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Director, Clinical Contract Operations

Reference Number: 2787
Location: MD

Our client is a leading pharmaceutical company.  They have asked us to assist them in their search for a Director, Clinical Contract Operations.

This leadership role will be responsible for building and managing a high-performing and best-in-class clinical contracting group for our client.  This role will require effective collaboration and partnership with CROs, clinical, legal and procurement functions within the company.

Major tasks and responsibilities will include:

  • Manages all aspects of study-level vendor selection, contracting and contract life-cycle management.  End to end process includes request for proposal and quotes, vendor assessment, decision summary and award notification, contracting and managing contract lifecycle.
  • Works with Clinical Operations to define accurate program and trial budget forecast with relevant benchmarking and cost analysis tools and techniques.
  • Drafts, negotiates and executes project-specific agreements and amendments on time and with desired quality.
  • Serves as a subject-matter expert of the company’s contracting system.  Manages lifecycle of a contract through the system from first upload of an agreement to final approval, subsequent change orders and documentation management.
  • Ensures that all decisions and documentation of the contracting process is compliant and audit-ready.
  • Trains project teams on contracting and vendor selection process.  Supports clinical ops project teams on process/system challenges with ongoing contract management.
  • Partners with clinical functions & procurement to influence new vendor selection based on historical vendor performance.
  • Serves as a point person for CROs for supporting and answering all questions related to site contracting policies and guidelines.

We seek candidates with the following qualifications:

  • Bachelor’s degree in the life sciences.  Operations Management background preferred.
  • 10+ years of experience working with/at CROs on clinical trial contracting.
  • Proven experience building and managing high-performing teams.
  • Extensive knowledge and understanding of investigator site contracting and outsourcing processes.
  • Comprehensive knowledge of clinical and pharmaceutical drug development process.
  • Ability to set and manage priorities, budget, resources and performance targets.
  • Exceptional at operations management.  Ability to deliver with high quality at a fast pace.
  • Continuous process improvement and simplification mindset.  360 degree change management skills.
  • Excellent written and verbal communication skills.
  • Good problem-solving and conflict resolution skills.
  • Flexibility and ability to thrive in a rapid paced environment, manage effectively and capable of making difficult decisions in uncertain/evolving situations.
  • Approachable and collaborative.
  • Develops people.  Builds high-performing teams.
  • Strategic thinker with ability to translate strategy to operational execution.
  • Influential communicator.
  • Results-Oriented.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2787. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.