Site Management Associate II / Sr SMA (Home - Based, US)

1001 Syneos Health, LLC; North Carolina; Hybrid; USD 70,000 - 145,000; Full time

Benefits offered by this job

Company car

Health benefits

401k

Stock Purchase Plan

Paid time off

Job summary

Syneos Health is seeking a Site Management Associate II / Sr SMA for a home-based role in the United States. The SMA II will manage sites across the full study lifecycle, ensuring compliance with SOPs, regulatory requirements, and SMPs, while supporting site staff and physicians to accelerate trial progress.

The role requires a BA/BS in a science/healthcare field or nursing degree, strong communication, organizational and data-management skills, and willingness to travel up to 60% as needed.

Qualifications

• BA/BS in science/health care field or nursing degree or equivalent.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).
• Previous site management or Study Coordinator experience.

Responsibilities

• Manage sites for assigned studies and provide site support throughout the study lifecycle.
• Ensure SOPs, WIs, SMPs, and local regulations are followed; liaise with investigators.
• Support site identification, qualification, start-up, and close-out activities.
• Coordinate remote and on-site monitoring and maintain ISF/TMF alignment.
• Train site staff, assist with recruitment strategies, and manage data queries.

Skills

Communication

Time management

Organizational skills

Customer service

Team collaboration

Education

BA/BS in science/healthcare or Nursing degree

Tools

Microsoft Office

Job description

Site Management Associate II / Sr SMA (Home - Based, US)

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. 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 deliver - for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

• 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 building an inclusive culture - where you can authentically be yourself.
• Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.

Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

The Site Management Associate II (SMA II) is responsible for site management activities for assigned sites. For site-based studies, the SMA II is the primary contact for the site and is responsible for providing site support throughout the full study lifecycle from site identification through closeout. The SMA II provides support, training and customer service to physicians and site staff to speed performance and alleviate site burden for real world research studies. 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 - With minimal supervision, 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. Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and SMP, within required timelines. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. Demonstrates diligence in protecting the confidentiality of each subject/patient. 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. Prepare for, attend and participate in 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. 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.

Qualification Requirements

BA/BS degree in science/health care field or nursing degree or equivalent combined education and experience. Must be proficient in Microsoft Office Suite (Word, Excel, and PowerPoint), email/voicemail, and Clinical Trial Management and EDC systems. Previous site management (in‑house, on‑site, Study Coordinator) or equivalent experience. Excellent communication, time management, organizational, documentation and customer service skills. Knowledge of local requirements for Real World Late Phase study designs as well as Real World Research and relevant regulations including GPP. Excellent customer focus (internal and external) and able to interact professionally with a client organization and study site. Willingness to work within a team‑oriented environment. Ability to work in a “virtual” team setting as well as work independently, seeking guidance as appropriate. Ability to handle multiple tasks (across multiple studies as necessary) and prioritize accordingly to achieve study timelines. Sound problem solving and analytical skills. Excellent command of written and spoken local language, if not English, as well as English required. Ability to develop good working relationships via oral communication and good phone etiquette. Ability to travel up to 60% on a regular basis depending on assignments and study phase.

AtSyneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality‑of‑life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

Salary Range: $70,100.00 - $145,000.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.

Get to know Syneos Health Over the past 5 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.

Learn more about Syneos Health. http://www.syneoshealth.com

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.

Discover what our Syneos Health colleagues already know: work here matters everywhere. Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients. We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We’re a growing, global company dedicated to advancing our talent past their initial role. Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much‑needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career in which you’re guaranteed to: Partner with the most diverse team of experts in the industry. From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it. Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration. With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population. We are partners with purpose. We integrate seamlessly with our customers and do what’s best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life‑changing therapies worldwide.