中文

Position Title:Study Manager/Senior Study Manager
Department:Clinical Operations
Location:Shanghai

Position Summary

Responsible for simultaneous delivery of the operational aspects of a single/multicenter clinical studies from protocol development through database release to ensure high quality, timely and cost effective conduct of the clinical trials. Ensure the study conduction in accordance with ICH-GCP, local regulatory requirements, and the Standard Operating Procedures (SOPs) of Sponsor and /or dMed. The Study manager also contributes beyond database release to support effective study reporting and close-out; submission activities; and audits/inspections, as appropriate. He/she achieves this purpose by thoroughly understanding protocol and actively managing the activities and deliverables of all study conduct. The degree of responsibility accorded to a Study Manager or Senior Study Manager will reflect their level of experience and contribution that they can make to the project.

Key Responsibilities

Across Entire Study:

  • Keep good communications with sponsor and provide regular report on the study progress, and escalate the issue with action proposal when necessary; Study overall project management, status tracking and proactively anticipate and resolve issues.
  • Actively manage the activities and deliverables of sponsor and all study partners (Investigator sites, site management functional lines, clinical supply, sub-contractors) to ensure timely delivery of quality data on specific studies
  • Effectively manage and lead project team to deliver key clinical operation milestones for serviced studies
  • Oversee site management functional lines to ensure that protocol and monitoring plan are consistently and appropriately implemented across clinical sites. Collaborates with the sites and site management functional lines to ensure that they are provided with the information to effectively contribute to the study
  • Proactively identify and resolve study operation-related issues as they arise
  • Ensure the clinical study operations to meet the time, quality & cost targets consistent with the plan-reached agreement with sponsor
  • Responsible for the studies to be conducted in compliance with ICH-GCP, relevant SOPs, and local regulatory requirements; Responsible for inspection readiness for all aspects of the study conduct
  • Share best practices across the organization to ensure cross-line standardization
  • Study Start-Up

    Feasibility, site selection and study budget

  • Responsible to guide or lead CRAs to conduct both protocol and site feasibilities within a required timeframe and provide input to the study management components of the protocol
  • Ensure appropriate site selection for a specific study
  • Produces study level ICD, as appropriate
  • Provide input to generation of a study budget plan provided to the client.
  • Data Management and Programming Interactions

  • Support programing, data management to ensure set up of data capture tools (CRFs and EDC system, diary cards, questionnaires, translations etc.) to ensure completion within project deliverable timelines
  • Overall responsible for ensuring the study has efficient and effective data flows (for all types of study data, including SAEs, endpoints, patient diaries, lab data, etc.)
  • Site Selection and Start-up

  • Develop study level subject recruitment and retention strategy or plan, including study start-up timeline; oversee implementation of plan, including site-level plans, subject recruitment and retention strategy or tools, and advertising materials
  • Oversee sites and site management to ensure site readiness (Clinical Site Agreements, Ethics Committee approvals, HGRAC approvals and to meet other regulatory requirements, e.g. clinical registry)
  • Training and Investigator Meeting (as needed)

  • Develop the Monitoring Plan; ensure CRAs, sites and other site management functional lines are trained on Protocol-Specific aspects of the Study Monitoring Plan.
  • Work with Clinician to ensure that site management functional lines are provided with appropriate training in both the protocol and therapeutic area knowledge
  • Drive and/or contribute to investigator meeting strategy/agenda, responsible for overseeing implementation by the project team, and review meeting materials
  • Facilitate and present at investigator meetings, as required by sponsor
  • Drug Supply

  • Collaborate with sponsor supply line to develop and complete of the Request for Clinical Supplies
  • Work with sponsor’s supply line to ensure that clinical trial drug supplies are ordered, produced, labeled and supplied in a timely manner
  • Clinical Study Conduct

    Subject Recruitment and Retention

  • Manage protocol-level subject recruitment and retention and take action to ensure to reach timeline. Use trial projection and tracking metrics as tools to monitor and actively manage the delivery of project team’s goals.
  • Quality & Compliance Management

  • Periodically review protocol deviations and collaborate with clinicians to manage protocol deviations according to dMed SOPs.
  • Work closely with project team to ensure data quality requirements are agreed to and met, prior to reporting.
  • Perform required activities to identify issues and take CAPA in a timely manner. Ensure the sufficient documentation.
  • Work with the internal quality control, internal / external Quality Assurance and site to ensure high quality of trial. Coordinate with site audit or inspection (e.g. CFDA certification renewal inspection) if any and ensure the CAPA completion with the required timeframe.
  • Other related activities

  • Ensure the drug supply (including resupply) process timelines, risks and issues are handled in a timely manner. Ensure investigational drug logistics and drug countability at site to meet the requirements per protocol.
  • Work closely with the data management function to ensure data entry, query resolution at the protocol level. Take actions to ensure the milestone of data management, data entry, data cut-off, interim analysis, data cleaning, database lock
  • Vendor management and oversight if any sub-contractor is involved.
  • Well manage and control the study budget, and keep communication with sponsor if the budget needed to be adjusted
  • Clinical Study Close-out

  • In close partnership with the sites and site management functional lines to ensure site closeout activities including the self-assessment per regulatory requirements are completed,
  • Responsible for the collection and consolidation of the Protocol Deviation Logs.
  • Accountable for study close out; support GCDS in database lock and release activities, ensuring all timelines and quality goals are met.

  • Education and Key Competency Requirement
    Professional Experience & Education Requirement

  • Minimum Medical or pharmaceutical education background or other life science degrees (or equivalent); experience in clinic practice is preferred
  • Minimum 5 years of experience in clinical trials as CRA, at least 1 year involved in project management or equivalent, and present excellent performance and good potential to be a study manager
  • Good working knowledge of GCP guidelines and good sense to regulatory requirements
  • Proficiency in Basic Microsoft Word and Excel and familiarity with use of database
  • Broad knowledge of drug development process, and good relationship with investigators
  • For a Senior Study Manager, shall possess the mature capabilities of Study Manager. Capable and experienced in handling complex or difficult situations or projects to meet study goal. Has profound knowledge and capability to mentor or coach to junior & new members.

  • Key Competency Requirement

  • Organizational commitment and result Oriented
  • Self-awareness and self-motivated
  • Well-developed of communication (Chinese & English), presentation, and interpersonal skills
  • Teamwork and collaborative working attitude
  • Demonstrate thought leadership and innovative approach contributing to project outcome
  • Facilitation and influence skills with multiple parties involved
  • Project leadership and management skills with proven record; Capable to plan and prioritize to manage competing objectives
  • Strong problem solving and consultation skills Resilient in changing business environment, and able to drive and implement changes effectively and positively
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