医药类招聘信息汇总-第7页高八斗搜职

广州道翔商务服务有限公司 (高级)临床监察员Clinical Trail Monitor Primary Responsibilities include: As a Clinical Trial Monitor: Conducts Pre-Study Site Management Activities Contributes to the site and investigator selection process for their area of responsibility by making appropriate recommendations Partners with Roche Business colleagues to identify potential investigators Provides site-level information for the country recruitment plan, including past and potential site performance and feasibility Evaluates site facilities and staff to ensure that investigative site meets ICH – GCP guidelines, local regulatory requirements, protocol and Roche specific criteria for study conduct Ensures subject informed consent(s) and protocol are approved by the applicable local Ethics Committee(s) and informed consent processes at site are in place Assists and provides feedback on sites issues during site contract development and negotiation process (where applicable to the Roche Affiliate) Ensures all required study start-up documentation is in place and the site is able to start on time and according to plan Provides feedback on monitoring related issues during development of the monitoring plan Participates in the investigator meeting and monitors workshop Oversees and Facilitates Study Start-Up Activities Performs & facilitates study start-up activities with the investigational site to ensure all the necessary arrangements are in place prior to study conduct Builds and maintains positive relationships with the site and investigators so that Roche can meet its business needs in the short and long term Communicates in an effective, consistent, and timely manner so that the site’s needs are met and the site is in a position to deliver quality data and comply with GCP, local regulations and protocol-specific requirements Takes ownership of site issues that arise during start-up phase and ensures they are appropriately resolved Assists in implementing country-level communication plan for study sites and executes the site communication plan Develops and implements site recruitment plan with input from investigator, affiliate local study team and in alignment with the country-level recruitment plan Carries out monitoring activities at the site during the study start-up phase to ensure all the necessary arrangements are in place including conduct of the initiation visit Designs a site-level recruitment plan with the input of the investigator, in alignment to the country-level recruitment plan Performs required site training in a range of areas to ensure investigators and site staffs are prepared to conduct the protocol according GCP, local regulations, and Roche-specific criteria and processes Plans, executes and documents site study-specific training in a range of areas in order to ensure investigators and site staff are appropriately trained and able to deliver quality data and in compliance with GCP and applicable regulations Ensures the site have appropriate supplies, both drug and non-drug, needed to conduct the clinical study Performs on- and off-site monitoring activities during study conduct to ensure adherence to Protocol, ICH-GCP guidelines and local regulatory requirements are met and Data Quality standards for Clinical Trials are met Conducts on-site visits and monitoring activities in line with the monitoring plan During the site visits ensures adherence to ICH - GCP guidelines and local regulations, the adequacy of the facilities and personnel for study conduct, adherence to protocol, reporting of protocol changes to IRB/Health Authorities, maintenance of adequate and complete records, and reporting of timely, accurate data to Roche/IRB/Health Authorities Perform SDV during on-site monitoring visits according to the protocol SDV plan Verifies complete and accurate reporting of SAE/Pregnancy Forms Ensure site is receiving all safety information from Roche (SUSAR and QSR reports, as per local regulations, and Investigational Brochures) and is submitting these reports, as appropriate, to the local ethics committee Evaluates site recruitment activities (at least monthly) per the site-level recruitment plan during enrollment phase and addresses recruitment issues and/or needs with site staff on an ongoing basis Verify site is transmitting data to Roche and resolving discrepancies according to agreed upon timelines Assesses ongoing training needs of all site personnel and takes appropriate actions to ensure necessary training is performed in a timely manner Writes and submits timely reports/correspondence to document site management activities and findings as per monitoring plan Performs site-level drug accountability and reconciliation activities to ensure proper handling, storage, administration, record-keeping and disposition of study drug(s) per GCP, local regulations, and protocol Raise and close monitor discrepancies Verifies storage and shipment of biological samples and other protocol specific diagnostics requirements Updates and reviews the CTMS system regularly to ensure that site-specific details and data are current Performs off–site monitoring activities between site visits, after site visits and according to monitoring plan Submit essential documents to archive, reconcile documents sent/received to archives, assess study progress, review electronic data and raise/close monitor discrepancies, as appropriate, assess staff/facility changes, assess need for more study supplies, follow-up monitoring visit action items, and prepare for upcoming monitoring visits by accessing available electronic tracking systems - (EDC, Monweb, CDC, CTMS and Hyperion reports, SDE) Attends site audit and executes site audit action plan Conducts Study Site Close-Out Activities Ensures proper return and disposition of all study-related supplies and equipment Performs and verifies final reconciliation of essential documents between investigator files at site and Roche archives Performs final site-level drug accountability and reconciliation and ensures return/destruction on local level Ensures archival CD containing patient data is delivered to site and archived appropriately Ensures investigator understands requirements for archiving the investigator files and has the capability to archive for the designated period of time Identifies Areas of Best Practice and Process Improvements Contributes to activities to improve and maintain the quality and effectiveness of processes and activities within the function Provides input to and carries out site and monitor training on study-specific and therapeutic-specific areas As a Clinical Trial Monitor Who Takes the Project Leader Role: Provides Direction and Leadership to one or more LSTs Sets the LST goals and ensures goals are in line with the operational strategy agreed by Clinical and Study Management Teams. Provides coaching to the team to facilitate the setting and achievement of goals Ensures that each team member is aware of his/her specific area of accountability and responsibility within the LST Manages and coaches performance of study team members by setting expectations, supporting team members, monitoring performance, providing feedback and following up, when appropriate to ensure performance is optimized Establishes Study Timelines, Budget, Resource, Risk and Quality Plans In accordance with the overall project plan, establishes and maintains accurate study level plans in Pharma Planning System, (PPS) Develops country/regional level study timelines and ensures that milestones are set and managed for the overall studies delivery in association with the GSOM and/or functional managers Develops and manages Affiliate budget/financial plan, and forecasts using appropriate tools, ensures the LST(s) has the appropriate resources to effectively deliver high quality studies on time and within budget Responsible for ensuring site level contracts are completed Provides input on local requirements for biologic sample plan to the Global Biosample Specialist, and organize biological sample exporting for the whole study In collaboration with the GSOM and/or functional managers, and where necessary, PDQ, develops and executes the local implementation of the audit quality and risk management plans identifying critical issues for the Affiliate and ensuring contingencies are established and captured in the study level risk management plan. Ensures that the plans are reviewed and updated over the course of the studies Develops local LST communication plan Is accountable for the development and active management of the study patient recruitment strategies in the Affiliate Develops country recruitment plan for the affiliate and manages patient recruitment strategies Manages the Delivery of Study Activities in Order to Meet Study Plans Is accountable for the selection, training and management of external suppliers supporting the Affiliate Is accountable for all Affiliate ethical and administrative submissions Design and implement a country level training plan to ensure that team members and investigators receive training on the protocol, ICH/GCP requirements, and applicable Roche process/procedures Ensures protocol adherence and consistency of study processes and procedures across all Affiliate investigational sites Ensures studies in the Affiliate are performed and conducted in compliance with ICH-GCP guidelines, Roche SOPs, local operating guidelines and all applicable regulatory requirements Ensures patient safety and data quality maintained, and that any concerns are escalated appropriately Ensures monitoring reports are timely reviewed and takes appropriate actions for follow up on site issues Ensures that data is delivered in accordance with established dataflow timelines Ensures that trial management tracking tools (e.g. AIMS/CTMS/SDE) and systems are populated and maintained Develops/maintains investigator relations, builds and maintains a professional relationship between Roche and Investigator, participating in Affiliate Investigator Meetings as necessary Leads and/or organizes (or assists in organizing) and/or participates in local or regional meetings and training sessions (i.e., LST meetings, Investigator Meetings, Monitor’s Workshops, and CRO training.) Implements the country-level recruitment plan Monitors progress against LST goals and takes appropriate action to ensure goals are met and issues are communicated with the appropriate persons or teams Chairs LST meetings, ensuring appropriate follow-up is taken on action points Provides the SMT (via the GSOM and/or functional managers) with regular status updates with regard to Affiliate recruitment and investigational sites Communicates regularly on country/region study(s) status and escalates unresolved issues appropriately to the Country Head, the GSOM and/or functional managers Ensures use of site recruitment plans Maintains tracking of study status Oversees the management of the local affiliate studies budget Qualification and Experience: Education and relevant working experience: University degree or equivalent in a medical/science-related field and/or 5 years proven experience in Clinical Research/ Development or related industry Requirements on specific subject(s): Demonstrated ability to interact with different professional levels of the medical community The ability to function independently without minimal or no daily supervision, particularly if located remotely from their management Experience working as part of a team with a proven ability to make an active contribution to the team's performance and teamwork Able to anticipate, trouble-shoot and resolve various types of problems for instance to move actions forward and ensure conclusion Proven organizational skills and the ability to prioritize and manage multiple tasks to a successful conclusion Possesses the ability to manage multiple study sites in one or more therapeutic areas Able to motivate study personnel to accomplish study objectives Analytical and conceptual thinking skills – is able to critically evaluate and solve problems, display good judgment, and maintain appropriate levels of independence Basic understanding of and competency in data flow and electronic tracking systems Willingness to travel (up to 75%) of working time (includes overnight and or international travel as necessary) Language: Demonstrated ability to communicate clearly and accurately in both written and spoken English Computer skill: Proficient in various computer applications including spreadsheets, email, word processing software and databases Other skills and/or competence: Attention to detail Self-motivated, tenacious and displays initiative The statements made here are intended to describe the general nature and level of work being performed by people assigned to this job. These statements are not intended to be an exhaustive list of all responsibilities, duties and skills required of people assigned to this job. 公司提供有竞争力的薪酬水平和长期稳定的工作发展空间。请把握好恰当时间为你自己创造更广阔的职业发展机遇，利用好信息不对称原理，联系我们，为你带来意想不到的机遇！请发送简历到专用的简历信箱hr@chinadox.com（简历和客服专用电邮），我们的专业人员会严格保密所有你的信息。 hr@chinadox.com（发送简历和客服专用电邮） 不限广州市环市东路368号花园酒店写字楼718室