What are the responsibilities and job description for the Senior Manager, Clinical Trial Business Operations position at CSL?
Reports to: Associate Director, Clinical Trial Business Operations
Position Summary
The Senior Manager, Clinical Trial Business Operations (CTBO) oversees CRO execution of investigator site budgets, contracts, site payments, and ICF deliverables. This role is also responsible for coordinating clinical trial insurance needs and supporting Sunshine Act/transparency reporting requirements. The Senior Manager ensures operational consistency, manages escalations, and contributes to compliance, quality, and governance activities.
Key Responsibilities
CRO Oversight
Required
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
Position Summary
The Senior Manager, Clinical Trial Business Operations (CTBO) oversees CRO execution of investigator site budgets, contracts, site payments, and ICF deliverables. This role is also responsible for coordinating clinical trial insurance needs and supporting Sunshine Act/transparency reporting requirements. The Senior Manager ensures operational consistency, manages escalations, and contributes to compliance, quality, and governance activities.
Key Responsibilities
CRO Oversight
- Review and oversee CRO work related to budgets, contracts, payments, and ICFs.
- Ensure accuracy, quality, and alignment with internal templates, processes, and parameters.
- Provide operational guidance to CRO teams to ensure consistency across regions and studies.
- Manage escalations exceeding CRO negotiation authority.
- Partner with Clinical Operations, Finance, Legal, and other teams to resolve issues efficiently.
- Document and communicate decisions to support timely study startup.
- Intake and triage insurance requests and required inputs.
- Work with Global Insurance & Risk Management to ensure appropriate coverage.
- Track insurance progress and address issues affecting study activation.
- Collect, validate, and reconcile transparency‑related data.
- Partner with Compliance to ensure accurate, timely reporting.
- Support audit readiness for transparency‑reporting activities.
- Apply and help maintain consistent ways of working with internal stakeholders and CRO partners.
- Maintain audit‑ready records for budgets, contracts, insurance, and ICF decisions.
- Monitor operational KPIs and highlight risks or process‑improvement opportunities.
- Participate in operational reviews and governance forums.
Required
- Bachelor’s degree in Business, Finance, Life Sciences, or related field.
- Minimum 7 years’ experience supporting or overseeing site budgets, site contracts, and site payments within pharma/biotech or CRO environments.
- Experience working within outsourced/CRO operating models.
- Strong analytical, communication, problem‑solving, and organizational skills.
- Ability to work cross‑functionally and manage multiple priorities.
- Experience with ICF processes, clinical trial insurance, and transparency reporting.
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.