Global Biometrics Delivery Lead

3 weeks ago

King Of Prussia, United States Parexel International Corporation Full time
  • Provide a range of leadership and influencing capabilities to achieve the business objectives and goals for both Parexel and clients
  • Effectively communicate with internal and external customers as well as third party vendors
  • Participate in cross functional meetings and support initiatives to ensure the delivery of milestones and timelines for clinical trials
  • Ensure all systems both technical/non-technical are set up for complex projects/programs
  • Responsible for the creation and execution of a project timelines plan covering all GDO deliverables; this includes the coordination of dependencies between Data Operation stakeholders (Data Management, Programming, Biostatistics) either within Parexel or at a client
  • Work with study teams and Data Standards Associates to ensure enforce the use of data standards as applicable
  • Provide technical knowledge and oversight and serve as an escalation point where appropriate.
  • Remain informed about developments in relevant regulations and guidelines.
  • With assistance provide input to proposals and attend Bid Defense meetings as required
  • As needed and with guidance, participate in a meeting with Business Development/CDD/PL/PM to understand the scope of the contract and any Master Service Agreement in place for the client
  • Ensure the operational team reviews the draft protocol from a Data Operations perspective
  • Attend project kick off meetings and other project related meetings
  • Identify and request staff necessary for the project team
  • Review and collate information required for the project tools, project plan, TMF, resourcing, etc. in collaboration with the PL/PM.
  • In cooperation with the PL/PM accountable for the deliveries from the technology/data integration team (if applicable)
  • Accountable for ensuring all team members access to tools and documents as required
  • Ensure information entered in internal management systems is accurate and updated on a regular basis
  • Establish efficient/effective working relationships with other functional leaders and experts
  • With assistance provide leadership and direction to the project team members
  • Communicate project metric targets to the project team members and guide team towards achieving them
  • With little oversight ensure the project is completed within budget, schedule, and according to contract specifications
  • Ensure the project is progressing according to quality standards, SOPs, ICH and/or other guidelines to fulfil regulations
  • Perform early risk mitigation, identifying areas of potential problems providing input into Risk Management Plan
  • Track resources and actual time spent on each project task for all team members to evaluate project progress and productivity
  • Record and measure progress of the study against project plans to mitigate risk and ensure updates are made accordingly
  • Determine the cause of project overruns, recommend and institute corrective action, with input from functional experts, escalate and follow up as appropriate
  • Implement and instigate process improvements within the project
  • Work with functional experts to track scope of ongoing work to identify changes in scope in a timely manner
  • Hold team meetings on a regular basis, monitoring the progress of each individual project task, and assessing the overall status of the project
  • Ensure maintenance of Data Operations project documentation on an ongoing basis throughout the course of a project
  • With assistance provide performance feedback on team members as appropriate
  • Participate in client, investigator, and team meetings
  • Prepare, participate in, and follow up on audits/inspections/QIs
  • Collaborate with Data Operations team, the Clinical Operations Leader, and other functions on project close out activities
  • Ensure all administrative close out procedures are completed on the project
  • Ensure project is archived and appropriate documentation returned to the client
  • Participate in end of study meetings and collate lessons learned information and feedback relevant information into the functions
  • Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements and Parexel SOPs and study specific procedures
  • Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel expense claims)
RequiredPreferredJob Industries
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