Associate Data Management Lead
Parexel
China - Beijing - Beijing
1天前

Key Accountability

  • Provide leadership to ensure the project or program is completed within budget, schedule and according to contract specifications.
  • Ensure the project / program is progressing according to quality standards, SOPs, ICH and / or other guidelines to fulfill regulations (including oversight and maintenance of relevant data operations project documentation).

  • Must manage time, and understand financials, maintain focus on quality, balancing deadlines with ensuring high quality output
  • Thorough knowledge of numerous EDC systems (DataLabs, InForm, Rave.)
  • Thorough knowledge of electronic source data capture systems (e.g. ClinBase)
  • Thorough knowledge of the eClinical suite and additional tools and systems that can be integrated with a particular EDC system ( MyTrials, IVRS etc ) and Reporting functionality within the EDC system )
  • Thorough knowledge of all DB set- up activities including but not limited to Database Configuration Specifications, Data Validation
  • Thorough knowledge of all activities during Study Maintenance and Database Lock. Review of metrics to determine risks and risk mitigation plans as required
  • Effectively communicate to and manage internal project teams, external customers and third party vendors. Hold team meetings on a regular basis.
  • Participate in client, investigator and team meetings.

  • Ensure interdependencies are understood, anticipate potential barriers or issues, and put plan in place with appropriate countermeasures
  • Effectively manage contracted project delivery. Highlight issues / risks to delivery and mitigate risks for both PAREXEL and the client, developing contingency plans for the project (or providing input to PL).
  • Accountable for quality control of project deliverables and timely delivery of projects.

  • Manage appropriate project level resourcing of staff and staff assignments. Identify and request staff necessary for the project team.
  • Ensure information entered into management systems is accurate and updated on a regular basis.
  • Review metrics reports regularly, determine the cause of any project overruns, track scope of ongoing work to identify and raise CIS in a timely manner.
  • Participate in cross functional meetings and drive initiatives, participate in Business Development and BID Defense meetings as required.
  • Prepare, participate in and follow up on audits / inspections.
  • Participate in meeting with Business Development / PFD / PL to understand the scope of the contract and any Master Service Agreement in place for the client
  • Collaboration with the Clinical team to review the ClinBase setup performed by the pharmacy, safety Laboratory team and Clinical Database Designer.
  • Qualifications

  • English capability.
  • CRO experience.
  • 4-5 years of DM experiences.
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