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.
Here, there’s no shortage of challenging work, learning and opportunities. Because we offer many services to varied clients, our knowledgeable professionals gain experience across a large section of the industry. Our client roster consists of more than 550 organizations including all 20 of the largest global biopharmaceutical companies.
This opportunity is with Syneos Health Consulting. Your primary focus will be to conduct External GCP Audits. You will work with some of the industries sharpest minds, and will 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 sponsor audits, deep understanding of CRO auditing and excellent communication skills.
You will be joining an industry-leading consulting firm, Syneos Health, specializing in the biopharmaceutical industry providing services across a comprehensive range of key Practice Areas including commercial strategy and planning, medical affairs, 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 successful commercial strategies for our clients.
In this role, 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. More specifically:
- 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.
- Conduct audit debriefs with project teams and/or sponsor
- Writes 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.
- Serve as a trainer and mentor to newly hired QA Auditors.
- Serve as Global Lead Auditor on projects as assigned.
- Maintain subject matter expertise through training (internal and external), review and/or preparation and presentation of papers, review of guidelines, and regulations, etc.
- Participate in Trusted Process meetings such as Kick-off, Quick Start Camp, and Quality Finish Camp.
Please note - This is a remote-based position (any US location) that will require up to 75% travel.
Along with demonstrated initiative, uncompromised integrity and a results-oriented mindset, the ideal candidate has:
A Bachelor’s Degree in the science/health care field or equivalent combined education and experience
Extensive experience in clinical quality assurance auditing (GCP)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.
Knowledge of medical terminology preferred.
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.
The ability to travel up to 75%