Please note: As per company policy you need to use your own laptop for work.

Can be remote, prefers onsite 2 times week Raleigh
12 Months

Primary Purpose / Regulatory Responsibilities: The Clinical Outsourcing Manager (COM) partners with program and functional stakeholders within Patient Evidence, Patient Solutions, Patient Impact and beyond to provide financial, vendor and outsourcing expertise for clinical studies and development activities.

• There are two key areas of focus for the COM – which require specific & different experience and expertise:

1. Outsourcing of clinical study conduct,
2. Outsourcing of other clinical development services, e.g. data studies sponsored by, Services Agreements, License Agreements, Consultancy Agreements.

• The COM will support the clinical study teams and other clinical development activity stakeholders within Patient Evidence, Patient Solutions, Patient Impact and beyond throughout the clinical drug development process of an asset and clinical innovation activities.
• The COM drives the outsourcing and vendor selection process and leads the subsequent study/project award and contract negotiation process.
• As the representative for Strategic Clinical Partnering (SCP), the COM ensures that project related outsourcing timelines are met by managing strategic partners and external vendors selected for the project.
• The COM ensures that outsourced activities utilize preferred, quality vendors, and leads contract negotiations to provide the highest quality services at the lowest possible price.
• The COM may also be SCP s vendor manager for strategic partners or preferred suppliers, under the direction of the Vendor Management Lead.

Accountabilities

• Lead the management (from draft initiation to execution) of contractual documents including, but not limited to:
• Work orders, agreements and amendments. o Consultancy agreements. o 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 other clinical development activity stakeholder interactions with vendors during the outsourcing process and in case of Product 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 other clinical development activity 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 (e.g. with stakeholders within Patient Evidence, Patient Solutions, Patient Impact, Legal, 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. Identify business improvement opportunities and participate and/or lead in creating solutions which improve SCP efficiency and effectiveness. Interact on daily basis with SCP members and other relevant interfaces to ensure integration of activities. Support outsourcing initiatives according to the organization s requirements.
• Additionally, the COM responsible for clinical study activities will: Oversee a minimum of 10 studies for which the whole study is outsourced. Support maintenance of partnership bid grids for all study phases and across partnerships including yearly and ad hoc updates and negotiation of new services. Support the clinical study team with the generation of cost estimates for incorporation into the clinical study/program budgets, and with subsequent budget planning and forecasting for specific assigned studies. Attend and contribute to financial review meetings organized by Finance.
• Collaborate with the study teams and finance to achieve annual financial Clients. Represent the SCP function at clinical study team and clinical sub-team team meetings when needed. In addition, meet informally with relevant clinical study team members on a weekly basis at study start-up and periodically during the conduct of clinical studies to assure that vendors are providing services as negotiated.
• Interact on daily basis with internal stakeholders such as Vendor Management Lead, Vendor Leads (VLs) and Strategic Partnering Leads and other relevant interfaces to ensure integration of activities. Travel requiring overnight stays, possibly global, is required.

Education – Bachelors

Competencies

• 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:
• FDA/EMA and other relevant regulations and guidance
• ICH/GCP and regulatory environment
• 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.
• Ability to analyze, evaluate and resolve complex issues and team dynamics. Ability to build efficiencies and improve processes and procedures. Exercises independent judgment.
• Ability to achieve consensus in a group through complex and thorough deliberations. Support clinical programs with efficient and effective resolutions. Ability to work under tight timelines without sacrificing quality. At least 2 years of relevant experience in the Pharmaceutical, Biotechnology, or Clinical Research Organisation (CRO) industry.
• 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.
• Good leadership skills, networking skills, and communication skills. Demonstrates clear and articulate verbal, written and presentation skills with good command of the English language and the appropriate comportment to represent at meetings. In all regions, fluency in multiple languages is a plus. The SCOM for clinical study activities must additionally have direct or indirect knowledge and experience of clinical trial conduct.