Project Manager

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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

ROLE

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.

KEY RESPONSABILITIES

• Manages clinical research studies to ensure studies are conducted in accordance with approved scope of workbudget, 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, IWRSIXRS, 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, Inhouse 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 logform 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 problemsolving 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 thirdparty audits and FDA inspections.

• Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company SOPs.

• Participates in internal, clientsponsor, scientific, and other meetings as required.

• Performs additional duties as assigned.

• DESIRED QUALIFICATION & EXPERIENCE

  • BSBA 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 detailoriented

    • Strong organizational skills and the ability to multitask and work effectively in a fastpaced environment

    • Strong analytical, negotiation, meeting management, crossfunctional team, and leadership skills

    • Selfstarter who thrives in a collaborative, yet less structured team environment

    • Ability to problemsolve 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