Senior Clinical Trial Specialist
hace 6 días
Syneos Health is a leading global biopharmaceutical company that accelerates customer success. We offer innovative solutions to simplify and streamline our work, making it easier for us to work with and for our employees.
Our clinical development model puts the customer and patient at the center of everything we do. Whether you join us in a partnership or full-service environment, you'll collaborate with passionate problem solvers who innovate as a team to help our customers achieve their goals.
We're agile and driven to accelerate the delivery of therapies because we're passionate about changing lives. Our 29,000 employees across 110 countries know that work here matters everywhere.
Why Syneos Health?
- We develop our people through career development and progression, supported by engaged line management, technical training, peer recognition, and a total rewards program.
- We're committed to our Total Self culture, where you can be authentically yourself. This culture unites us globally, and we take care of our people.
- We continuously build the company we want to work for and our customers want to work with. When we bring together diverse thoughts, backgrounds, cultures, and perspectives, we create a place where everyone feels like they belong.
About this role:
This Senior Clinical Trial Specialist will lead activities within Mexico to start-up investigative sites in all phases of clinical trials. The successful candidate will be responsible for delivering quality on country-level deliverables, following project requirements and applicable country rules, with oversight from the SSU Country Manager.
The role involves working within forecasted submission/approval timelines, tracking milestone progress in real-time, and escalating discrepancies in a timely fashion. You will also review and comply with Standard Operating Procedures (SOPs) and Work Instructions (WIs) and ensure timesheet compliance.
You will be responsible for one or more of the following functions:
- Local Submissions Specialist: Compiling and reviewing essential document packages for site activation, preparing and submitting Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required.
- Local Investigator Contract and Budget Negotiator: Supporting the Site Start-up Lead to agree on country template contract and budget.
Key responsibilities include:
- Providing quality on country-level deliverables and following project requirements and applicable country rules.
- Working within forecasted submission/approval timelines and tracking milestone progress in real-time.
- Reviewing and complying with SOPs and WIs and ensuring timesheet compliance.
- Preparing and submitting documents for site activation and regulatory submissions.
- Supporting the Site Start-up Lead to agree on country template contract and budget.
Salary: $60,000 - $80,000 per year, depending on experience.
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