Sr Site Management Associate

**Description**

**Senior Site Management Associate I, based in Spain or Portugal - Real World Evidence & Late phase**

Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason - we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.

**Why Syneos Health**
- #SyneosHealthLife means we’re committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
- We believe our success is a direct result of the people who are driving it - you We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
- 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**
- Perform site management activities in compliance with the Company and Sponsor (if applicable) Standard Operating Procedures (SOPs) and Work Instructions (WIs).
- Assure compliance with local regulations and appropriate guidance depending on assigned study design / classification. May include Good Pharmacoepidemiology Practices (GPP) and/or International Conference on Harmonization - Good Clinical Practice (ICH-GCP).
- Conduct site management activities as per agreed Scope of Work (SoW), Site Management Plan (SMP) and relevant guidelines.
- Site identification - may contact sites to obtain interest in study participation, confirm contact details, retrieve documents for consideration, etc.
- Site Qualification - Ensures selection of appropriate sites for assigned studies.
- Site Start-Up -Expert ability to perform activities for assigned sites working with study start-up and regulatory.
- Conduct of all remote and on-site monitoring activities through all study stages.
- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
- Assigned sites data review, assisting with data query resolution and missing data follow-up (only as applicable). Review data using data trend reports and knowledge of site practices. Ensure the resolution of data queries within agreed timelines. Utilize available hardware and software to support effective study data collection and review.
- Maintain effective, accurate and timely communication with site staff and project team, and ensure appropriate issue escalation and resolution as per SOPs with a focus on issue prevention.
- Maintains clinical tracking and management systems.
- Ensure all assigned sites are trained and compliant with requirements of the study protocol, informed consent process, data collection requirements/data collection tools and safety reporting.
- Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
- May attend Bid Defense Meetings, Investigator Meetings and/or sponsor face-to-face meetings.
- As required, collaborate and build relationships with Sponsor affiliates, medical science liaisons, and local country sponsor staff.
- Consult with Study Start-Up experts and RWCC to maintain current information of local and regional requirements for real world research study designs/classifications.
- Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations
- For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt, with the oversight of the Clinical Operations Lead or designee, to changing priorities to achieve goals / targets.
- Identify and communicate out of scope activities to Clinical Operations Lead.
- Attend, contribute to and present at study and department meetings.
- Identify operational efficiencies and process improvements to enhance Clinical Operations service delivery.
- May provide training or mentorship to more junior level SMAs. May perform training and sign off visits for junio