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Outsourcing Manager, Clinical Operations

Inovio is revolutionizing the fight against cancer and infectious diseases. Our immunotherapies uniquely activate best-in-class immune responses to prevent and treat disease, and have shown clinically significant efficacy with a favorable safety profile. With an expanding portfolio of cancer immunotherapies and clinical studies, the company is advancing a growing product pipeline. Partners and collaborators include Roche, the University of Pennsylvania, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, US Dept. of Homeland Security, and University of Manitoba. For more information, visit www.inovio.com. 

Job summary

The Outsourcing Manager will support the outsourcing and contracting needs of Inovio’s clinical programs. This Outsourcing Manager will be a member of the clinical project team and will be key team member during the generation, negotiation and execution of clinical trial vendor contracts. The individual will work closely with our legal department ensure that the contract terms, statement of work (SOW) and budget meet the needs of both the clinical trial and all legal requirements. This individual will also be responsible for managing and facilitating any change orders to the SOW.

Essential job functions and duties

Lead vendor evaluation and selection process including generation of Request for Information (RFI) if new vendors need to be identified.
Ensure confidentiality agreements are executed as required.
Generate the Request for Proposal (RFP), performing analysis of the responses, and leading the clinical study team discussion of vendor selection.
Work closely with legal and clinical operations and other relevant functional groups for review and escalation of contract and budget issues.
Assist the legal team in contract negotiation and execution for vendors supporting a clinical trial.
Act as the primary contact with vendors for negotiation of the scope of work, study assumptions and budgets.
Support cross-functional relationships with clinical operations, legal and finance
Maintain study-level financial tracking of vendor contracts with ongoing reconciliation of study budgets versus vendor invoices.
Participate in study team and report status of study-specific contracts.
Responsible for the generating requests for Master Service Agreements (MSA), work orders, purchase orders and Consulting Agreements as requested
Perform follow-up activities for accounts payable issues as requested by clinical teams or other functional groups.
Follow up or escalate vendor requests for payment information.
Perform other duties as required.

Minimum requirements

4 year degree in scientific or business discipline, MBA preferred

3-5 years of procurement /category management expertise in a clinical research setting

 Knowledge of GCP and regulatory requirements regarding clinical trial management

Essential requirements

Strong verbal and written communication skills as well as interpersonal and organizational skills
Excellent negotiation skills
Ability to work in a team environment and collaborate with internal functional groups.
Analytical and strategic thinking skills
Attention to detail, ability to prioritize and handle multiple projects.
Self-starter, able to communicate well within a team environment. 
Proactive in managing and completing tasks in a timely fashion.
Proficiency in MS Office applications, especially Excel

Travel:

Minimal travel required

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