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Sr. Project Manager, Clinical Contracts

CSL Behring
Posted Jan 25
Full Time
RemotePennsylvania

The Opportunity:

Reporting to the Global Lead, Clinical Contracting, there are two (2) Sr. Project Manager, Clinical Contracts openings. In this role, you will be accountable for the successful and timely negotiation and execution of all contracts associated with the CSL clinical studies assigned to you. You will act as the primary business partner for the Clinical Development Organization (CDO), and will collaborate closely with CDO by developing the contracting plan for each clinical study assigned to you, participating as a core member of the Study Execution Team (SET) and any other working groups, advising on best practice, and supporting site selection and activation. You will oversee the work undertaken by the clinical contracts specialist team (CCST), ensuring that specified Service Level Agreements (SLA) for the studies assigned to you are met, issues are escalated and resolved and quality standards are adhered to. You will be responsible for driving continuous improvement and innovation of clinical contracting processes and templates. This is a hybrid role, which requires some onsite work.  #LI-hybrid

 

The Role:

  • Design and develop a contracting plan for each clinical study assigned to you, in collaboration with CDO, having regard to the level of risk associated with the study, the volume of contracts required and the applicable study timelines.
  • Support site selection and activation activities, by advising on contracting requirements in each jurisdiction, and associated risks and potential impacts to timelines. Responsible for drafting and reviewing other documents necessary to support study start-up activities for assigned studies, including Country Level ICFs, LOA/POAs and other required documents.
  • Act as the key contracting representative on the SET for the studies assigned to you, monitoring progress of the contracting activities for each study and any evolving contracting requirements, troubleshooting and solving any contract related issues or delays.
  • Oversee the work undertaken by the CCST, ensuring that relevant metrics are tracked and SLAs are met and escalating any issues to the Global Lead, Clinical Contracting.
  • Act as the primary escalation point for any contracting issues raised by the CCST. Negotiate master agreements with sites as needed, and oversee and approve any master agreements negotiated by the CCST.
  • Act as the primary business partner to the Clinical budget/contract manager to oversee site contracting and budget processes and resolve any issues.
  • Implement quality control measures to ensure the CCST work product meets requirements, including through regular monitoring and auditing processes.
  • Drive continuous improvement and innovation of clinical contracting processes and templates, in collaboration with Legal Counsel, Clinical.
  • Interface with internal and external stakeholders in order to identify potential contractual risks and risk mitigation strategies, escalate to Legal Counsel, Clinical, as appropriate.
  • Ensure that established contracting and other Legal processes are adhered to by all internal and external stakeholders.

 

Your Skills and Experience:

  • Bachelor's degree required.
  • Professional contract certifications a plus (e.g., National Contract Management Association, International Association for Contract & Commercial Management, National Federation of Paralegal Associations, etc.).
  • Minimum of 8 years of experience in pharmaceutical industry engaged in contract negotiation and management. Familiarity with clinical development laws and regulations (including GCP/ICH), and health care regulations (including fraud and abuse, anti-kickback, and FDA) highly desirable. Experience in international contracting desirable.
  • Experience in the pharmaceutical, biotech or medical device industry.
  • Strong negotiating and drafting skills.
  • Good communication and stakeholder influencing skills.

 

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!