Global Senior Project Specialist (Sponsor Dedicated) Germany

Global Senior Project Specialist (Sponsor Dedicated) Germany

Syneos Health® is a leading fully‑integrated life sciences services organization that accelerates customer success.

We are seeking a Clinical Trial Operations Specialist to join our team in Germany as part of a single‑sponsor partnership.

• Job Responsibilities
• Set‑up, maintain and/or close out project files and study information (e. g., regulatory documents, Trial Master File, enrollment, adverse events, site supplies, Institutional Review Board re‑approvals, data queries) on a variety of databases and systems.
• Attend, participate, prepare and distribute meeting minutes and action items for both internal and external meetings (sponsor, trusted process, functional, investigator).

Follow up with team members on action items to closure.

• Maintain timely and effective communication among team members and site staff.

Keep Project Leadership and Clinical Research Associates fully apprised of sites and study status.

Contact site staff as needed for critical information.

• Provide administrative support to Project Leads and functional leads.
• Ensure all study documents are archived in accordance with guidelines and policy.
• Support quality assurance activities, including preparation for audits and internal review; prepare documentation and follow through to resolution of actionable issues.

Qualifications

• Associate’s Degree (or equivalent) in life sciences, medicine, pharmacy, nursing or related field, or equivalent combination of education and experience.
• Knowledge of Good Clinical Practice / ICH guidelines and other applicable regulatory requirements.
• Strong organizational skills and ability to manage time and work independently.
• High proficiency with Microsoft Office applications.
• Strong written and oral communication, presentation and interpersonal skills; ability to inform, influence, convince and persuade.
• Ability to travel, if necessary, approximately 5 % of the time.
• High level of competence in English.
• Summary
• Planning, coordination and conduct of complex, regulatorily defined tasks.
• Seamless trial operation and communication to all applicable stakeholders.
• Timely delivery of all materials, documentation and information needed to set up, execute and deliver assigned trials.
• Independent management of complex technical systems to ensure accurate reporting to senior management.
• Oversight of trial supplies, documentation, submissions and other operational parameters.

The Senior Project Specialist maintains and coordinates the logistical aspects of clinical projects and provides overall support to functional leads to ensure successful completion of project deliverables.

The role operates independently, with minimal day‑to‑day oversight, and may coordinate activities of other Project Specialists.

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.

The Company may assign other tasks, duties or responsibilities at its discretion and with no prior notice.

Equivalent experience, skills or education will also be considered; qualifications of incumbents may differ from those listed.

The Company is committed to complying with equal‑employment opportunity and ADA requirements, providing reasonable accommodations where appropriate.

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