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GCDS Program Manager

Parexel International Corporation

Southeast, Remote, United States of America

PXL FSP is hiring a GCDS PROGRAM MANAGER (GCDS PM)!

Description of Role & Responsibilities

The Program Manager oversees the projects and or activities within Global Clinical Data Standards (GCDS) purview and the associated clinical information governance network in collaboration with the Director of Operations, GCDS. They monitor, track, and control outcomes to resolve issues, conflicts, dependencies, and critical path deliverables using a consistent project management methodology. Through teamwork and a data driven approach, they would work analytically and creatively to solve problems. Coordinates client standards governance network and facilitates client participating in and connecting with external standards related activities (e.g., CDISC, PhUSE, TransCelerate). Manages the definition, implementation, and maintenance of GCDS Standard Operating Procedures and supporting documentation to ensure compliance with worldwide regulatory and relevant internal client requirements.

Primary activities include, but are not limited to:

  • Ensure individual projects are completed on time, within budget, and in alignment with company goals (projects will have set timeframes).
  • Prepare and manage project materials, including a project plan, RACI, meeting materials (e.g., notes, decision log, action items, etc.), timeline, kick-offs, retrospective reviews.
  • Establish appropriate metrics to track and monitor progress and quality (as necessary).
  • Bring together team members.
  • Communication with and motivation of stakeholders.
  • Addressing pain points, risks, and maintaining quality control.
  • Prepare and maintain project status reports.
  • Ability to organize and run meetings efficiently.
  • Ability to show critical thinking and a “think-on-your-feet” mindset.
  • Lead/participate in cross-functional data governance reviews and projects.

Minimum FTE Years of Experience

  • Experience: 7+ years of work experience, which includes 5 years of program management experience.
  • Must have an innovative spirit, outstanding interpersonal skills, leadership and demonstrated proficiency in managing multiple projects.
  • Strong knowledge of the Drug Discovery Process, ICH and GCP guidelines
  • Proven ability to work collaboratively on interdisciplinary teams.
  • Strong interpersonal skills that demonstrate initiative and motivation.
  • Proven ability to solve complex problems.
  • Strong skills in project management
  • Ability to effectively organize and manage multiple assignments with challenging timelines.
  • Ability to mentor cross functional colleagues in data standards and metadata management practices.
  • Broad knowledge of and experience with clinical development & data management processes and regulatory requirements
  • Extensive program and/or project management experience managing and governing clinical information standards activities.
  • Awareness of industry standards (e.g., Controlled Terminologies, CDISC CDASH, SDTM, ADaM, and HL7) and submission deliverables (SDRG, ADRG, Define.xml).
  • Must have awareness of project management methodologies (e.g., Scrum, Agile, Waterfall) and tool.
  • Experience in defining, implementing, and managing process improvement projects and documentation.
  • A broad comprehensive knowledge of the clinical trial process including data management (data collection, processing, storage, and retrieval), requirements gathering, and worldwide regulatory data management and reporting requirements.
  • Exceptional verbal/written communication skills in a global environment; ability to communicate with technical and business stakeholders
  • Exceptional people and thought leadership skills; ability to think strategically, influence others and work collaboratively with cross-functional stakeholders.

Job posted: 2023-02-23

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