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Job Description Summary
Project manager with experience in FIHJob 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.
BS/BA from an undergraduate program (life sciences or related discipline preferred) or equivalent experience
7 years of experience in the pharmaceutical / biotechnology / CRO industry with 5 year of management experience
2 years experience with Phase I IMP studies (FIH)
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
EnglishEducation
Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): PharmacyContract Type
Fixed Term (Fixed Term)
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