Clinical Partnership manager

1 mese fa

Italia Chiesi Farmaceutici S.p.A. Tempo pieno
Business Area: R&D, Pharmacovigilance & Regulatory Affairs Contract Type: Permanent Parma or Chiesi Affiliates in , IT Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact. We believe our differences make us stronger. Chiesi Research & Development Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management. Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden), Toronto (Canada) and Shanghai (China). Within Global Clinical Operations and reporting to the Clinical Partnerships & Operations Excellence Lead, the Clinical Partnership Manager will play a key role in enabling, fostering and optimizing the governance and operational model of strategic partnerships with CROs, working closely with clinical study teams, category managers and other key stakeholders. Develops and manages strong, trust-based partnerships with external stakeholders, particularly CROs, and by embedding excellence, agility, and innovation into the clinical delivery model Ensures the technical maintenance, monitoring and continuous improvement of an effective operational and partnership model within GCO Fosters a sustainable and future-proof vendor management approach aligned with Chiesi’s portfolio and long-term strategic vision Develops and manages vendor partnership model and ensure appropriate governance to assure the highest quality delivery of clinical trials Collaborates in vendor selection, onboarding and integration of digital platforms and services, collaborating with the involved internal parties (GICT, etc..) Defines Third-Party Vendors Governance, vendors panels and oversees setup activities, timelines and performance to ensure alignment with company SOPs, study protocols, and company objectives Partners closely with Procurement to support preparation of Master Service Agreements/Service Level Agreements and related documentation and to ensure compliance with contractual agreements Develops and mantains collaborative relationships with external partners to enhance delivery capabilities and innovation Collaborates in the assessment and technical implementation of current and new processes/procedures within GCO, in light of the revision of GCO operational model Partners with study teams to prepare for and engage in interaction with strategic providers to ensure successful outcomes for studies (e.g. revision of RFP, change order requests) Partners with study teams to prepare for and engage in interaction with strategic providers to ensure studies success (e.g.participation to BDM, KOM and other applicable study level interactions) Fosters a culture of continuous improvement, setting high performance standards, focusing on exceeding objectives 8–10 years of relevant experience in Clinical Operations, with solid knowledge of clinical trial management and the different phases of clinical development ~ Proven experience in clinical trial budget negotiation and management ~ Experience managing external partnerships, such as CROs, vendors or other third-party providers involved in clinical studies ~ Experience in vendor governance and performance management, including oversight of service quality, delivery performance and issue resolution ~ Fluency in English, both written and spoken, with the ability to operate effectively in an international environment ~ Strong collaboration skills, with the ability to build and maintain positive working relationships with internal stakeholders and external partners ~ Ability to influence and engage cross-functional stakeholders, aligning different parties toward shared business objectives ~ Strong problem-solving and continuous improvement mindset, with the ability to identify operational challenges and drive sustainable solutions across complex stakeholder environments ~ Strong negotiation and mediation skills with the ability to identify balanced solutions that support both operational needs and company priorities ~ Experience working in cross-functional and international environments, c