Senior Site Activation Specialist
Job Responsibilities
* General – Responsible for quality deliverables at the country level; follows project requirements and applicable country rules, with minimal oversight from the SSU Country Manager. Forecasts submission/approval timelines, ensures compliance and tracks milestone progress in agreed upon SSU tracking system in real time; if forecasted timelines are not reached analyses data to provide clear rationale for delays, provides contingency plans to mitigate impact, and escalates the issue as soon as identified. Monitors financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion. Reviews and complies with SOPs and Work Instructions in a timely manner, keeps training records updated accordingly and ensures timesheet compliance. Ensures all relevant documents are submitted to the Trial Master File as per company SOP/Sponsor requirements. Ensures continuous improvement of quality in all Site Start-Up components at the country level where assigned (submissions, essential document collection, communication to Competent Authorities and ECs, etc.). May be involved in vendor management.
* Responsible for one or more of the following functions at the country level:
* Local Submissions Specialist – Follows the project direction and expertise provided by the designated country start-up advisor and PM/SAM. May serve as the primary point of contact for the PM/SAM 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.
* Oversees 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 minimal 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.
* Country Start-Up Advisor – Acts as Subject Matter Expert for in-country performance within the Site Start-Up. Acts as country-level intelligence on start-up and clinical trial regulatory.
* Ensures that local country regulatory intelligence, as it pertains to the activities of the local SU and CTR team, is maintained on the central repository, e.g., Competent Authority submissions, EC submissions, notifications to data protection authorities, notifications/applications to any other local/federal/national body, and import/export license applications where these are obtained with RA applications. Provides clear data protection guidance at the country level. Provides input in local SOPs and WI. Supports the creation of internal training materials on local legislation requirements. Responsible to identify solutions with EC or CA issue resolution at the country level.
* Local Site ID and Feasibility Support – Provides support 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 – Produces site‐specific contracts from country clinical trial agreement template. Reviews and owns site‐specific contracts from country template. Submits proposed CTA and investigator budget for site review. Negotiates budget and contract with site and via Site Contracts Service Centre and SAM with Sponsor until resolution of issues. Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.
* Line management / mentoring responsibilities – As part of developmental plans, it may be requested to provide support to management in activities such as interviewing and selection, professional development, performance management, and employee counseling and separations. Advises junior team members on administrative policies and procedures, technical problems, priorities and methods.
* May act as Country Delivery Lead: Responsible for operational delivery across the county portfolio for country participation through to site start up and ending in site activation and First Patient In. Analyses country and site metrics to ensure baseline project deliverables are being met to facilitate first patient in Sponsor projections; including planned baseline for completed regulatory green light with fully executed site contracts and increase efficiency in overall project delivery. Performs operational site level planning, including efficient allocation of resources within country.
* Ensure all relevant documents are submitted to the Trial Master File as per Company SOP/Sponsor requirements.
Performs assigned activities within the country that lead to start‐up of investigative sites in all phases of clinical trials. Responsible for providing delivery and expertise, with minimal oversight from the Line Manager in one or more of the following functional areas: investigator site contracts, ethics and regulatory submissions, collection, review and finalization of essential documents required for site initiation and site activation activities. Accountable 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 and Central/Regional Ethics Committees. Under the direction of the Project Lead or 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. May act as the Country Start‐Up Advisor or as a line manager / mentor for less experienced staff. At a project level, may act as SAM for local or regional studies.
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.
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