Global Biometrics Delivery Lead

The Biometrics Delivery Lead (DL), reporting into the Global Biometrics Account Lead (AL) or Global Biometrics Group Lead (GBGL), has overall accountability for the execution of the Data Operations strategy and the Data Operations technology set up for the project.  The DL provides overall leadership/management for database programming, data integration, data management and statistical services on a project/program.  General areas of responsibility include oversight of the Global Data Operations team members and their activities across all geographies, liaising with the AL, other functional leaders (both in GDO and across Parexel), and the client as a single point of contact to ensure that the Data Operations deliverables regarding timelines, resourcing, quality, and productivity are being met. The DL will be responsible for managing budgets and resourcing for assigned studies.   The DL may take on some AL responsibilities for projects involving a small number of services, where no account lead is assigned.

Provide an extensive 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.  t•Provide an extensive 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  •With assistance 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)