Senior Clinical Operations Specialist (Equivalent to CTA role)* *Sinlge Sponsor Dedicated - Lead Pharma Company* *Bucharest - Office Based* Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success.
We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.
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. 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 and progression; supportive and engaged line management;
technical and therapeutic area training; peer recognition and total rewards program.
We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. *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).*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*Get to know Syneos Health*Over the past 5 years, we have worked with 94% of all 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 quo with us in a highly competitive and ever-changing environment.
Learn more about Syneos Health*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 comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.#LI-KU1