中文

Position Title:Project Manager / Senior Project Manager
Department:Project Management
Location:Shanghai or Beijing or Guangzhou or multiple locations

Position Summary

Responsible for simultaneous delivery of the operational aspects of single/multi-center clinical studies from Study start up through study close out 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 Project manager also contributes to support effective study reporting; 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 Project Manager or Senior Project Manager will reflect their level of experience and contribution that they can make to the project.


Key Responsibilities

Across Entire Study:

  • Manage overall project execution, progress, quality control and risk management. Keep good communications with sponsor and provide regular report on the study progress, and escalate the issue with action proposal when necessary
  • 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
  • Proactively identify and resolve study operation-related issues as they arise
  • Develop study management plan to ensure the clinical study operations to meet the time, quality & cost targets consistent with the plan-reached agreement with sponsor
  • Ensure that 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:

Protocol Development (if applicable)

  • Provide input to the protocol to ensure operational feasibility
  • 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
  • Produces study level ICD, as appropriate

Study budget

  • Provide input to generation of a study budget plan provided to the client
  • Review and control clinical trial budget within scope of budget plan

Data Management and Programming Interactions

  • Support programing, data management to ensure set up of data capture tools (CRFs and EDC system, data management plan, 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

  • Oversee site selection progress and ensure appropriate site selection
  • Develop site start up plan and oversee site start up progress to ensure site readiness within planned timeline (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 study Monitoring Plan; ensure CRAs, sites and the other relevant functional lines are trained on Protocol-Specific and the aspects of the Study Monitoring Plan.
  • Drive and/or contribute to investigator meeting strategy/agenda review meeting materials, facilitate and present at investigator meeting as required by sponsor
Clinical 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/Retention

  • Develop and adjust study level subject recruitment/retention strategy or plan, oversee implementation of plan, take appropriate action to ensure targets are archived within timeline

Quality & Compliance Management

  • Periodically review protocol deviations and collaborate with clinicians to manage protocol deviations according to dMed SOPs.
  • Proactively identify issues and take CAPA in a timely manner. Escalate findings and action plans to appropriate parties and 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) 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 management 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
  • Accountable for study close out; support Data Management function in database lock and release activities, ensuring all timelines and quality goals are met

Education and Key Competency Requirements

Professional Experience & Education Requirement

  • Minimum Medical or pharmaceutical education background or other life science degrees (or equivalent); experience in clinic practice is preferred
  • Minimum 3-5 years of experience in clinical trials as CRA, including at least 1 year involved in project management or equivalent, and present excellent performance and good potential to be a Project 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 Project Manager, shall possess the mature capabilities of Project 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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