Clinical Project Manager

6 days ago

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Alira Health

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Nuclear medicine • Rare disease • Lupus • Myasthenia gravis • Robotics

501 - 1000

💰 $58M Venture Round on 2023-01

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.

Requirements

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