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Project Manager @Alira Health GmbH

[Hiring] Project Manager @Alira Health GmbH

Mar 31, 2025 - Alira Health GmbH is hiring a remote Project Manager. 💸 Salary: unspecified. 📍Location: Germany.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more.

Role Description

The Project Manager (PM) is an important member of the Alira Health Clinical team. The PM ensures the efficient implementation of one or more study protocols, works closely with all Clinical team members, and communicates directly with study sponsors and vendors.

  • Manages clinical research studies to ensure studies are conducted in accordance with approved scope of work/budget, ICH GCP guidelines, and FDA regulations and within established timelines.
  • Serves as study lead and primary contact for sponsors.
  • Manages clinical study functions, which may include investigational supply, IWRS/IXRS, data management, biostatistics, pharmacovigilance, and central laboratory.
  • Generates and presents frequent study status updates and reports to sponsor.
  • Supervises and provides support to the Clinical team, including Clinical Assistants, In-house Clinical Research Associates, and Clinical Research Associates.
  • Supervises and trains Associate PMs.
  • Creates and reviews clinical study documents, including protocols, ICF templates, study budgets, site log/form templates, study manuals and plans, site binders, etc.
  • Drives and facilitates clinical teamwork and communications to ensure timely attainment of trial milestones.
  • Ensures accuracy of reports and material work product.
  • Provides monthly billing information to finance team.
  • Presents at project meetings such as investigator meetings and new client meetings.
  • Updates management accurately and regularly through frequent communication.
  • Identifies issues and develops problem-solving strategies to ensure study timelines are met.
  • Manages subject accrual, retention, and compliance.
  • Assists in TMF management and manages TMF reviews as needed.
  • Prepares for and participates in third-party audits and FDA inspections.
  • Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company SOPs.
  • Participates in internal, client/sponsor, scientific, and other meetings as required.
  • Performs additional duties as assigned.

Qualifications

  • BS/BA from an undergraduate program (life sciences or related discipline preferred) or equivalent experience.
  • 3 years of experience in the pharmaceutical / biotechnology / CRO industry with 1 year of management experience.

Requirements

  • Proven ability to be careful, thorough, and detail-oriented.
  • Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment.
  • Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills.
  • Self-starter who thrives in a collaborative, yet less structured team environment.
  • Ability to problem-solve unstructured or ambiguous challenges.
  • Strong command of English, both written and verbal.
  • Excellent communication and interpersonal skills with customer service orientation.
  • Proficient with MS Office Suite, particularly Word and Excel.

Benefits

  • Professional development.
  • Global travel.
  • Flexible work programs.

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Before You Apply
📍 Be aware of the location restriction for this remote position: Germany
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Project Manager @Alira Health GmbH
Project Management
Salary 💸 unspecified
Remote Location
Germany
Job Type full-time
Posted Mar 31, 2025
Apply for this position Unlock 54,857 Remote Jobs
📍 Be aware of the location restriction for this remote position: Germany
Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.
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