Job Description & How to Apply Below
Location:
CAN-Remote
Job :
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 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.
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, ensures compliance, tracks milestone progress in the agreed SSU tracking system in real time; if timelines are not reached, investigates and provides clear rationale for delays, supports contingency plans, and escalates issues 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 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.).
Ensures all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.
Acts as Local Submissions Specialist – follows the project direction from the designated country start‑up advisor (CSA) and SAM; may serve as a point of contact for the PM/SAM during start‑up, reviews essential document packages for site activation, and may be involved in essential document collection from sites.
Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authority or hospital approval submissions; 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.
May act as liaison and facilitator between investigational sites and functional leads for related tasks and/or issues; oversees site activation end‑to‑end process at country/site level.
Serves as Country Start‑Up Advisor – acts as subject‑matter expert for in‑country performance within Site Start‑Up, supports country‑level intelligence on start‑up and clinical trial regulatory (CTR), maintains local country regulatory intelligence in the central repository, and provides input on local SOPs and WI.
Provides Local Site Feasibility Support – assists site selection lead and PM/SAM to ensure appropriate sites are selected for individual studies based on study requirements.
Functions as Local Investigator Contract and Budget Negotiator – supports SAM in agreeing on country template contract and budget, produces site‑specific contracts, negotiates budget and contract with sites via Site Contracts Service Centre and SAM with Sponsor until resolution of issues and contract execution; performs quality control and arranges execution of CTAs and archival of documents into repositories and metadata capture.
Qualifications
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 start‑up processes.
Ability to manage…
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