Site Activation Specialist Ii

Performs assigned activities within the country that lead to start-up of investigative sites in all phases of clinical trials. Responsible for delivery, with moderate oversight from the Line Manager and specialist knowledge in one or more of the following functional areas: investigator site contracts, ethics and regulatory submissions, collection and review of essential documents required for site initiation and site activation activities. Ensures local activities are undertaken in accordance with agreed timelines, allocated budgets, and required quality standards. Ensures an efficient start-up process on assigned studies. May act as main contact with Regulatory Authorities (RA) and Central/Regional Ethics Committees (ECs). Under the direction and some level of supervision of the Project Lead (PL) or SAM (Site Activation Manager) as appropriate, may directly interact with Customers when receive requirements from RA or other local regulatory party. Accountable to the PL/SAM at the project level and line manager for deliverables. At a project level, may act as SAM for local studies. May provide support as the Country Start-Up Advisor (CSA).

JOB SUMMARY

Performs assigned activities within the country that lead to start-up of investigative sites in all phases of clinical trials. Responsible for delivery, with moderate oversight from the Line Manager and specialist knowledge in one or more of the following functional areas: investigator site contracts, ethics and regulatory submissions, collection and review of essential documents required for site initiation and site activation activities. Ensures local activities are undertaken in accordance with agreed timelines, allocated budgets, and required quality standards. Ensures an efficient start-up process on assigned studies. May act as main contact with Regulatory Authorities (RA) and Central/Regional Ethics Committees (ECs). Under the direction and some level of supervision of the Project Lead (PL) or SAM (Site Activation Manager) as appropriate, may directly interact with Customers when receive requirements from RA or other local regulatory party. Accountable to the PL/SAM at the project level and line manager for deliverables. At a project level, may act as SAM for local studies. May provide support as the Country Start-Up Advisor (CSA).

**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 SAM. May serve as a point of contact for the PM/SAM (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.
- May act as liaison and facilitator between investigational sites and functional leads for related tasks and/or issues. Oversee 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 that the 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 - Provides support to S