Sponsor dedicated SSU Specialist with experience in contract negotiation and budgets. Madrid.

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.

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 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 (WI) 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.).

Ensure 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. 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.

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 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, e.g., Competent Authority submissions, EC submissions, notifications to data protection authorities, etc.

May be asked to perform Local Investigator Contract and Budget Negotiator – provides support to SAM to agree on country template contract and budget. Produces site‑specific contracts from country template and provides support in submissions for proposed contract and budget for site. 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.

EEO Statement We are committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate.

Madrid, Community of Madrid, Spain

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