Sr Clinical Operations Specialist (home-based sponsor dedicated) Updated: Yesterday
Location: Australia-Asia Pacific - AUS-Home-Based
Job ID: 24005932
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 not only make Syneos Health easier to work with, but to make us easier 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 to change lives.
Job Responsibilities
• Responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions.
• Assists Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines.
• Creates and assists with maintenance of project files, handles project correspondence.
• Participates in file audits.
• Prepares and maintains site manuals, reference tools and other documents.
• Maintains, updates, and inputs clinical tracking information into databases.
• Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client.
• Manages shared mailbox, processes site requests and routes correspondence appropriately.
• Coordinates the ordering, packaging, shipping and tracking of site supplies and materials.
• Assists with coordination of team meetings, attends meetings and prepares accurate meeting minutes and action items.
• Routinely anticipates, identifies and resolves potential issues and implements corrective actions, seeking guidance as needed to resolve more complex issues.
• Maintains overall awareness in the field of clinical research, as well as assigned areas, by completing all necessary and assigned training.
• May provide training or mentorship to more junior level Clinical Operations Specialists (COS).
Qualifications
What we're looking for
• Associates degree preferred or equivalent.
• Experience in clinical research/pharma/biotech or related field considered in lieu of degree.
• Good knowledge of medical terminology, clinical data, and ICH/GCP preferred.
• Ability to successfully prioritize and work on multiple tasks.
• Strong attention to detail, accuracy and organizational skills.
• Excellent communication, presentation, and interpersonal skills.
• Ability to embrace new technologies.
• Minimal travel up to 10% may be required.
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 take into consideration transferable skills from previous roles.
Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status.
#J-18808-Ljbffr