Associate Director, Senior Clinical Program Manager

Company: CSL Behring
Location: King Of Prussia
Posted on: May 28, 2023

Job Description:

The Opportunity
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 Associate Director, Senior Clinical Program Manager? The job can be located at any of our CSL locations. This is a hybrid position. You will report to the Senior Director, Clinical Portfolio Execution
As the Associate Director, Senior Clinical Program Manager (Senior CPM) you will develop the operational strategy for a clinical program and ensure the on-time delivery of a clinical program and remain within budget for an assigned Therapeutic Area. You will be responsible for clinical operational planning activities and lead program executions. The Senior CPM manages two or more studies/or products and may take on additional responsibilities as defined by the Therapeutic Area Lead as dictated by project size and complexity. You will lead overall clinical project management, lead the study execution team (SET) and coordinates study execution at the global level. You will oversee the program/study level outsourcing, take preventive/corrective action(s) to address study/program level issues. You will manage/mentor Clinical Study Managers (CSMs) and Clinical Trial Assistants (CTAs).
The Role

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  Develop overall feasibility concept and enrollment plan with input from site management team ---
  
  
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  Ensure regulatory compliance and GCP compliance
  
  
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  Responsible for oversight of TMF with periodic audits
  
  
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  Lead vendor selection and management including issue escalation
  
  
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  Collaborate with CTS team to plan IMP and non-IMP supplies
  
  
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  Ensure monitoring plan is developed and performed in collaboration with COMs
  
  
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  Develop proactive strategy and corrective action plan to address study issues in collaboration with SET and COMs
  
  
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  Facilitate study close out activities through completion of Clinical Study Report 2
  
  
  Your experience
  
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    Bachelor degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area
    
    
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    10+ years' project management of Phase I-III clinical research experience within the pharmaceutical industry.
    
    
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    Understanding of the drug development process, and specifically, each step within the clinical trial process.
    
    
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    Experience in overseeing global clinical trials (pharmaceutical or research institute).
    
    
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    Knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process.
    
    
    BENEFITS
    
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      Medical, Dental Vision
      
      
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      401K
      
      
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      Paid time Off
      
      
      #LI-Hybrid
      Our Benefits
      We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care (https://www.cslbehring.com/careers/how-we-care-for-you-at-csl) at CSL.
      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 (https://www.cslbehring.com/our-company) .
      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 (https://www.cslbehring.com/careers/diversity-and-inclusion) at CSL.
      Do work that matters at CSL Behring!
      R-201564
      CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. https://www.cslbehring.com/careers/eeo-statement

Keywords: CSL Behring, Philadelphia , Associate Director, Senior Clinical Program Manager, Executive , King Of Prussia, Pennsylvania