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Post : SSU & Regulatory Specialist II
• Assumes responsibility on quality deliverables at the country level; follows project requirements and applicable country rules. Forecasts submission/approval timelines and ensures they are complied; if forecasted timelines are not reached: provides clear rationale for delays, provides 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 Standard Operating Procedures (SOPs) and Work Instructions (WI) in a timely manner and keeps training records updated accordingly. Ensures 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.).
• Follows the project direction and expertise provided by the designated country start-up advisor (CSA) and SSUL. May serve as the primary point of contact for the PM/SSUL (or designee) during start-up on allocated projects. 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.
• Acts as Subject Matter Advisor for in-country performance within the Site Start-Up. Provides 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 dedicated staff, responsible for data protection at the country. Provides clear data protection compliance 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. Supports the creation of internal training materials on local legislation requirements. Provides input to the team to assist with EC or CA issue resolution at the country level.
• Works with 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. Produces site-specific contracts from country template. Submits proposed contract and budget for site.
• Works with contracts lead to agree on site-specific country template contract and budget. Produces site-specific contracts from country template. Submits proposed contract and budget for site. Negotiates budget and contract with site and via contracts lead with Sponsor until resolution of issues and contract execution.
•BA/BS degree in the science/health care field, legal degree, or equivalent combination of education and experience.
•Moderate clinical research or related experience.
•Knowledge of and understanding of the overall drug development process.
•Ability to develop, organize, and manage multiple tasks.
Industry Type: Pharma
Functional Area: Regulatory Specialist
Last date: 10th April, 2017
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