Project Manager

Alira Health

Verona

Hybrid

EUR 50,000 - 70,000

Full time

10 days ago
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Job summary

Alira Health in Verona (hybrid) is seeking a Project Manager to lead one or more clinical study protocols, ensuring timelines, budgets, and regulatory compliance are met while coordinating with sponsors and vendors.

You will act as study lead for sponsors, supervise clinical team members, and drive documentation, TMF reviews, audits, and investigator meetings.

A BS/BA in life sciences and 3 years in pharma/CRO, plus strong English, MS Office skills, and a collaborative mindset, are required.

Qualifications

  • BS/BA from undergraduate program in life sciences or related field; 3 years pharma/CRO industry experience with 1 year in management.
  • Experience leading clinical studies including budgeting, timelines, and regulatory compliance.
  • Strong communication, organizational, and cross-functional collaboration skills.

Responsibilities

  • Manages clinical research studies to ensure adherence to scope, budget, and timelines.
  • Serves as study lead and primary contact for sponsors.
  • Oversees investigational supply, IWRS/IXRS, data management, biostatistics, pharmacovigilance, and lab activities.
  • Generates status reports and presents to sponsors.
  • Supervises Clinical team members and trains Associate PMs.
  • Prepares study documents, budgets, and site materials.
  • Drives team communication to meet trial milestones.
  • Ensures accuracy of reports and TMF reviews as needed.
  • Supports third-party audits and FDA inspections.

Skills

Project management
Team leadership
Communication
Attention to detail
Multitasking
English proficiency

Education

BS in Biology
BS in Life Sciences
BS in Pharmacy

Tools

MS Office Suite
Excel
Word

Job description

Project ManagerSkip to main contentYou may choose to display a cookie banner on the external site. You must specify the message in the cookie banner and may add a link to a relevant policy. If you are unfamiliar with these requirements, please seek the advice of legal counsel.#Project Manager page is loaded## Project ManagerApplyremote type: Hybridlocations: Verona: Munich: Verona-Remote: Munich-Remotetime type: Full timeposted on: Posted 3 Days Agojob requisition id: JR000571**Are you being referred to one of our roles by a connection in Alira Health?** If so, please apply using the referral link emailed to you.Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.**Job Description Summary****Job Description**## ROLEThe 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.Salary range: € 50k - € 70k## KEY RESPONSABILITIES* 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.## DESIRED QUALIFICATION & EXPERIENCE* 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## TECHNICAL COMPETENCES & SOFT SKILLS* 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**Languages**English**Education**Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): Pharmacy**Contract Type**Regular
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