[Hiring] Site Activation Specialist I @Syneos Health

Role Description

Responsible for one or more of the following functions:

• Local Submissions Specialist:
  • Follows the project direction provided by the designated country start-up advisor (CSA) and SAM.
  • May serve as a point of contact for the SAM/PM (or designee) during start-up on allocated projects.
  • Compiles and/or reviews essential document packages for site activation.
  • May also be involved in essential document collection from site.
  • Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required and under supervision.
  • Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA, and other local regulatory authorities as needed within the country.
  • Includes safety notifications as required by local rules, with oversight from the SSU Country Manager.
  • May act as liaison and facilitator between investigational sites and functional leads for related tasks and/or issues.
  • Oversee site activation end to end process at country/site level.
• Local Site ID and Feasibility Support:
  • Provides support with site selection lead and PM/SAM to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial.
• Local Investigator Contract and Budget Negotiator:
  • Supports the SAM to agree on country template contract and budget.
  • Assists in producing site-specific contracts from country template.
  • Under supervision, assists in negotiations of budget and contract with site and via Site Contracts Service Centre and SAM lead with Sponsor until resolution of issues and contract execution.
  • Assists with quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.

Qualifications

• 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 good 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, as well as part of a team.
• Utilize problem-solving techniques effectively.
• Quality-driven in all managed activities.
• Flexibility and willingness to adapt to rapidly changing environment and learn/perform new functions.
• Strong computer skills, including Word, Excel, PowerPoint, Publisher.

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.
• Commitment to building an inclusive culture – where you can authentically be yourself.
• Driven to Deliver – capturing the passion of our colleagues to shape solutions that impact lives.
• Continuous improvement of the company for employees and customers.

Company Description

Over the past 5 years, we have worked with:

• 94% of all Novel FDA Approved Drugs.
• 95% of EMA Authorized Products.
• Over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.