On-site monitor * open to diverse EMEA countries *

Syneos Health, Inc.; Lembang; On-site; IDR 1,106,417,000 - 1,508,751,000; Full time

Job summary

Syneos Health, Inc. is seeking an on-site monitor fluent in German to support global studies across diverse EMEA countries. The role involves site management, regulatory compliance, and collaboration with sponsor teams to drive study delivery.

The candidate should have at least 1 year of onsite monitoring experience, a science/healthcare degree, and strong skills in CTMS/EDC, MS Office, and communication. Travel up to 60% is expected.

Qualifications

• Required - German language (written and spoken).
• Minimum 1 year of onsite monitoring experience.
• BA/BS in science/health care field or nursing degree or equivalent.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint), email/voicemail, and CTMS/EDC systems.
• Previous site management experience (in-house/on-site/Study Coordinator).
• Excellent communication, time management, organizational, documentation and customer service skills.
• Knowledge of Real World Late Phase study designs and regulations including GPP.

Responsibilities

• Perform site management activities in compliance with SOPs and WIs.
• Ensure compliance with local regulations and ICH-GCP guidance.
• Conduct site management per SoW and SMP; identify sites and qualification.
• Manage site start-up, regulatory tasks and remote/on-site monitoring.
• Review ISF for accuracy; reconcile with TMF and archiving requirements.
• Maintain communication with site staff and project team; escalate issues as needed.
• Support audit readiness and participate in Investigator Meetings.

Skills

German language

Communication skills

Time management

Organizational skills

Teamwork

Travel flexibility

Education

BA/BS in science/healthcare or nursing

Tools

Microsoft Office

CTMS/EDC systems

Job description

Description

On-site monitor ** open to diverse EMEA countries **

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.

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. o Site identification – may contact sites to obtain interest in study participation, confirm contact details, retrieve documents for consideration, etc. o Site Qualification
• Ensures selection of appropriate sites for assigned studies. o Site Start-Up – With minimal supervision, ability to perform activities for assigned sites working with study start-up and regulatory. o 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.

Qualifications

• Required - German Language - written and spoken**
• Minimum 1 year relevant onsite monitoring experience required.
• 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.

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.