• Lead the management (from draft initiation to execution) of contractual documents including, such as work orders, agreements and amendments, consultancy agreements, confidentiality agreements, Request for Proposal (RFP) tools
• Ensure that all SOPs are adhered to and applicable laws and regulations and GCP guidelines are followed with respect to vendor selection, activity outsourcing processes and contractual documents managed by SCP.
• Drive the outsourcing process for clinical studies for assigned compounds or other clinical development activities.
• Initiate requests for information (RFI) and/or requests for proposals (RFP) customized to the outsourced services
• Guide new vendors through clinical and IT qualification processes
• Lead clinical study team and Development Solutions stakeholder interactions with vendors during the outsourcing process and in case of scope updates are needed.
• Lead negotiations of vendor contracts and amendments to ensure a cost-effective, expeditious and successful solution to outsourcing needs.
• Support the clinical study teams and Development Solutions stakeholders to identify and find solutions to issues with vendors which impede the successful outcome of the provision of services.
• Prospectively identify issues from a budget, timeline and quality perspective and prioritize rectification.
• Ensure that vendor performance is regularly assessed and shared with SCP members and relevant interfaces during regular debriefings (GCSO or other Development Solutions functions, Legal, Clinical Development Quality, Vendors, etc.).
• Participate in the development and management of a vendor management program ensuring a collaborative, transparent relationship.
• Serve as assigned vendor manager and first point of escalation for strategic partners and preferred suppliers.
• Support financial assessments of vendors.
• Support the development of business cases
• Contribute to the development of a global library of standard contract templates in collaboration with Legal.
Experience with other professional services companies is an advantage. Experience managing and/or working with CROs is a plus.
• Bachelor’s degree is required in any of several concentrations: science, finance, legal, business. Master’s degree in the same concentrations is preferred. A scientific and business background is a plus.
• A track record of successful vendor negotiations is a plus.
• Team leadership and strong people management skills
• Ability to work effectively in a global environment
• Excellent interpersonal skills
• Ability to deliver mentoring and training to peers and other groups
• Excellent verbal and written communication in English
• Good negotiation, facilitation, and conflict management skills
• Proficiency in the Microsoft office suite
• Excellent time management and organizational skills
• Ability to forecast budget projections
• General knowledge of clinical development including, but not limited to:
o FDA/EMA and other relevant regulations and guidance
o ICH/GCP and regulatory environment
o Development processes and roles/responsibilities
• Ability to identify, assess and implement best practices throughout the function.
• Proactive and flexible approach, drive and follow through
• Independently manage multiple concurrent responsibilities in a global environment of changing priorities, without close supervision
Michael Bailey International is acting as an Employment Business in relation to this vacancy.