Site Activation Specialist II

🔥 0 minutes ago

🇨🇦 Canada – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👻 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

• Responsible for quality deliverables at the country level and compliance with project requirements and applicable country rules • Track submission and approval milestones in the SSU tracking system and investigate or escalate delays • Monitor basic project financial aspects and contracted hours/tasks, escalating discrepancies • Review and comply with SOPs and Work Instructions and maintain training records and timesheet compliance • Support continuous improvement across Site Start-Up components, including submissions, essential document collection, and communications with authorities and ethics committees • Submit relevant documents to the Trial Master File • Prepare and submit central and local ethics committee applications, regulatory authority applications, and hospital approval submissions • Prepare ongoing submissions, amendments, periodic notifications, and safety notifications as required by local rules • Liaise between investigational sites and functional leads and oversee the end-to-end site activation process • Act as a country-level subject matter advisor on site start-up and clinical trial regulatory requirements • Maintain local regulatory intelligence in the central repository and support data protection guidance • Provide input to local SOPs, work instructions, and internal training materials • Support ethics committee or competent authority issue resolution • Support site selection and feasibility activities • Support investigator contract and budget negotiation, contract production, quality control, execution, archival, and metadata capture

🎯 Requirements

• Bachelor’s Degree • Detailed understanding of clinical trial process across Phases II-IV and ICH GCP • Ability to understand clinical protocols and associated study specifications • Detailed understanding of clinical trial start-up processes • Ability to manage external vendors to contract effectively • Strong organizational skills with ability to handle multiple tasks effectively • Strong written and verbal communication and interpersonal skills • Ability to manage multiple project budgets with increased complexity and value • Quality-driven in all managed activities • Good negotiating skills • Good problem-solving skills • Demonstrated ability to work independently as well as part of a team • Equivalent experience, skills, and/or education may also be considered

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Reasonable accommodations when appropriate