Site Activation Specialist II

Join to apply for the Site Activation Specialist II role at Syneos Health. Site Activation Specialist II 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. 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 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 the forecasted submission/approval timelines and ensures they are complied with and tracks milestone progress in the agreed‐upon SSU tracking system in real time; if forecasted timelines are not reached, investigates and provides clear rationale for delays, provides support on contingency plan to mitigate impact, 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 (WIs) in a timely manner, keeps training records updated accordingly 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 the project direction provided by the designated country start‑up advisor (CSA) and SAM. May serve as a point of contact for the PM/SAM (or designee) during start‑up on allocated projects. Complies and/or reviews essential document packages for site activation and may also be involved in essential document collection from site. Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required. May act as liaison and facilitator between investigational sites and functional leads for related tasks and/or issues. Oversee site activation end to end process at country/site level. Country Start‑Up Advisor – acts as Subject Matter Advisor for in‑country performance within the Site Start‑Up. Supports country‑level intelligence on start‑up (SU) and clinical trial regulatory (CTR). Ensures that local country regulatory intelligence is maintained on the central repository, provides support for data protection at the country, and offers guidance on local requirements. May be asked to perform: Local Investigator Contract and Budget Negotiator – supports SAM to agree on country template contract and budget, produces site‑specific contracts from country template, and negotiates budgets and contracts with site via Site Contracts Service Centre and SAM with Sponsor until resolution of issues and contract execution. Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata. Qualifications Bachelor’s Degree. Detailed understanding of clinical trial process across Phases II‑IV and ICH GCP. Ability to understand clinical protocols and associated 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. 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. 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 or specialty, but may manage two or fewer employees. May direct the work of lower‑level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Established and productive individual contributor. May manage defined components of projects or processes within area of responsibility. Requires practical knowledge of a professional area, typically obtained through education combined with experience. Seniority level Entry level Employment type Full‑time Job function Information Technology #J-18808-Ljbffr