Manager of Clinical Data Management

Highly Competitive
  1. Permanent
  2. Data Management
  3. China
Shanghai
Posting date: 25 Jul 2019
SS.SQ.24510_1564063878

An international contract research organisation (CRO) is looking to recruit a Manager of Clinical Data Management to their office in Shanghai. The organisation is known for providing expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. This role offers an exciting opportunity to bring expertise and skill to a job with a company that makes a difference in the development of the pharmaceutical industry.

Job Responsibilities:

  • Is the primary contact person for day to day data management activities, and is the person ultimately responsible for all data management deliverables for assigned projects.
  • Plan and implement data management timelines and deliverables; and is responsible for providing database and data management activities status reports; contributes to the overall project planning, progress tracking and reporting. Is the primary contact person for request for out of scope tasks; first line contact for technical or procedural issues.
  • Perform study-level resource planning and management, including the review of team members' timesheet reports.
  • Participate in project kick off meeting, investigators meeting, and regular project management team meeting.
  • Develop and maintain Data Management Project Plan (Plan). Document deviations from the Plan, log and report issues, and follow up on their resolutions.
  • Design and review case report forms (CRFs/eCRFs). Develop and review Case Report Form Completion Instructions. Generate and review annotated Case Report Forms.
  • Design and review Clinical Trial Source Document templates and completion instructions when required.
  • Develop and maintain data validation specifications.
  • Coordinate database design process and lead User Acceptance Testing (UAT).
  • Manage the process of database modifications after go-live.
  • Perform training on electronic data capture (EDC) system, dataflow and quality control processes to clinical trial personnel.
  • Provide training to new data management personnel on data management processes and procedures. Perform QC review of work performed by less experienced data management personnel.
  • Develop and maintain Data Quality Review Plan (DQRP). Coordinate with programmers to complete the programming and validation of the listings and summary tables as specified in the DQRP.
  • Review data, issue and resolve queries.
  • Perform Serious Adverse Event reconciliation.
  • Assist in resolving medical coding discrepancies.
  • Perform management of dataflow and quality of data from the Third Party Vendors (Non-CRF data vendors).
  • Perform database soft lock and hard lock activities.
  • Assist in performing client relationship management activities. Participate in project bid defense meeting when required.
  • Assist in generation of project Work Orders and Amendments.
  • Cooperate and assist internal and external audits on assigned projects.
  • Maintain and prepare final archival of data management documentation relevant to the assigned projects, and assist the corporate archivist in assembling and archiving such documentation.
  • Manage the EDC CRF to PDF CRF conversion process for generating regulatory submission-ready CRF packages.
  • Lead effort in the further development and implementation of a "real time" data and trial information portal/dashboard with standard and custom reports covering the following: reports for data managers and safety data reviewers, reports on site performance, risk factors and scores, patient profiles, reports for data trending and pattern recognitions, etc.

Skills and Requirements:

  • A Bachelors' or Master's degree in health and/or pharmaceutical sciences, physical/biological, or chemistry fields.
  • At least 5 years of experience in pharmaceutical clinical trial data management or at least 2 year of experience as a Clinical Data Manager II, with demonstrated knowledge, experience and ability to perform to meet high quality standards and high level of customer satisfaction.
  • Demonstrated an in-depth understanding of clinical trial data management concepts, processes and procedures, relevant issues related to or impacting clinical data management, as well as pharmaceutical clinical trial regulations, industry guidance, conventions and standards.
  • Demonstrated a strong leadership in clinical data management activities and a desire to excel in leading data management projects.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Stephen Qin at +86 21 51694107 or upload your CV on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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