Ssu & Regulatory Specialist Ii - Montreal - Hybrid

2 weeks ago

Montréal, Canada Syneos Health Full time

Description

Site Start-Up & Regulatory Specialist II

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE

Why Syneos Health

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.
We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Job responsibilities
- Responsible for the quality deliverables at the country level; follows project requirements and applicable country rules, with moderate 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: investigates and provides clear rationale for delays, provides support on 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 (WI) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.
- Supports continuous improvement of quality in all Site Start-Up (SSU) components at the country level where assigned (submissions, essential document collection, communication to Competent Authorities and ECs, etc.).
- Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.

Responsible for one or more of the following functions at the country level:

- 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 PM/SSUL (or designee) during start-up on allocated projects. Complies 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.
- 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 moderate oversight 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 - Provides support to SSUL to agree on country template contract and budget. Produces site-specific contracts from country template. Provide support in submissions for proposed contract and budget for site. Provides support in negotiating budget and contract with site via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues and contract execution. Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.

**Qualifications**:
What we're looking for
- 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

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