Study Start Up Specialist II/Sr-Wuhan

When our values align, there's no limit to what we can achieve. At Parexel , we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel , contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Key Accountabilities :   SSU Coordination and Execution   Coordinates, guides, and assists with all start up activities prior to site activation, including but not limited to: Site Informed Consent Form (“ICF”) localization and guidance in line with regulatory/health authority requirements. Ethics Committee (“EC”) information, meeting dates & costs. Ethics applications & associated online systems. Ethics & Governance submission processes. Clinical Trial Health Authority application and regulatory submission process. Contracts & Indemnity request process. For global studies, localize global ICF with country requirements. Local sample application and permit submission processes  Maintains up to date knowledge, ensuring adherence and compliance with local regulatory requirements and associated documentation  Reviews, analyzes, and collates metrics to ensure processes are in place that drive efficiency and reduction of timelines across start up and contracts negotiation  Ensures all start up information & requirements are kept up to date in a central repository for both global and local study teams  Assists with label preparation and approval (local label representative) for studies in collaboration with local regulatory department  Tracks metrics and SSU timelines to identify trends and opportunities for improvement  Relationship management   Liaises and collaborates with relevant authorities/bodies to further enhance clinical trial processes, government policies/laws, via innovative approaches  Maintains current, and awareness of changes in, startup processes across government, hospital & industry & liaises with stakeholders to resolve any SSU issues  Proactively responds to information survey requests by government/ industry bodies  Provides continuous and proactive communication with ECs/hospital administration/industry bodies to obtain accurate and up to date information on clinical trial status and activities  Maintains communication with local legal/regulatory/clinical operation to ensure input is sought and all internal/external requirements are met  Provides guidance to Country Study Managers (CSMs) and Country Study Specialist (CSS) on regulatory/ethics, tracks & drives site activations by regular review and monitoring status of submissions/ activations  Collaborates with vendor management and procurement to provide input as required into vendor identification, selection, and Request for Information (RFI)/ Request for Proposal (RFP) process  Liaises and shares best practices with other SSU within the region/organization  New Site Identification   Assists with identification and tracking of new sites in collaboration with CSMs  Performs/coordinates site level feasibility activities including evaluation of patient population and final site selection  Contracts/ Budget   Negotiates contracts and study budgets with sites during the SSU phase to ensure finalization  Provides local fee structures and budgetary advice as required and ensure compliance to Fair Market Value (FMV) in the country  Collaborates with CSMs to maintain data to ensure FMV  Liaises with management/CSMs to implement budget cost containment and implement contingencies as required  Compliance with Parexel standards   Complies with required training curriculum   Completes timesheets accurately as required   Submits expense reports as required   Updates CV as required   Maintains a working knowledge of and comply with  Parexel processes, ICH-GCPs and other applicable requirements  Skills:   Demonstrated competence in analysis, planning and problem solving.  Excellent communications including the ability to state opinions clearly, ask questions, seek clarification, communicate facts objectively, challenge when appropriate, and pursue issues to resolution.  Ability to present clear messages from complex information/data to all levels in the organization in both written and spoken English.  Ability to make effective decisions.  Proven project management and organizational skills and the ability to prioritize and manage multiple tasks with flexibility.  Demonstrated teamwork and ability to make an active contribution to team performance.  Demonstrated computer literacy, to usage of MS Office software, web-based systems, and databases.   A flexible attitude with respect to work assignments and new learning.   Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.  Willingness to work in a matrix environment and to value the importance of teamwork.    Knowledge and Experience :   >1.5 years of proved SSU experience in clinical trials, experience in global company is preferred.   Demonstrated knowledge and understanding of ICH-GCP, the regulatory, ethics and contractual requirements for starting clinical trials in China.   Achieved a satisfactory level of technical, functional, and/or professional skill/knowledge in position – related areas; keeps up with current developments and trends in areas of expertise; leverages expert knowledge to accomplish results.    Education:   University Degree or equivalent preferably in a medical/science-related field.      Originally posted on Himalayas