Parexel International Corporation
Global Biometrics Delivery Lead
Parexel International Corporation, King of Prussia, PA, United States
- 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)