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Vice President Operations

Reference Number: 3464
Location: MA

Our client is a leading clinical research organization.  They have asked us to assist them in their search for a Vice President of Operations. 

Major tasks and responsibilities will include:

  • Builds and manages collaborative working relationships with the client, cross- functional program team members, investigators and key study site personnel.
  • Leads and manages all clinical development operations to ensure highest quality and consistency of methods and interpretation.
  • Contributes to and coordinates clinical team strategy updates.
  • Through managers, ensures that all clinical trial activities, including study start-up, close-out and report writing are planned and accomplished consistent with protocols, SOPs and regulatory practices in support of corporate objectives.
  • Oversees the process to prepare all clinical documents and presentation, as needed.
  • Oversees electronic and paper filing systems to ensure access and compliance.
  • Monitors adherence to protocols and determine study completion.
  • Provides scientific and clinical input to study-related documents and analysis plans including informed consent forms, clinical research forms, statistical analysis plans and clinical study reports.
  • Develops and implements a robust portfolio management program to ensure all cross functional activities are properly aligned with delivery objectives.
  • Collaborates with existing team and key stakeholders to devise best practices and continuous improvement of project management.
  • Creates a strategy and framework for harmonization and resource modeling in support of the global client and corporate initiatives identified.
  • Actively participates in evaluating and streamlining proposal development activities and strategy in conjunction with new business development.
  • Provides client facing to validate satisfaction with services provided and leverage to promote additional work or new opportunities.
  • Plays critical role in proposal bid defense requirements as necessary.
  • Constantly challenges and evaluates processes and new technology supporting enhancements as required to maximize efficiency and reduce cost.
  • Ensures that operational spending is controlled and expense budgets are met in conjunction with the annual plan established.
  • Champions clinical operations strategic planning with the team.
  • In conjunction with line managers, establishes individual goals for all members of the team in support of corporate objectives.
  • Provides timely and consistent feedback to direct reports with regard to individual and team goals and the achievement.
  • Actively promotes radical and/or creative thinking among line managers to develop strategies and identify opportunities for new business and revenue growth.

We seek candidates with the following qualifications:

  • Requires a Bachelor’s degree in a science related field; advance degree preferred.
  • Must have a minimum of 15 years of experience in research operations; with 2 years of experience at an executive managerial level.
  • Prior CRO, medical device, and/or biotechnology experience are a must.
  • Must have a working knowledge of cross-functional development functions, including clinical operations, regulatory affairs, safety and medical affairs.
  • Must have a proven knowledge of GCP, FDA, and ICH regulations and guidelines.
  • Must have strong planning, decision-making and process improvement skills.
  • Requires strong leadership and project management skills.

If interested, please email your resume as a Word attachment to us, reference 3464.  No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.