Clinical Trial Operations Specialist

Clinical Trial Operations Specialist - Sr Project Specialist (Sponsor Dedicated) in Barcelona or Madrid. 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 continuously look for ways to simplify and streamline our work to make Syneos Health easier to work with and 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. WORK HERE MATTERS EVERYWHERE 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. 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 Set‑up, maintain and/or close out project files and study information (e.g., regulatory documents, Trial Master File, enrollment, Adverse Events, Serious Adverse Events, site supplies, Institutional Review Board re‑approvals, data queries) on a variety of databases and systems. Attend, participate, prepare and distribute meeting minutes and action items for both internal and external meetings (sponsor, trusted process, functional, investigator meetings). Follow up with team members on action items to closure. Maintain timely and effective communication among team members and site staff. Keep Project Leadership and Clinical Research Associates fully apprised of sites and study status. May contact site staff as needed for critical information. Provide administrative support to Project Leads and functional leads. Ensure all study documents are archived based on the appropriate guidelines and policy. Provide support for quality assurance activities, including preparation for audits and internal review, prepare documentation and follow through to resolution on actionable issues. Qualifications Associate’s Degree (or equivalent) in life sciences, medicine, pharmacy, nursing or related field, or equivalent combination of education and experience. Knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements. Strong organizational skills. Ability to manage time and work independently. High proficiency with full MS Office applications. Strong communication, presentation and interpersonal skills (written and spoken), with an ability to inform, influence, convince and persuade. Ability to travel if necessary (approximately 5%). High level of competence in English. Get to Know Syneos Health Over the past five 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. 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. The Company is committed to compliance 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. Summary Roles within the Clinical Project Management job family are responsible for planning, directing, creating and communicating clinical study timelines. They gather input from cross‑functional teams and create plans that help the team produce deliverables on schedule. They ensure consistency of clinical study and processes across clinical trials, overseeing and resolving operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures, good clinical practice and specific country regulations such as site and vendor selection, preparing clinical trial budgets, ensuring studies are conducted within protocols, monitoring progress and following up with team members and line managers when issues develop. They implement and prepare the clinical development strategy as outlined by the clinical teams and may develop trial recruitment strategies. These roles provide organizational support and serve under supervision; they typically do not require advanced education or training beyond broad knowledge of operational systems. Seniority level Mid‑Senior level Employment type Full‑time Job function Research, Analyst, and Information Technology Referrals increase your chances of interviewing at Syneos Health by 2x. Sign in to set job alerts for “Clinical Trial Specialist” roles. #J-18808-Ljbffr