Site Management Associate

Syneos Health, Inc.; Northern (KY); Hybrid; USD 70,000 - 126,000; Full time

Benefits offered by this job

Health benefits

401k plan

PTO

Job summary

Syneos Health Site Management Associate is responsible for performing site management activities in accordance with SOPs and regulatory guidelines, including site qualification, start-up, monitoring, data reconciliation and documentation. The role requires travel up to 60%, strong communication, and proficiency with CRT systems.

You will collaborate with Sponsor teams, manage site communications, support recruitment activities, and ensure audit readiness while maintaining quality and timelines

Qualifications

• BA/BS in science/health care field or nursing degree, or equivalent combination of education and experience.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and email/voicemail.
• Experience in site management (in-house/on-site/study coordinator) or equivalent is required.
• Excellent communication, time management, organizational, documentation and customer service skills.
• Knowledge of Real World Late Phase study designs and related regulations (GPP) is a plus.
• Strong client-facing interaction abilities and team collaboration skills.
• Willingness to travel up to 60% regularly depending on assignments.

Responsibilities

• Perform site management activities in compliance with SOPs/WIs.
• Ensure compliance with local regulations and ICH-GCP where applicable.
• Conduct site management activities per SoW, SMP and guidelines.
• Identify and contact sites to generate interest and obtain required documents.
• Site qualification to ensure appropriate site selection.
• Site Start-Up activities with minimal supervision.
• Conduct remote and on-site monitoring across all study stages.
• Review ISF accuracy and reconcile with TMF; archive essential documents.
• Document activities via letters, trip reports, logs, and other project documents within timelines.
• Support subject/patient recruitment and retention strategies; data entry into tracking systems.
• Maintain effective communication with site staff and project team; escalate issues per SOPs.
• Maintain clinical tracking/management systems; ensure training/compliance with study protocol and data collection tools.
• Provide guidance for audit readiness and participate in Investigator Meetings; travel as required.

Skills

Microsoft Office Suite

Clinical Trial Management

EDC systems

Communication skills

Education

BA/BS in science/health care or nursing degree

Job description

Updated: Yesterday
Location: Remote, NC, United States
Job ID:25112557

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:

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 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.
• We are continuously building the company we all want to work for and our customers want to work with. 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

• 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.

At Syneos 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 - $126,100.00

Description

Site Management Associate

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:

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 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.
• We are continuously building the company we all want to work for and our customers want to work with. 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

• 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