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Global Biometrics Delivery Lead

2+ years
Not Disclosed
10 Nov. 30, 2024
Job Description
Job Type: Full Time Education: CRO/BSc/MSc/PhD/BPharm/MPharm/PharmD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Role: Biometrics Delivery Lead (DL)

As a Biometrics Delivery Lead (DL) at Parexel, you will play a pivotal role in managing and delivering the Data Operations strategy for EMEA projects. This includes leadership over database programming, data integration, data management, statistical services, and medical writing. Reporting to the Global Biometrics Account Lead (AL), you will ensure the successful execution of deliverables by aligning timelines, quality, resourcing, and productivity across geographies. This role demands strong leadership, cross-functional collaboration, and technical expertise to ensure clinical trial success.


Key Responsibilities

Global Data Organization (GDO) Strategic Support

  • Lead and influence strategies to meet business objectives for Parexel and its clients.

  • Act as a primary point of contact for internal teams, clients, and third-party vendors to coordinate Data Operations deliverables.

  • Create and manage project timelines covering all GDO activities, ensuring dependencies across stakeholders are addressed.

  • Collaborate with study teams and Data Standards Associates to ensure adherence to data standards.

  • Serve as a technical expert, providing oversight and acting as an escalation point when required.

  • Stay informed of changes in relevant regulations and guidelines to ensure compliance.

Team Management and Leadership

  • Lead and motivate global project teams, establishing effective working relationships across functions.

  • Communicate project goals, deliverables, and metrics to ensure alignment and successful outcomes.

  • Manage team access to tools and resources, enabling efficient operations.

  • Provide leadership and direction to ensure smooth execution of tasks and project timelines.

  • Oversee project deliverables, ensuring adherence to SOPs, guidelines, and ICH-GCP standards.

Client and Stakeholder Engagement

  • Participate in proposal development, bid defense meetings, and scope discussions with Business Development and project teams.

  • Attend project kickoff meetings and other key sessions to align on goals and timelines.

  • Build trust and collaboration with clients and cross-functional leaders to drive project success.

Operational Excellence

  • Guide the team in reviewing protocols and ensuring readiness for Data Operations activities.

  • Ensure data integration and technology systems are set up for project needs.

  • Collaborate with Project Leaders and Managers to achieve seamless delivery of data services.


Ideal Candidate Profile

Qualifications and Experience

  • Several years of experience in CRO, Pharma, or Biotech industries, with demonstrated project management expertise.

  • Proven leadership experience in technical, data management, or statistical projects.

  • Bachelor’s degree in science, technology, or a related field.

  • Comprehensive understanding of ICH-GCP, SOPs, and international regulations.

  • Familiarity with data standards and their application in clinical trials.

Skills and Competencies

  • Leadership and Communication: Ability to motivate virtual, multicultural teams and foster collaboration.

  • Project Management: Strong skills in managing workloads, setting priorities, and achieving milestones.

  • Technical Acumen: Proficient understanding of cross-functional activities and data standards.

  • Client Focus: Excellent negotiation, diplomacy, and relationship-building skills.

  • Regulatory Knowledge: Expertise in compliance with SOPs, ICH-GCP, and other regulations.

  • Fluent in English with advanced presentation and public speaking abilities.


Why Join Parexel?

  • Innovative Projects: Work at the forefront of the clinical research industry.

  • Collaborative Culture: Be part of a supportive and inclusive environment that values your expertise.

  • Career Growth: Access professional development and advancement opportunities.

  • Flexibility: Enjoy work-life balance with remote-friendly and flexible working arrangements.

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