Associate Biometrics Delivery Lead

Job Purpose:

• ​The Associate Biometrics Delivery Leader (ADL), reporting into the Global Biometrics Account lead (GBAL) or Global Biometrics Group Lead (GBGL) works under the guidance of an experienced Biometrics Delivery Leader (DL) or Line Manager receiving clearly structured directions and support and may have a client facing role.
• The Associate Biometrics Delivery Leader provides overall leadership/management for database programming, data integration, data management and statistical services on a project/program.
• The Associate Biometrics Delivery Leader takes on the Biometrics Delivery Leader responsibilities for the assigned selected tasks while the overall responsibility for the management of the Data Operations activities remains with the Biometrics Delivery Leader / Account Lead.
• The Associate Biometrics Delivery Leader may work in a Biometrics Delivery Leader role (with support from the Line Manager) for reduced-scope projects.

Key Accountabilities

GDO Strategic Support:

• 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
• 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.

Team Management:

• Support Account Lead / Delivery Lead with Bid Defence meeting preparations as directed
• Understand scope of 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
• 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
• 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
• Monitor KRIs, propose DL-led risk signal evaluations, and perform associated milestone document TMF reviews
• 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
• 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 internal 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
• May participate in client, investigator, and team meetings with support from the Delivery Lead / Account Lead
• 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)