CSP Oversight Specialist

Accountabilities:

- Maintain CSP qualification, requalification, and ongoing oversight programs using a structured, risk-based approach.

- Conduct qualification and requalification activities for a broad range of clinical service providers, including CROs, laboratories, imaging providers, ethics committees, and computer systems or software vendors.

- Identify, assess, and mitigate risks associated with the use and performance of CSPs.

- Provide CQA oversight of service providers and intervene when performance or compliance does not meet expectations.

- Manage quality events, non-compliances, CAPAs, serious breaches, and CSP corrective action requests (CSPCARs), ensuring appropriate follow-up and resolution.

- Support the negotiation, implementation, and ongoing management of quality agreements with external service providers.

- Represent the quality function in study management team meetings and CSP meetings, providing relevant quality and compliance guidance.

- Apply company policies, procedures, business ethics, and quality standards consistently while taking ownership of assigned responsibilities and additional duties as required.

- Travel periodically to support business and CSP oversight activities, with travel of up to 20%.

Requirements

- Bachelor’s degree in life sciences or equivalent professional experience.

- 5+ years of overall experience in GCP, Quality Assurance, or a closely related clinical quality discipline.

- At least 2 years of experience specifically focused on clinical service provider oversight.

- Practical knowledge of CSP qualification and requalification, risk assessment, quality events, CAPAs, non-compliances, and GCP requirements.

- Strong written, verbal, and interpersonal communication skills, with the ability to work diplomatically and build productive partnerships across departments.

- Exceptional organizational, critical-thinking, prioritization, analytical, troubleshooting, and problem-solving abilities.

- Ability to manage multiple priorities simultaneously, exercise sound judgment and discretion, and consistently meet deadlines in a fast-paced environment.

- Proficiency with relevant computer systems and Microsoft Office applications.

- Comfortable working collaboratively with internal stakeholders and external service providers in complex and continuously changing environments.

- Ability to perform the physical and communication activities associated with a remote office role, including prolonged periods of sitting or standing, extensive computer and reading work, and repetitive hand and wrist movements.

Benefits

- Annual base salary range of $110,000–$120,000 USD .

- Remote work environment with standard office equipment and computer-based working arrangements.

- Opportunity to contribute to a global CQA function within a highly regulated clinical development environment.

- Meaningful ownership of CSP qualification, risk management, quality oversight, and compliance activities.

- Cross-functional collaboration with study management teams and external clinical service providers.

- Professional exposure to GCP compliance, clinical quality systems, CAPAs, quality agreements, and risk-based oversight.

- Travel opportunities of up to 20% as required by the role.

- Compensation may vary based on factors including primary work location, role complexity and responsibilities, education, experience, and relevant skills.

How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
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