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Stellenbeschreibung

For our Legal Partner department in Marburg, we are looking for a

Senior Project Manager - Legal Clinical Contracts (m/w/x) - R-224531
Fulltime / permanent / non-tariff (level 7)

The future position holder is accountable for the successful and timely negotiation and execution of all contracts associated with the CSL clinical studies assigned to him/her. S/he 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 him/her, 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. The Legal Clinical Contracts Project Manager will oversee the work undertaken by the clinical contracts specialist team (CCST), ensuring that specified Service Level Agreements (SLA) for the studies assigned to her/him are met, issues are escalated and resolved, and quality standards are adhered to. The Legal Clinical Contracts Project Manager will be responsible for driving continuous improvement and innovation of clinical contracting processes and templates.

The Role

• Design and develop a contracting plan for each clinical study assigned to him/her, in collaboration with CDO, having regard to the level of risk associated with the study, the volume of contracts required and the appliable 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 him/her, 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 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.

Qualification

• Bachelor’s degree or equivalent foreign degree required.
• Minimum of 8 years’ relevant experience in pharmaceutical industry engaged in contract negotiation and contract management.
• Familiarity with clinical development laws and regulations. Experience in international contracting as well as health care regulations (including fraud and abuse, anti-kickback, and FDA) are highly desirable.
• Drafting and negotiation skills required, as well as ability to produce quality work under pressure while balancing multiple priorities.
• Strong communication, analytical, project management, problem solving, interpersonal, and teamwork skills are required.

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Über CSL Behring
CSL Behring ist ein weltweit führendes Unternehmen, das hochwertige Therapeutika für Menschen mit seltenen und ernsten Krankheiten entwickelt und vertreibt. Mit unseren Medikamenten für die Therapiegebiete Immunologie, Hämatologie, Herz-Kreislauf und Stoffwechsel, Atemwegserkrankungen und Transplantationsmedizin halten wir unser Versprechen, die Lebensqualität von Patienten in mehr als 100 Ländern zu verbessern. Erfahren Sie mehr über CSL Behring.

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