Principal Site Contracts

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Site Operations
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20007294 Requisition #

JOB SUMMARY

 

Manages administration and negotiation processes for site contracts that support projects within Clinical Operations. Ensures site contract documentation is in compliance with sponsor and Company requirements.   Identifies project and/or individual site contract related problems and works with internal and external team members to provide and implement solutions. Establishes strong working relationships with customers and internal project teams.  Leads internal team education or process improvement initiatives.  Participates in business development presentations as a subject matter expert in processing site contracts within the Company. May identify and/or lead internal team education or process improvement initiatives.

 

JOB RESPONSIBILITIES

 

·        Establishes, maintains and updates training material for site contract team.

 

·        Actively participates in higher level discussions about overall company goals, departmental objectives, and specific project aims.

 

·        Subject matter expert equipped to help resolve global site contracting issues.  Escalation point within the organization for site contract negotiators to seek assistance.

 

·        Tracks and measures project and team progress through collection of cycle time metrics and other quality key performance indicators (KPIs).  Communicates metrics, KPIs, and other relevant project information to team and departmental leadership.  Proposes solutions to issues that may arise during a project or contract life cycle.

 

·        Works closely with Legal to harmonize site contract templates and site contract language negotiation parameters to reflect sponsor's master service agreement terms and required processes. 

 

·        Works closely with sponsor and Project team to generate investigator budgets and negotiation parameters

 

·        Identifies possible contract or process operational risk and proactively works to provide solutions.  Establishes strong working relationships with customer and internal project teams.  Escalates deviations to senior management and/or Legal Department.

 

·        Serves as a resource to business development and represents site contracts at internal or customer meetings.

 

·        Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.

 

·        Generates amended documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; initiates and introduces creative ideas and solutions.

 

·        Creates and maintains document status reports and updates department team members on a regular basis; ensures appropriate documentation is maintained for all exceptions.

 

·        Collaborates with internal and external legal, finance, and clinical operations departments, including communicating and explaining legal and budgetary issues.

 

·        Represents the Company at professional meetings or seminars. 




QUALIFICATION & REQUIREMENTS 

 

·        BS degree in Pharmacy, other health-related area, or equivalent combination of education and experience.  Advanced degree preferred

 

·        Extensive experience in a CRO and related contract management or site start-up experience 

 

·        Thorough knowledge of applicable regulations, drug development, and clinical project management procedures 

 

·        Strong presentation, documentation, and interpersonal skills 

 

·        Proficient in MS Office (Word, Excel, and PowerPoint), MS Project, email, and Internet 

 

·        Ability to handle multiple tasks to meet deadlines, delivering high quality work in a dynamic environment

 

·        Good line management abilities

 

·        Strong leadership skills; ability to teach/mentor team members

 

·         Ability to coach employees to reach performance objectives

 

·        Ability to recognize and take appropriate action when employee performance is not acceptable


 

Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.  Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.