Overview
Single Sponsor CTM (Medical Affairs) EMEA locations
Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team applies a drug development mindset to understand customer needs and shape solutions. Whether you join a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers to deliver for our customers and for those in need.
Discover what your 25,000 future colleagues already know:
* We are passionate about developing our people through career development, training, and rewards; supportive management; and peer recognition.
* We are committed to building an inclusive culture aligned to our purpose – Driven to Deliver – to shape solutions with meaningful patient impact.
* We aim to build a company and customer base that partners across the world to shape the future of healthcare and accelerate patient progress.
Responsibilities
* Non-Interventional studies: collaborate with the Principal Investigator, review budgets and milestones, and coordinate with multiple stakeholders.
* Locations: Croatia, France, Ireland, Poland, Spain, United Kingdom.
* Perform site qualification, initiation, interim monitoring, site management activities, and close-out visits (on-site or remote) ensuring regulatory, ICH-GCP and/or GPP adherence; assess site performance and staff; communicate/escalate issues; develop action plans as needed; maintain knowledge of applicable guidelines and company SOPs.
* Verify informed consent processes; protect participant confidentiality; assess safety and data integrity factors at investigator sites.
* Clinical Monitoring/Site Management Plan activities: assess site processes; perform Source Document Review; verify CRF data accuracy; apply query resolution remotely or on-site; support data capture and compliance with EDC requirements.
* Investigational product (IP) handling: inventory, reconciliation, storage/security checks; ensure proper dispensing and labeling; address blinded or randomized information considerations; ensure IP is handled per protocol and regulatory requirements.
* ISF/ TMF oversight: review ISF for accuracy and completeness; ensure archiving of essential documents per local guidelines; communicate archiving expectations to sites.
* Documentation and site support: maintain necessary project documents; support recruitment and retention efforts; input data into tracking systems for status and action items.
* Project scope, budgets, and timelines: manage site-level activities and communications to meet objectives; adapt to changing priorities under Lead CRA guidance.
* Act as primary liaison with site personnel or in collaboration with other CRAs/CMA; ensure training and compliance across sites and teams.
* Prepare for and attend Investigator Meetings and sponsor meetings; participate in global clinical monitoring/project staff meetings; attend project-specific training.
* Support audit readiness and follow-up actions at site and project levels.
* Real World Late Phase: Site Management Associate I title; responsibilities include site lifecycle support, knowledge of local requirements for real-world designs, data abstraction, and collaboration with sponsor affiliates and local staff.
Qualifications
* Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
* Knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements.
* Strong computer skills and adaptability to new technologies.
* Excellent communication, presentation, and interpersonal skills.
* Ability to travel up to 75% on a regular basis.
* US ONLY: Information for facility access related to employment; comply with site requests as a condition of employment; failure to provide information may affect site entry and ongoing employment.
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 your role, you’ll be encouraged to take initiative and challenge the status quo in a dynamic environment. Learn more about Syneos Health at the link below:
http://www.syneoshealth.com
Additional Information
Tasks, duties, and responsibilities are not exhaustive. The Company may assign other tasks at its discretion. Equivalent experience or education will be considered. The Company reserves the right to determine what constitutes equivalency. This document does not create an employment contract. Some language reflects legislative requirements in various countries, including the EU Equality Directive. The Company is committed to compliance with the Americans with Disabilities Act, including reasonable accommodations where appropriate.
Summary
Roles within the Clinical Trial Management job family oversee the development, coordination, and implementation of Late Phase (Medical Affairs) non-interventional studies. You will collaborate with the principal investigator, act as a liaison among research subjects, client teams, investigators, and clinic operations, and plan logistics and resources. You will track progress against milestones, client deliverables, and budget while ensuring global and regional regulatory compliance. This role may involve directing some work or managing small teams depending on scope.
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