Site Activation Manager

🔥 15 hours ago

🇨🇭 Switzerland – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

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

• Collaborate with major functional areas across clinical trial and business functions • Identify and evaluate Site Start-Up issues, regulatory pathways, patient enrollment matters, and project risks • Ensure project deliverables meet internal and customer expectations • Develop and maintain customer relationships for assigned projects • Provide oversight of project start-up deliverables throughout project life-cycle maintenance • Manage regulatory maintenance activities, amendment submissions, authority and ethics committee communications, and import/export license extensions • Oversee executed amended clinical trial agreements and investigator budgets with investigator sites • Manage overall Site Start-Up timelines and realign plans as needed • Develop integrated timelines and report weekly progress, including mitigation plans for timing risks and gaps • Prepare and present Site Start-Up strategy and status at client meetings • Review project budgets against milestones and profitability expectations; take corrective measures as needed • Track out-of-scope work through backlog assignment • Prepare core submission documents and clinical trial application dossiers for amendments • Perform Regulatory Impact Assessments and oversee second-level reviews • Assist with updates to master Subject Information Sheets and Informed Consent Forms • Oversee collation, quality review, and submission of country-specific applications • Contribute to Site Start-Up department change initiatives • Submit relevant documents to the Trial Master File according to company SOPs and sponsor requirements • Perform other assigned work-related duties

🎯 Requirements

• Equivalent experience, skills, and/or education will also be considered • Ability to collaborate with Business Development, Alliance Management, Contracts and Proposals Development, SSU Country Managers, Project Management, Clinical, Data Management, and Medical Writing • Knowledge of Site Start-Up and project regulatory pathways • Ability to interpret complex issues and make sound business decisions • Ability to manage project deliverables, projections, reports, updates, risks, timelines, and budgets • Knowledge of life-cycle maintenance regulatory activities, including study maintenance and amendment submissions • Experience overseeing clinical trial agreements, investigator budgets, competent authority and ethics committee communications, and import/export license extensions • Ability to prepare core submission documents and clinical trial application dossiers for amendments • Ability to perform Regulatory Impact Assessments • Ability to develop or update Subject Information Sheets (SIS) and Informed Consent Forms (ICF) • Ability to oversee country-specific application collation, quality review, and submission • Ability to comply with Standard Operating Procedures, controlled document requirements, and Sponsor requirements • Ability to use professionally recognized tools for planning and management of scope, timeline, resources, and budgets

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Minimal travel may be required (up to 25%)