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Project Manager, Global Statistical and Data Sciences (GSD)

UNLIMITED HOLIDAYS - EXTRA HOLIDAYS - EXTRA PARENTAL LEAVE - LONG REMOTE PERIOD ALLOWED
Remote: 
Full Remote
Contract: 
Experience: 
Mid-level (2-5 years)
Work from: 

Offer summary

Qualifications:

Experience in Biometrics project management, Expertise in clinical trials analysis, Strong understanding of drug development, Knowledge of regulatory compliance standards, Ability to manage timelines and resources.

Key responsabilities:

  • Manage analysis and reporting activities
  • Work with multiple product/program levels
  • Drive cross-functional communication
  • Develop and implement project plans
  • Track progress and manage operational risks
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201 - 500 Employees
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Job description

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SOW Pre ID Title: Project Manager, Global Statistical and Data Sciences (GSD) Department: Business Strategy and Operations Supervisor's Title: Director, Business Strategy and Operations Location: NJ-Remote

Position Summary:

The GSD Project Manager is an experienced Biometrics project manager who is responsible for managing the analysis and reporting activities for drug development projects sponsored by Client Research and Development (R&D). The Project Manager works closely with the Statistical, Clinical Programming, and Medical Writing project Leads to align on key program work, priorities, and staffing for their teams. This role is accountable for managing the timelines and resources of analysis and reporting activities of assigned Phase I to Phase IV clinical trials, Health Authority submissions or responses, and annual reporting. The Project Manager ensures that all GSD cross-functional deliverables of assigned projects are achieved on or ahead of schedule, within budget targets, and with quality that meets or exceeds business needs. As a project manager, this role interacts with many stakeholders across the R&D organization such as Regulatory, Clinical Development, Project Leadership, and Operations to align on timelines for deliverables and provides key input into planning and risk management for upcoming milestones.

Essential Duties & Responsibilities:

  • Primarily work on the multiple product/program level
  • For assigned projects:
    • Provide planning and execution of deliverables involving Clinical Statistics, Clinical Programming and Medical Writing activities
    • Drive cross-functional communication and engagement with internal and external stakeholders
    • Develop, gain alignment, and implement project plans (e.g. activities, deliverables, timelines, resources, work assignments) that are aligned with the R&D approved objectives and timelines with input from GSD Functional Lead(s)
    • Track progress against scheduled milestones and activities, help GSD Project Management head collect metrics data, and proactively identify operational risks/issues and provide remediation plans
    • Ensure GSD project team is compliant with regulatory requirements and guidance, corporate and departmental procedures, and standards. Identify potential compliance issues within GSD project team (e.g. knowledge gaps) and partners with functional management to remediate

Required profile

Experience

Level of experience: Mid-level (2-5 years)
Spoken language(s):
Check out the description to know which languages are mandatory.

Soft Skills

  • Verbal Communication Skills
  • Analytical Thinking
  • Timelines

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