Sponsor dedicated SSU

Overview Sponsor dedicated SSU & Regulatory Specialist II. Madrid. Updated: YesterdayLocation: ESP-Remote (Madrid)Job ID: Sponsor dedicated SSU & Regulatory Specialist II. 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 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. 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 the quality deliverables at the country level; follows project requirements and applicable country rules with moderate oversight from the SSU Country Manager. Works within forecasted submission/approval timelines and ensures they are complied with and tracks milestone progress in real time in the SSU tracking system. If forecasted timelines are not reached, investigates and provides rationale for delays, supports contingency planning, and escalates the issue as soon as identified. Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion. Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WI), keeps training records updated, and ensures timesheet compliance. Supports continuous improvement of quality in all Site Start-Up (SSU) components at the country level where assigned (submissions, essential document collection, communication to Competent Authorities and ECs, etc.). Ensures all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements. Responsible for the Local Submissions Specialist - follows project direction from the designated country start-up advisor (CSA) and SAM. May serve as a point of contact for the PM/SAM during start-up on allocated projects. Complies and/or reviews essential document packages for site activation and may be involved in essential document collection from site. Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authority submissions as required. Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA and other local regulatory authorities as needed within the country; includes safety notifications as required by local rules, with moderate oversight from the SSU Country Manager. May act as liaison and facilitator between investigational sites and functional leads for related tasks and/or issues. Oversees site activation end to end process at country/site level. Country Start-Up Advisor - acts as Subject Matter Advisor for in-country performance within Site Start-Up. Supports country-level intelligence on start-up (SU) and clinical trial regulatory (CTR). Ensures that local country regulatory intelligence pertaining to the activities of the local SU and CTR team is maintained in the central repository, including submissions, notifications to data protection authorities, and other local regulatory actions. Provides input to local SOPs and WI and supports creation of internal training materials on local legislation requirements. Provides input to assist with EC or CA issue resolution at the country level. Local Site ID and Feasibility Support – provides support with site selection lead and PM/SAM to ensure appropriate sites are selected for studies based on trial requirements. May be asked to perform Local Investigator Contract and Budget Negotiator – supports SAM to agree on country template contracts and budgets; produces site-specific contracts; supports submissions for proposed contracts and budgets; negotiates with sites and ensures contract execution; performs quality control and arranges execution of CTAs and archival of documents. Qualifications Bachelor’s Degree Detailed understanding of clinical trial process across Phases II-IV and ICH GCP Ability to understand clinical protocols and study specifications Detailed understanding of clinical trial start-up processes Ability to manage external vendors to contract effectively Strong organizational skills with ability to handle multiple tasks effectively Strong written and verbal communication and interpersonal skills Ability to manage multiple project budgets with increased complexity and value Quality-driven in all managed activities Good negotiating skills Good problem-solving skills Demonstrated ability to work independently as well as part of a team Get to know Syneos Health 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. Summary Roles within the Site Start-Up/Site ID job family are responsible for managing and executing the site identification process in accordance with regulations, SOPs, and project requirements. This includes completing and negotiating site confidentiality agreements (CDAs) and site information forms (SIFs) with sites, maintaining, reviewing, and reporting on site performance metrics, serving as the primary point of contact for investigative sites, and tracking the completion of site identification for sites. Impact and Contribution: Individual contributors with responsibility in a professional or technical discipline who may manage two or fewer employees. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies. 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. We also encourage you to join our Talent Network to stay connected to additional career opportunities. Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Syneos Health® (Nasdaq: SYNH) is a leading 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. We support a diverse, equitable and inclusive culture. Phone: Fax: Toll-Free: 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 and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at: Email: #J-18808-Ljbffr