Kedrion Biopharma Inc. is an international company specializing in the collection and fractionation of blood plasma to produce and distribute plasma-derived therapeutic products. Our therapies help treat and prevent serious diseases, including Hemophilia, Primary Immune System Deficiencies, and Rh-Sensitization.
Kedrion Biopharma Inc. is committed to providing equal employment opportunities to all employees and applicants. We prohibit discrimination and harassment based on race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all employment terms, including recruitment, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Salary ranges are determined based on relevant experience, education, and certifications.
If you require assistance with your employment application or need reasonable accommodations to perform job duties, please contact our Talent Acquisition team at kedtalent@kedrion.com.
Employee Benefits
At Kedrion Biopharma Inc., we believe in taking care of our people. Our benefits package is designed to support your health, happiness, and future, including:
- Health & Wellness – Full medical, dental, and vision coverage
- Financial Security – Life insurance, AD&D, and retirement savings plans
- Work-Life Balance – Paid time off, sick leave, and paid holidays
- Career Growth – Training programs and development opportunities
- Extra Perks – Employee discounts, wellness initiatives, and more!
For specific inquiries please reach out to us
Job Description
Lead complex global studies that bring life-saving therapies to patients worldwide.
At Kedrion Biopharma, every study we conduct contributes to therapies that improve and save lives for people with rare and serious conditions. As a Senior Clinical Studies Manager, you’ll oversee the planning and execution of multi-country, interventional and non-interventional studies. You’ll serve as both strategic leader and hands-on project manager—ensuring timelines, budgets, and data quality standards are met while maintaining full regulatory and GCP compliance.
This is a dynamic role for a seasoned clinical operations professional who thrives in a fast-moving, collaborative environment.
What You’ll Do
- Lead end-to-end study execution — from feasibility and site selection through close-out, ensuring quality, timelines, and budgets are achieved.
- Oversee CROs and vendors, from proposal and contract management to ongoing performance oversight and sponsor visits.
- Manage study budgets — develop forecasts, track spend, reconcile invoices, and identify cost efficiencies.
- Drive patient recruitment and retention, working closely with investigators and internal partners to meet enrollment goals.
- Ensure compliance and audit readiness, maintain study documentation, addressing findings, and supporting regulatory inspections.
- Manage investigational product logistics — oversee sourcing, distribution, reconciliation, and destruction in line with GMP and study plans.
- Identify and mitigate risks, developing proactive strategies to address site and study challenges.
- Prepare, review, and coordinate key documents including protocols, informed consents, investigator brochures, study reports, and submission materials.
- Collaborate cross-functionally with Medical Affairs, Regulatory, Pharmacovigilance, Quality, and other stakeholders to ensure aligned, high-quality delivery.
- Support scientific engagement, including investigator meetings, advisory boards, and relationships with key opinion leaders.
Requirements
- Bachelor’s degree in life sciences or related field; advanced degree preferred.
- 7+ years of clinical research experience, including at least 3 years managing global or complex studies.
- Strong knowledge of ICH-GCP, FDA, and EU regulations.
- Proven success in CRO/vendor oversight and multi-country study management.
- Demonstrated ability to manage complex budgets and timelines.
- Excellent communication, leadership, and organizational skills.
- Ability to travel domestically and internationally as required.
Kedrion Biopharma Inc. participates in E-Verify and provides the federal government with Form I-9 information to confirm employment authorization. For more information, please contact the Department of Homeland Security.