CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.
With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions.
Could you be our next Lead Clinical Site Ambassador? The job is located in the King of Prussia PA. This is a hybrid position. You will report to the Regional Head, Site Partnerships.
Responsibilities:
- You will be responsible for the overall Site Management activities of the CSAs of one or more Clinical Studies and the overall study site relationship status for the region(s) assigned.
- Ensure all activities that support the TA model are planned following the TA strategy, appropriate international regulatory standards, and within the agreed timeframe and budget.
- Develops study level documents and training material aligned with the study strategy (e.g. Monitoring Plan, Annotated Trip Reports, CSA and Site Training)
- Member of the Study Execution Team (SET) responsible for the execution of the clinical trial(s) at the site level.
- Leads CSA activities through site identification, selection, start-up, activation, maintenance, and closure
- Manages the performance and development of CSAs that report to them, if applicable
- Reviews monitoring visit reports and tracks actual to projected variables and parameters related to CSA and site activities
- Collaborates with internal and external cross-functional stakeholders to ensure translation of the clinical development strategy and clinical protocol into operational deliverables
Qualifications:
- Bachelor's degree , or equivalent, in Science related discipline
- 7+ years experience working in a Clinical Operations environment is required.
- Global Clinical Operations experience is important.
- Experience should include on-site monitoring and clinical research experience or education.
- Global Clinical Operations experience, clinical trial system experience and ICH GCP knowledge is important
- Up to 20% travel is required
BENEFITS
- Medical, Dental Vision
- 401K
- Paid time Off
#LI-Hybrid
Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what’s available to you as a CSL employee.
About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
We want CSL to reflect the world around us
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Behring!
