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CRHF_Prin Clinical Research Specialist_SH


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CRHF_Prin Clinical Research Specialist_SH Jobid medtronic2-27688 Location: Shanghai, CHN Description CRHF_Prin Clinical Research Specialist_SH Location: Shanghai, Shanghai, China Requisition #: 170006S4 Post Date: Oct 17, 2017 **KEY ACCOUNTABILITIES:** Establishes Study Timelines, Budget, Resource, Risk and Quality Plans synopsis, development of the final protocol, feasibility conduct and all study specific documents and procedures 1). Develop study synopsis, protocol, feasibility conduct and all study specific documents and procedures 2). Oversees project, protocol and site feasibility and determines site selection and patient allocation 3). Based on project chart, prepare integrate project plan to set study timeline, budget, resource, quality and risk. a. Develops country level study timelines according to the result of protocol/site feasibility b. Establish country-level recruitment strategy/plan c. Develops budget plan, and forecasts using appropriate tools, ensures the study team has the appropriate resources to effectively deliver high quality studies on time and within budget d. Develops resource plan according to sites and patients allocation e. Develops study communication plan and monitoring plan f. In pre-market study, sets study drug management plan Manage the Delivery of Study Activities in Order to Meet Study Plans 1). Generate clear work breakdown structure to make each study member understand his responsibility 2). Ensure study progress is in accordance with baseline project timeline a. Is accountable for timely achievement of key study milestones(EC approval, site initiation, first patient first visit, last patient first visit, last patient last visit, data frozen, etc.) b. Prepare and conduct outsourcing vendor selection. Act as a key contact with outsourcing vendor for proposal, interview, evaluation and contract. Submit vendor evaluation form for final approval c. Prepare proposed site lists and patient allocation d. Device management (pre-market trial): ·Complete device rolling forecast within request leading time ·Continuously review device status report and ensure its accuracy e. Safety management: ·Ensure SAE reporting to PI/EC according to regulatory timeline and procedure ·Complete SAE reconciliation according to the timeframe f. Propose the contents of the investigator meeting and assign respective responsibility in the meeting among study team g. Review and approve study related contracts (with external vendors or with sites). h. Establish and update study country information in CTMS i. Chair regular project review meetings where study progress and quality issues could be discussed and resolved j. Ensure to setup and maintain trial master file 3). Supervise the conduct of the study is in accordance with quality plan a. Ensure studies are performed in compliance with protocol, ICH-GCP guidelines, Medtronic SOPs, local operating guidelines and all applicable regulatory requirements and quality plan b. Leads and/or organizes (or assists in organizing) and/or participates in local or regional meetings and training sessions (i.e., Investigator Meetings, Monitor’s Workshops, and CRO training.) c. Monitor key risk indicators which have been identified in quality plan. Ensure patient safety and data quality concerns are escalated and resolved appropriately (e.g. non-compliance in monitoring visits or AE occurrence) d. Review information uploaded to CTMS and project tracking tools. Query and correct any deviation or incomplete information e. Ensure monitoring reports are timely, reviewed and takes appropriate action for follow up on site issues f. Conduct co-monitoring visits in align with quality plan or for cause during the study. Complete co-monitoring reports and supervise monitor to correct g. In case of any quality deviation or other issues, lead study team to identify the route cause and to make follow up actions until resolution h. Draft any possible slides or posters in study training or results delivery, including the slides or posters presented at domestic or international conferences. 4). Oversee the management of the studies budget a. Ensure study expense is within reasonable variance of approved budget b. Review medical study expense reports and SAP study expense reports. Ensure each payment is accurate and is timely c. Supervise study expense to ensure its compliance with approved budget d. In case of any variance during the study, adjust budget phasing at least quarterly, however reasonable explanation should be provided e. Timely complete accrual form according to FA requirement 5
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