Clinical Outsourcing Lead

Job Description

JOB DESCRIPTION: 

• Ensure the protection of clinical outsourcing business interests.  

• Accountable to minimize business risk, and maximize research dollars in each contract.

• Provide expert contracts and outsourcing guidance to internal and external stakeholders:

• Act as a central point of contact for business related issues and facilitate conflict resolution.

• Leads and manages cost estimate processes for high level scenario planning.

• Leads study, program, and asset level outsourcing cost analysis efforts.

• Situational outsourcing consultation and guidance.

• Directly negotiates business terms, clinical operations fees, and scope of services with Alliance Partners (AP's), CRO's and other service providers.

• Provides leadership and oversight in one or more key areas within outsourcing (i.e. PSC Development, FCPA Process, etc.).

• Embrace and drive forward the current outsourcing model with AP’s & selected service providers.

• To meet business needs, assess and apply innovative outsourcing solutions harmonized with unique and specialized partner facing model.

• Understands and utilizes novel project planning and costing tools/software to evaluate options, negotiate costs and recommend optimal value-added solutions for APs / Preferred Suppliers.

• Liaises frequently with customers and stakeholders to ensure they have realistic expectations of the contracting process, external providers and the contracting environment.

• Provides expertise to study teams by identifying and evaluating available outsourcing and resourcing options to facilitate optimal decision-making at a global and local level.

• Manages the outsourcing process as an agent of Business Operations:  

• In collaboration with study teams, gains an in-depth understanding of study requirements in order to secure appropriate level and type of resources and services from Contract Research Organizations (CROs) and other service providers -identifies and brokers appropriate study execution options -requests proposals from AP's & other service providers -analyzes and negotiates complex proposals and provides recommendations and analysis to study teams for decision making -selects vendors in collaboration with study teams -negotiates contracts related to services totaling in the millions of dollars within the agreed legal and budgetary process framework 

• Responsible for the preparation of Request for Proposals.  

• Responsible for the preparation, negotiation and finalization/execution of full-service Alliance Partner Work Orders, 3rd party Vendor Services Agreements, Investigator Initiated Research Agreements, Outcomes Research Agreements, Publications Agreements, Change Orders, Consultant Agreements, Master Services Agreements, Clinical Research Agreements and other types of ad-hoc agreements.

• Directly negotiates proposed changes to standard contract language within guidelines provided by the Legal Division; raises significant requested changes to standard contract language to the Legal Division and significant budget exceptions to the appropriate stakeholders for resolution.

• Designs creative and risk-averse payment schedules in order to drive vendor performance, protect financial interests and comply with Sarbane-Oxley, Generally Accepted Accounting Principles and other regulations.

• Oversees Per Subject Cost estimation and Clinical Study Agreements execution.

• Communicates impact of significant contractual changes and associated budgets to BUs/RUs and other stakeholders proactively to ensure funding availability. Works with BUs/RUs to analyze service provider forecasted budgets to ensure appropriate and acceptable costs for services are presented by providers.

• Provides oversight and leadership as a subject matter expert in one or more key areas of outsourcing expertise, and participates in special projects as needed in support of the OWN IT culture.

• Identifies process gaps. Works with Business Operations Outsourcing Group Lead to drive the creation and implementation of contracting and outsourcing tools to best fill such gaps and support the business.

• Responsible for obtaining ‘real time’ external knowledge, expertise, feasibility data (supplier surveillance) and assessment of external commercial market place.

• Participates on critical, highly visible, global initiatives, within and outside of Dev Ops, contributing value-added sourcing, contracting and budgetary related expertise

Qualifications

• BA or BS degree and/or recognized amount of work experience (preferably in a related discipline). 

• An advanced degree (MBA, JD, etc.), prior management responsibilities, and/or substantial work experience is preferential for the Director Level (P05).

• Clinical trials Sponsor experience, CRO operational and/or BD experience, or other trial related experience, including significant experience negotiating and drafting clinical trial-related agreements is required.  

• Excellent oral/written communication skills and proficiency with MS Office applications (Word/PPT/Excel) required: experience with ACW, Clear Trials, Grants Manager and / or other industry cost and planning tools preferred.

TECHNICAL SKILLS

Finance / clinical budgeting 

• Demonstrates clear understanding of activity based costs along study path; additionally, Director Level (P05) demonstrates expertise in strategic cost relationships and links (program, asset, portfolio, etc.) for planning and forecasting, negotiation, and higher level presentation 

• Understands components of clinical & per subject costing & use of industry bench-marking

Operational expertise in study scheduling and placement                             

• Knowledge of clinical study outsourcing; Director Level (P05) requires expert knowledge in clinical trial development outsourcing 

• Understanding of operational impact to timelines, budget, and quality desired, and required for Director Level (P05)

Negotiating and contracting skills:      

• Knowledge and experience of contracting with external service providers 

• Application of contracting strategies at enterprise levels 

• Internal and external influencing abilities for expectation and timeline management; for Director Level (P05), proven experience required 

• Identifies and leads efforts to examine multiple solutions or innovative options in solving highly complex problems directly impacting a Global Business Unit/Global Operating Unit or Sub Business Unit/Sub Operating Unit

Additional Information

Thanks

Warm Regards

Ricky Bansal

732-429-1925