Senior Project Specialist – Clinical Trial Assistant, Bilingual English/French Preferred

🔥 22 hours ago

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• support global clinical trials within a sponsor-dedicated environment. • play a critical role in study execution, Trial Master File management, and cross-functional project coordination while working with a high-performing clinical team. • provide essential operational and project support across multiple clinical studies. • Maintain, organize, and reconcile Trial Master Files (TMF) within Veeva Vault. • Collect, review, track, and file essential and regulatory study documents. • Ensure TMF completeness, inspection readiness, and compliance with study requirements. • Support study startup document collection and tracking activities. • Track study timelines, milestones, enrollment activities, and protocol-related deliverables. • Assist with regulatory submissions and related documentation activities. • Help coordinate study supplies and operational logistics as needed. • Schedule meetings, prepare agendas, capture meeting minutes, and track action items to completion. • Support internal and external project meetings with study teams, sponsors, and investigative sites. • Maintain project trackers, status reports, KPIs, and study metrics. • Ensure study documentation is maintained according to company SOPs, GCP, and regulatory requirements. • support inspection and audit readiness activities. • Assist with quality review processes and follow-up of corrective actions. • Archive study documentation according to established policies and guidelines. • Operate independently with minimal day-to-day supervision. • Act as a key project resource and escalation point for assigned responsibilities. • Mentor and support junior Project Specialists when appropriate. • Serve as a project representative during internal and external audits.

🎯 Requirements

• 2–3+ years of Clinical Trial Assistant (CTA) experience in a clinical research setting. • Direct CTA experience must be clearly demonstrated on your resume. • Strong experience managing large volumes of clinical trial documentation. • Hands-on experience with Veeva Vault TMF required. • Excellent organizational skills and exceptional attention to detail. • Experience supporting study startup activities and document collection processes. • Strong communication and stakeholder management skills. • Ability to work independently in a remote environment. • English proficiency required. • French proficiency preferred. Candidates should be comfortable reviewing French-language documents. Reading and written comprehension are highly valued, while fluent spoken French is not required but a huge plus !

🏖️ Benefits

• 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.