Sr SSU & Regulatory Specialist

Job Description

*Senior Site Start-Up & Regulatory SpecialistCome discover what our 25,000+ employees already know: work here matters everywhere. We re a growing and evolving biopharmaceutical industry leader, which means you ll have endless opportunities to work with experts around the world and build the career you ve dreamed of. As a part of the Syneos Health team, you ll help us deliver results for a rewarding reason we improve patients lives around the world. Because to us, a patient isn t just a number, they re our family, friends, and neighbors.Why Syneos Health #SyneosHealthLife means we re committed to our Total Self culture where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person s unique contributions make a difference. We believe our success is a direct result of the people who are driving it you We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives we re able to create a place where everyone feels like they belong.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 Standard Operating Procedures (SOPs) and Work Instructions (WI) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance. Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements. 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.). 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 (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., *What we re looking for Bachelor s Degree5+ Years of expereince in SSU EC Submissions, RA Submissions, IRB Submissions related activities for India and APAC Region countries Excellent understanding of clinical trial process across Phases II-IV and ICH GCP Good understanding clinical protocols and associated study specifications Excellent understanding of clinical trial start-up processes Project management experience in a fast-paced environment Good vendor management skills Strong organizational skills with proven ability to handle multiple projects Excellent communication, presentation and interpersonal skills Quality-driven in all managed activities Strong negotiating skills Strong problem-solving skills Ability to mentor, lead and motivate more junior staff Demonstrate an ability to provide quality feedback and guidance to peers Contribute to a training and Quality assurance plan within SSU and update SOPs/WIGet to know Syneos Health We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.Additional Information: 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. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. 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.

Keyskills :
clinical protocolsproject managementaudio masteringmanagement skillsnegotiation skillsvendor managementsite selectionquality controlline managementstatements of work sow