Role Description 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 compliance, tracking milestone progress in real time. - If forecasted timelines are not reached, provides clear rationale for delays, assists with 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 (WIs) in a timely manner, keeps training records updated, and ensures timesheet compliance. - Ensures 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 project direction from the designated country start-up advisor (CSA) and SAM. May serve as a point of contact for the SAM/PM 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 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. - Local Site ID and Feasibility Support: Provides support with site selection lead and PM/SAM to ensure appropriate sites are selected for individual studies based on the requirements of the clinical trial. - May be asked to perform: 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 - Equivalent experience, skills, and/or education will also be considered. Requirements - Tasks, duties, and responsibilities as listed in this job description are not exhaustive. - The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. - The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Benefits - 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. - Committed to building an inclusive culture – where you can authentically be yourself. - Continuously building the company we all want to work for and our customers want to work with.