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Description
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to make Syneos Health easier to work with and to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies because we are passionate about changing lives.
Discover what our 29,000 employees across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
* We are passionate about developing our people through career development, progression, supportive management, training, peer recognition, and rewards.
* We are committed to our Total Self culture, where you can be yourself. We prioritize taking care of our people.
* We value diversity of thoughts, backgrounds, and perspectives to create an inclusive environment where everyone belongs.
Job Responsibilities
Performs site qualification, initiation, monitoring, management activities, and close-out visits (on-site or remotely), ensuring compliance with regulatory standards, ICH-GCP, GPP, and protocols. Uses judgment to evaluate site performance, provides recommendations, and escalates serious issues. Maintains knowledge of relevant guidelines and regulations.
* Verifies informed consent process and protects patient confidentiality.
* Assesses site processes, reviews source documents, verifies data accuracy, and applies query resolution techniques.
* Supports investigational product inventory and verifies proper dispensing.
* Reviews Investigator Site Files and ensures compliance with archiving standards.
* Documents activities and supports subject recruitment and retention strategies.
* Manages project scope, budgets, timelines, and communicates with site personnel.
* Prepares for meetings, participates in audits, and maintains compliance with training requirements.
* For Real World Late Phase, supports study lifecycle, data collection, and collaboration with stakeholders.
Qualifications
Requirements include a bachelor’s degree or RN, knowledge of GCP/ICH, good computer skills, excellent communication, and ability to travel up to 75%.
Get to know Syneos Health
We have worked with 94% of FDA-approved drugs, 95% of EMA products, and over 200 studies. Join us to challenge the status quo and make an impact.
Additional Information
Tasks and responsibilities may be assigned as needed. Qualifications may be considered equivalent. We comply with all relevant legislation and are committed to an inclusive, accessible environment.
Senior level
* Mid-Senior level
Employment type
* Full-time
Job function
* Research and Science
Industries
* Biotechnology Research, Pharmaceutical Manufacturing, Research Services
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