Site Activation Specialist I

🕒 September 21

🇵🇱 Poland – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👻 Ghost score 20%

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Logo of Syneos Health

Syneos Health

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

• Follow project direction from the designated country start-up advisor and SAM • Serve as a point of contact for the SAM/PM or designee during start-up on allocated projects • Compile and/or review essential document packages for site activation • Collect essential documents from sites • Prepare and submit Central EC, Local EC, RA, and other local regulatory or hospital approval applications under supervision • Prepare ongoing submissions, amendments, periodic notifications, and safety notifications required by local rules • Liaise between investigational sites and functional leads for related tasks and issues • Oversee the end-to-end site activation process at country/site level • Support site selection and feasibility activities with the site selection lead and PM/SAM • Support country template contract and budget negotiations • Assist in producing site-specific contracts • Assist with budget and contract negotiations with sites, the Site Contracts Service Centre, SAM lead, and Sponsor • Assist with quality control and execution of clinical trial agreements • Archive documents into repositories and capture metadata

🎯 Requirements

• Associate’s Degree or equivalent combination of education and training • Good understanding of clinical trial process across Phases II-IV and ICH GCP • Ability to interact effectively and appropriately with investigative site personnel • Good organizational skills and attention to detail, with proven ability to handle multiple tasks effectively • Ability to take direction from multiple individuals and set priorities accordingly • Ability to effectively communicate across multiple function groups (clinical team, PM, Director) • Demonstrated ability to work independently and as part of a team • Ability to utilize problem-solving techniques effectively • Quality-driven in all managed activities • Flexibility and willingness to adapt to a rapidly changing environment and learn/perform new functions • Strong computer skills, including Word, Excel, PowerPoint, Publisher

🏖️ 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

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