ISF maintenance, investigational product accountability, and study reporting.


• Collaborate with cross-functional teams including Medical Affairs, Regulatory, Quality, Data Management, and Pharmacovigilance.

What You'll Bring

• Experience in clinical research as a CRA, Senior CRA, Clinical Specialist, or similar clinical operations role.


• Strong knowledge of GCP, ICH guidelines, on-site monitoring practices, and site management.


• Experience supporting study start-up, enrollment, monitoring oversight, and close-out activities.


• Ability to work independently while managing multiple priorities in a fast-paced environment.


• Strong communication, relationship-building, and problem-solving skills.

What You'll Get

• The opportunity to work directly with clinical leadership and contribute to high-impact clinical programs.


• Exposure to both operational and strategic aspects of global clinical development.


• A collaborative environment where your input is valued and your work has visible impact.


• Career growth opportunities within an expanding clinical organization.


• Hybrid work environment with the ability to work closely alongside cross-functional teams.

If you have a strong clinical operations foundation and enjoy working directly with sites to drive study success, we'd love to speak with you.