Job Description

Updated: Yesterday
Location: Montreal, QC, Canada
Job ID: 146974

Description

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

In this role, your primary focus will be to conduct External GCP audits. You will work with some of the industry\'s sharpest minds and enjoy flexibility to conduct your professional pharmaceutical and biotech clinical audits as the lead and primary auditor. To be successful in this role, you will need to have extensive experience as the lead or primary auditor conducting external clinical trial audits, deep understanding of CRO auditing and excellent communication skills. You will:

• Schedule, conduct and document assigned audits of projects in accordance with approved procedures, schedules and formats. Specific audit areas will include, but are not limited to investigator sites, trial master and project management files, data management activities and files, safety reporting, final study reports, and vendors.
• Lead for-cause audits to address suspected critical audit findings, fraud, or misconduct related to investigator sites, vendors, etc. These complex and highly sensitive audits may involve issues related regulatory violations, controlled substances, and other highly sensitive matters.
• Write and issue audit reports in accordance with standard company formats and timelines, ensuring clear communication of audit findings to the relevant project team members.
• Maintain accurate and timely documentation of QA auditing activities.

Essential Requirements:

• Bachelor\'s degree in the science/health care field or equivalent combined education and experience
• Extensive experience in 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 (GCP) regulations and guidelines

Desired Requirements:

• Knowledge of medical terminology
• Ability to handle multiple tasks to meet deadlines in a dynamic environment
• Strong organizational, presentation, documentation and interpersonal skills with diverse cultures
• The ability to travel up to 75%

At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn\'t align perfectly, we encourage you to apply anyway. At times, we will consider transferable skills from previous roles. We also encourage you to join our to stay connected to additional career opportunities.

Why Syneos Health? Here, you\'re a part of the big picture. You will collaborate with colleagues across clinical and commercial disciplines to guide premarket development through post-market commercial strategy. Every project is a chance to solve a new challenge, learn from your colleagues, and advance your career. The diversification and breadth of our new and existing partnerships create a multitude of career paths and employment opportunities. Join our game-changing, global company dedicated to creating better, smarter, faster ways to get biopharmaceutical therapies to patients. Experience the thrill of knowing that your everyday efforts are contributing to improving patients\' lives around the world.

Work Here Matters Everywhere | How are you inspired to change lives?

Syneos Health companies are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled)

Syneos Health has a voluntary COVID-19 vaccination policy. We strongly encourage all employees to be fully vaccinated. Additionally, certain local governments or Syneos Health customers may have vaccine requirements that apply to some of our employees. These employees are required to submit proof of vaccination to Syneos Health and maintain compliance with these requirements.

At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position will include a competitive compensation package, Health benefits to include Medical, Dental and Vision, Company match 401k, flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos Health complies with all applicable federal, state, and municipal paid sick time requirements.

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