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Regulatory Specialist with Clinical Trials Experience
hace 2 meses
**About Us**
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
**Our Culture**
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.
**Job Responsibilities**
- General - Responsible for providing quality on deliverables at the country level and follows project requirements and applicable country rules, with oversight from the SSU Country Manager.
- Works within the forecasted submission/approval timelines and ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time; if forecasted timelines are not reached provides clear rationale for delays, assists with contingency plan to mitigate impact, and escalates the issue as soon as identified.
- Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
- Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.
- Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.
**Key Responsibilities**
- Local Submissions Specialist - Follows the project direction provided by the designated country start-up advisor (CSA) and SSUL. May serve as a point of contact for the SSUL/PM (or designee) during start-up on allocated projects. Compiles and/or reviews essential document packages for site activation and 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 overight from the SSU Country Manager.
- Local Site ID and Feasibility Support - Provides support with site selection lead and PM/SSUL 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 SSUL to agree on country template contract and budget. Assists in producing site-specific contracts from country template. Under supervision assist in negotiations of budget and contract with site and via Site Contracts Service Centre and SSUL 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.
**What We're Looking For**
- 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 functions.
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