Biometrics Delivery Lead

2 months ago

Pretoria, South Africa Parexel Full time

**Picture Yourself At Parexel**:
The Biometrics Delivery Lead (DL), reporting into the Global Biometrics Account Lead (AL) has overall accountability for the execution of the Data Operations strategy and the Data Operations technology set up for the EMEA project. The DL provides overall leadership/management for database programming, data integration, data management, statistical services and medical writing on a project/program. General areas of responsibility include oversight of the Global Data Operations team members and their activities across all geographies, liaising with the AL, 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. The DL may take on some AL responsibilities for projects involving a small number of services, where no account lead is assigned.

**What You'll Do At Parexel**:
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
- Work with study teams and Data Standards Associates to ensure enforce the use of data standards as applicable
- 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
- 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
- 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
- Several years’ experience within CRO/Pharma/Biotech
- Proven record of leading a project team in a technical/programming, data management or statistical environment with mínimal supervision
- Proficient understanding of cross-functional activities
- Bachelor’s degree in a science or industry related discipline
- Fluent English
- Ability to successfully manage a full workload across multiple and varied studies with enthusiasm and prioritize workload with attention to detail
- Knowledge of SOPs/guidelines, ICH-GCP and other applicable local and international regulations
- Understanding of the needs and use of data standards in the clinical trial environment
- Project management skills such as improving presentation skills, public speaking foundations, speaking confidently and effectively, boosting your confidence, public speaking and performance, delivery tips for speaking in public, Centered communication: get better

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