Senior Biometrics Delivery Lead

Accountability Supporting Activities

GDO Strategic Support

• 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 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. Team Management

• 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)