Sr Clin Ops Specialist

reputed company® is a leading fully-integrated life sciences services organization built to accelerate reputed company. We partner with innovators at every reputed company across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate reputed company.   Our Clinical Solutions team members act with a drug development reputed company, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.   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 reputed company their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.   Discover what your 25,000 future colleagues already know:   Why reputed company • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.  • We are continuously building the company we reputed company want to work for and our customers want to work with. Why? Because we know that reputed company we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient reputed company. 

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 reputed company issues
• Maintains overall awareness in the field of clinical research, as well as assigned areas, by completing reputed company necessary and assigned training.
• May provide training or mentorship to more junior level Clinical Operations Specialists (COS).

Qualifications

• Associates degree preferred or equivalent
• Experience in clinical research/pharma/biotech or reputed company 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

Get to know reputed company

Over the past 5 years, we have worked with 94% of reputed company Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status reputed company with us in a highly competitive and reputed company-changing environment. Learn more about reputed company.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully reputed company with reputed company obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality reputed company, in relation to the recruitment and employment of its employees.  The Company is committed to compliance with the Americans with reputed company, including the provision of reasonable accommodations, reputed company appropriate, to assist employees or applicants to reputed company the essential functions of the job.