Sr SSU & Regulatory Specialist

Job Description

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 (CSA) and PM/SSUL. May serve as the primary point of contact for the PM/SSUL (or designee) 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.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 (SU) and clinical trial regulatory (CTR).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. In absence of legal advisor or subject matter advisor for data protection at the country, provides clear data protection guidance at a country level on data protection statements that need to be included on those documents which the Sponsor has contracted to the Company start-up group to adapt to local requirements. This will typically include the Principal Investigator/Informed Consent and the Confidential Disclosure Agreement/contract template. Provides input in local SOPs and WI. Support for the creation of internal training materials on for 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/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 - Produces site-specific contracts from country clinical trial agreement (CTA) 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 SSUL 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.Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.Bachelor s Degree5+ years of experience in Ethics Committees (EC) / Regulatory Authorities (RA) submission processExcellent understanding of clinical trial process across Phases II-IV and ICH GCPGood understanding clinical protocols and associated study specificationsExcellent understanding of clinical trial start-up processesProject management experience in a fast-paced environmentGood vendor management skillsStrong organizational skills with proven ability to handle multiple projectsExcellent communication, presentation and interpersonal skillsQuality-driven in all managed activitiesStrong negotiating skillsStrong problem-solving skillsAbility to mentor, lead and motivate more junior staffDemonstrate an ability to provide quality feedback and guidance to peersContribute to a training and Quality assurance plan within SSU and update SOPs/WI,

Keyskills :
presentation activations otivate