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Senior Biometrics Delivery Lead

Parexel International Corporation

SHANGHAI, Shanghai, China

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)