Associate Global Biometrics Delivery Lead

3 days ago

Bloemfontein, Orange Free State, South Africa Parexel Full time

When our values align, there's no limit to what we can achieve.

This role can be flexibly based in select EMEA locations.

Picture Yourself At Parexel :

The Associate Global Biometrics Delivery Lead (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 Global Biometrics Delivery Lead provides overall leadership and management for database programming, data integration, data management, and statistical services on a project or program.

The Associate Global Biometrics Delivery Lead takes on the Biometrics Delivery Lead responsibilities for the assigned selected tasks while the overall responsibility for the management of the Data Operations activities remains with the Biometrics Delivery Lead or Account Lead. The Associate Global Biometrics Delivery Lead may work in a Biometrics Delivery Leader role (with support from the Line Manager) for reduced-scope projects.

What You'll Do At Parexel :

  1. Effectively communicate with internal and external customers as well as third party vendors.
  2. Participate in cross functional meetings and support initiatives to ensure the delivery of milestones and timelines for clinical trials.
  3. Ensure all systems, both technical and non-technical, are set up.
  4. 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.
  5. Work with study teams and Data Standards Associates to ensure the enforcement of data standards as applicable.
  6. Provide technical knowledge and oversight and serve as an escalation point where appropriate.
  7. Remain informed about developments in relevant regulations and guidelines.
  8. Support Account Lead / Delivery Lead with Bid Defense meeting preparations as directed.
  9. Understand scope of contract and any Master Service Agreement in place for the client.
  10. Ensure the operational team reviews the draft protocol from a Data Operations perspective.
  11. Attend project kick off meetings and other project related meetings.
  12. Identify and request staff necessary for the project team.
  13. Accountable for ensuring all team members have access to tools and documents as required.
  14. Ensure information entered in internal management systems is accurate and updated on a regular basis.
  15. Establish efficient and effective working relationships with other functional leaders and experts.
  16. With assistance, provide leadership and direction to the project team members.
  17. Communicate project metric targets to the project team members and guide the team towards achieving them.
  18. Ensure the project is progressing according to quality standards, SOPs, ICH, and/or other guidelines to fulfill regulations.
  19. Perform early risk mitigation, identifying areas of potential problems and providing input into the Risk Management Plan.
  20. Monitor KRIs, propose DL-led risk signal evaluations, and perform associated milestone document TMF reviews.
  21. Track resources and actual time spent on each project task for all team members to evaluate project progress and productivity.
  22. Record and measure progress of the study against project plans to mitigate risk and ensure updates are made accordingly.
  23. Implement and instigate process improvements within the project.
  24. Work with functional experts to track scope of ongoing work to identify changes in scope in a timely manner.
  25. Hold internal team meetings on a regular basis, monitoring the progress of each individual project task, and assessing the overall status of the project.
  26. May participate in client, investigator, and team meetings with support from the Delivery Lead or Account Lead.
  27. Prepare, participate in, and follow up on audits, inspections, and QIs.
  28. Collaborate with Data Operations team, the Clinical Operations Leader, and other functions on project close out activities.
  29. Ensure all administrative close out procedures are completed on the project.
  30. Ensure project is archived and appropriate documentation returned to the client.
  31. Participate in end of study meetings and collate lessons learned information and feedback relevant information into the functions.

Role requirements :

  1. Several years' experience in clinical research within CRO, Pharma, or Biotech.
  2. Experience of leading a project team in a technical, programming, data management, or statistical environment with supervision.
  3. Good understanding of cross functional activities.
  4. Demonstrated application of project management concepts.
  5. Bachelor's degree in a science or industry related discipline.
  6. Ability to successfully manage a full workload across multiple and varied studies with enthusiasm and prioritize workload with attention to detail.
  7. Knowledge of SOPs, guidelines, ICH-GCP, and other applicable local and international regulations.
  8. Understanding of the needs and use of data standards in the clinical trial environment.
  9. Ability to work effectively with and motivate virtual teams within different cultural environments.
  10. Emerging 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 results from your conversations, critical thinking, and building trust.
  11. Proficient negotiation and diplomacy skills.

Opportunity to work on innovative projects at the forefront of the industry.

Collaborative and inclusive work environment that values your expertise.

Professional advancement and development opportunities.

Work life balance and flexible working hours.

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