Associate Director, Clinical Operations

Job Locations US-MA-Bedford
Posted Date 6 months ago(3/19/2021 1:36 PM)
Job ID
2021-1426
# of Openings
1
Category
Clinical

Overview

Position Summary:

 

The Associate Director, Clinical Operations assists function leadership with day to day oversight of the teams executing clinical studies within a clinical program or multiple clinical programs.  This position works closely clinical study leads to ensure studies are inspection ready throughout their lifecycle. 

Responsibilities

Principal Responsibilities: 

 

  • Contributes to clinical development plans.
  • Suggests operational model to be applied to a given study.
  • Assists with the implementation of the vendor performance management and broad operational metrics monitoring program for assigned clinical programs.
  • Participates in the maintenance of the Clinical Quality Management System.
  • Assists functional leadership with conducting regular assessments of team resources and external service providers as appropriate.
  • Oversees day-to-day execution activities and implements any training needed to ensure activities are conducted in compliance with company SOPs, expectations and pertinent regulations.
  • Coaches function managers on the use of clinical project management methodology to develop and effectively manage timelines, budgets and resources.
  • Conducts inspection readiness checks of clinical studies within assigned programs.
  • Compiles performance updates for functional area leadership. 

 

Qualifications

Qualification Requirements:

  • Bachelor’s degree or higher in health profession, science and/or engineering field.
  • A minimum of 12 years experience in the pharmaceutical industry, including 10 years of relevant clinical research experience, 4 years supervisory experience, and 1 year in a leadership role.
  • Excellent written and oral communication skills.
  • Strong project management skills and analytical skills. 
  • Strong working knowledge of GCP, ICH guidelines, and regulatory rquirements for clinical trial management.
  • Excellent organizational skills, integrity, and attention to detail.
  • Ability to think proactively, strategically and creatively.
  • Strong interpersonal skills with ability to work in a team environment as well as independently.
  • Ability to assimilate new information rapidly, multi-task, and work across multiple projects.
  • Computer literacy, proficiency in MS Office, MS Project, etc.
  • Ability to travel approximately 35-40%.

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