Senior Auditor-Biostatistics & Data Sciences CAPA Lead

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Updated: August 30, 2018
Location: Remote, United States
Job ID: 69859


You're driven, resourceful, and above all else - remarkably smart.

You love a good challenge. You are the first to roll up your sleeves and work with relentless energy until you solve the unsolvable, beat the unbeatable and you always come out on top. Passable doesn't cut it - you've got fire in your belly to learn more, do more and be more. For you, the sweetest success is shared success and you're known for your good nature. You'll fit right in at Syneos Health where we surround ourselves with the most talented and agile professionals in the industry, but we check our egos at the door.

Why Syneos Health? Join a game-changing global company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies - INC Research and inVentiv Health - we bring together more than 21,000 clinical and commercial minds to create better, smarter, faster ways to get biopharmaceutical therapies to patients. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment where you'll be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. Grow your career with a global company committed to shortening the distance from lab to life.


This opportunity is with Syneos Health Consulting, an industry-leading consulting firm specializing in the biopharmaceutical industry providing services across a comprehensive range of key Practice Areas including commercial strategy and planning, medical affairs, Quality and Compliance, Regulatory, risk and program management and pricing and market access. You'll join a team with industry focus, depth of functional expertise, and strong scientific and market knowledge that is uniquely positioned to tackle highly complex business and market challenges to develop achievable strategies for our clients.

In this role, you will work with clients as a CAPA specialist helping them to achieve a high level of compliance to meet Corporate Quality requirements. Specific responsibilities will include: serving as a CAPA lead as needed, helping CAPA leads complete plans, supporting evaluation of documentation of effectiveness check and providing information to CAPA leads that require updating in the Global Escalation Management system and assisting with implementation. Additional responsibilities include supporting with general process and system improvements within the Biostatistics and Data Sciences department.


Along with demonstrated initiative, uncompromised integrity and a results-oriented mindset, the ideal candidate has:
  • Six (6) years of pharmaceutical or health care related industry experience relevant to clinical research, including four (4) year of previous clinical investigator site auditing experience
  • BA/BS degree in the science/health care field or equivalent combined education and experience
  • Extensive experience in supporting/approving clinical CAPA plans and implementation.clinical quality assurance auditing and conduct of vendor audits (e.g. of central laboratories, clinical suppliers, IRBs, etc)
  • Strong knowledge of all applicable Good Clinical Practice regulations and guidelines.
  • Knowledge of medical terminology preferred. Well-developed communication skills and the ability to write and present concise, accurate reports and other necessary documentation.
  • Ability to handle multiple tasks to meet deadlines in a dynamic environment.
  • Strong organizational, presentation, documentation and interpersonal skills with diverse cultures.
  • Ability to negotiate and provide constructive feedback.
  • Must be able to work as part of a team as well as independently.
  • Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail

Full Syneos Health benefits which include
  • Competitive compensation and bonuses
  • Generous paid time off and company paid holidays
  • Comprehensive medical, dental, and vision package
  • Matching 401K • Dedicated training and support
  • Referral bonuses and other personalized quality of life conveniences

Make your work matter everywhere.Be a driving force in a rapidly evolving healthcare industry.

Syneos Health companies are affirmative action/equal opportunity employers (Minorities/Females/Vets/Disabled)
Years Exp 6-7
Position Type/Category Compliance/Regulatory
Corporate Direct
Travel More than 50%
Minimum Education Level Bachelor's Degree
Employment/Job Type Full Time
Employment Type Syneos Health position

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