Manager Global Clinical Control and Outsourcing

Location: RTP

The Manager, Global Clinical Control and Outsourcing and Procurement Operation will primarily support Clinical Development and Operational initiatives to contribute to the success of our clinical trials. This person will drive value, influence the ability for quality decision making, and mitigate supplier risks for the company. The successful candidate will be able to work cross-functionally, independently, and creatively.

Primary responsibilities for role:

• Strategic and integrative thinker for an important role that is responsible for Outsourcing across Clinical Development.
• Drive Requests for Information (RFI) and Requests for Proposals (RFP) process for all phases of clinical trials and all related services to drive value and ensure success of programs.
• Activities include, but not limited to: Writing, Coordination, Critical Analysis & Evaluation, Supplier Vetting and Due Diligence, Benchmarking, Contracting, Negotiation, etc.
• This role is a key partner to the clinical study teams, organizing the selection of service providers, coordinating requests for proposal and bid defenses, and negotiating work orders/change orders.
• Manages the identification and selection process of service providers for clinical studies in collaboration with the study management teams.
• Manage work assignment and provide guidance related to vendor proposals for job bids where complex algorithms for pricing work components, need to be fully understood prior to implementation, for potential issues and financial impact.
• Develops tools, templates and best practices. Estimate cost for new and pipeline clinical programs for Sr. Management.
• Manage/consult negotiators regarding contractual issues. Ensures all projects are reviewed on periodic basis and summarization of financial condition of project is communicated to R&D Finance.
• Act as primary business partner by provides guidance to study leaders and manager regarding potential change in scope of work requiring budget revision.
• Author and review Dept's Standard Operating Procedures (SOPs).
• Ability to manage and provide guidance to the Clinical Control Analyst and Global Clinical Control and Outsourcing Managers.

Requirements:

Knowledge, Skills, and Abilities

• Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.
• Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs and recommendations.
• Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
• Knowledgeable of ongoing and new development clinical programs.
• Excellent knowledge of the costs of clinical procedures, and how to process the data for estimating of clinical programs.
• Strong skills in computer systems and software to manage finance and invoice processing.
• Excellent skills in negotiation/influence, management, grant/contract administration, written, and oral communications.
• Excellent ability to manage multiple administrative activities.
• Excellent ability to establish good working relationships across functional areas in the company and to create and maintain alliances with outside providers.

Education:

• Masters or Bachelor's degree in business or related field.

Experience:

• Typically requires 12 years of experience in clinical research and development, of relevant experience in an outsourcing, vendor management and financial management support capacity or equivalent combination of education, training and experience, plus strong analytical, people and supervisory skills.
• Solid understanding of global clinical trials and drug development, including in Clinical Pharmacology, Phase I through Phase IV (post-marketing).
• Excellent leadership skills including ability to prioritize critical needs, act decisively, and handle a high volume of complex tasks within a given timeframe

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.

EEO/Minorities/Females/Disability/Veterans

Location: NORTH AMERICA : USA : NC-RTP:USNC0001 - RTP NC-Headquarters

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