Senior Global Biometrics Delivery Lead/Project Manager

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

The role is remote based from anywhere in the US or Canada

The Senior Biometrics Delivery Lead (DL), has overall accountability for the execution of the Data Operations strategy and the Data Operations technology set up for projects.  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, liaising with the account lead, 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.

Main responsibilities:

Global Data Organization (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 (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

• 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

• Remain informed about developments in relevant regulations and guidelines.

• With assistance provide input to proposals and attend Bid Defense meetings as required

• Ensure the operational team reviews the draft protocol from a Data Operations perspective

• Review and collate information required for the project tools, project plan, TMF, resourcing, etc. in collaboration with the PL/PM.

• 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

Ideal candidate will possess:

• Demonstrated application of project management concepts

• Proven record of leading a project team in a technical/programming, data ma