client banner -Job details -Clinical Support Specialist -Requisition ID:WD179661 -Position:Full time -Open date:Aug 22, 2018 4:56 PM -Functional area:Medical and Clinical -Location: Collegeville, Pennsylvania -Required degrees:Associates -Experience required:Not Indicated -Relocation:Not Indicated -Your Responsibilities: The primary objective of this position is to provide operational support to the clinical trial process. Working to a core set of activities according to GSK operating standards and good clinical practice; ensuring studies receive the support needed to meet or exceed customer expectations on time and within budget. Including ensuring accuracy of clinical study systems. Supporting Global GSK Sponsored and Supported R&D Trials, Phases I - IV. Interacts with internal matrix partners and external partners (e.g., Investigators, sites and vendors). Provides operational support directly or by supporting teams, on studies at the, Global/Regional, Country and Investigator levels. Serves as point of contact for study support questions for internal and external customers for assigned study(s) (e.g., support feasibility and site recruitment process, submission for central ethics approval, tracking of regulatory, financial and legal documents, study systems, etc.). May be responsible for supporting multiple studies simultaneously and must prioritize appropriately to meet business needs to ensure delivery of results. Responsible for the accuracy and integrity of data within GSK study systems and entry of information to support studies. Active participant of clinical study teams as appropriate. Develop/assist study specific processes and procedures for operationalizing studies, adhering to standardization, and dissemination of best practices. Oversee study related logistics, resolve complex requests, recognize underlying issues, and communicate issues and proposed solutions as appropriate. Enable compliance with both GSK SOPs, Policies and external regulatory requirements to ensure study records are collected, maintained and archived according per current processes. Ensure consistency in study support practices across therapeutic areas and programmes in addition to clinical trial, as appropriate. Responsible for study file review audits, including report and resolution of findings. Relevant documentation in place, quality checked and tracked to meet required regulatory guidelines for study conduct. Adhere to GSK processes and procedures, SOPs, ICH and GCP guidelines in conduct of clinical studies to meet established timelines, milestones and study objectives. Quality of data in GSK study systems to ensure accurate and timely planning, monitoring, execution and reporting of clinical studies. Best practices are shared and implemented internally and externally and serves as a change agent for GSK. Review and track study invoices and accruals, including resolution of investigator grant payments, invoice accuracy, comparison to contract and outstanding payments, as applicable Project and allocate external study expenditures relevant to clinical support activities (e.g., Health Care Professional (HCP) meetings, vendors) Proactively interpret, draw valid conclusions, and summarize information from systems to support studies, including the development of complex/innovative information management solutions and systems. Able to suggest and/or develop methods for reporting from GSK and vendor systems for centralized planning and tracking. Demonstrates strong communication and negotiation skills that strategically influence internal and external partners to ensure that they have current and accurate information regarding study activities. Partners include Investigators, site personnel, Global Study Team, vendors, GSK Senior Management and Internal GSK Matrix Partners. Engage and liaise with TATA Clinical Services (TCS) on specific study level activities. Participate in process improvement initiatives as required. *LI-GSK Why You? Basic qualifications: Associates Degree or equivalent experience 3-5 years Experience in pharmaceutical industry or health related field Proficiency in multiple software applications Comprehensive knowledge of the clinical development process and FDA/ICH/GCP regulations Able to perform study-related tasks with minimal or no oversight Preferred qualifications: 5+ Experience working on multiple clinical studies, including complex projects assignments in a matrix environment. As applicable, experience training or mentoring staff in Clinical Development processes and procedures and FDA/ICH/GCP guidelines. As applicable, experience overseeing or leading teams for complex initiatives or multiple study projects. Experience independently managing projects and assignments, including assuming full accountability for delivering results. Why GSK?: GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Contact information: You may apply for this position online by selecting the Apply now button. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity/Affirmative Action Employer. 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