Sr. Project Manager

Sr. Project Manager The Sr. Project Manager is an important member of the Alira Health Clinical team, ensuring efficient implementation of study protocols, close collaboration with clinical team members, and direct communication with study sponsors and vendors. Key Responsibilities Manages clinical research studies to ensure studies are conducted in accordance with approved scope of work, budget, ICH GCP guidelines, FDA regulations, and established timelines. Serves as study lead and primary contact for sponsors. Manages clinical study functions, including investigational supply, IWRS/IXRS, data management, biostatistics, pharmacovigilance, and central laboratory. Generates and presents frequent study status updates and reports to sponsor. Supervises and supports the Clinical team, including Clinical Assistants, In‑house Clinical Research Associates, and Clinical Research Associates. Supervises and trains Associate CPMs and provides ongoing support and guidance to CPMs. Creates and reviews clinical study documents such as protocols, ICF templates, study budgets, site log/form templates, study manuals and plans, and site binders. Drives and facilitates clinical teamwork and communication to ensure timely attainment of trial milestones. Ensures accuracy of reports and material work product. Provides monthly billing information to finance team. Participates in 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 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 Qualifications & Experience BS/BA from an undergraduate program (life sciences or related discipline preferred) or equivalent experience. 10 years of experience in the pharmaceutical, biotechnology, or CRO industry with at least 5 years of clinical project management experience. Proven ability to be careful, thorough, and detail‑oriented. Strong organizational skills and the ability to multi‑task 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. Permanent authorization to work in the U.S. Education options: Bachelor of Science (BS) in Biology, Biotechnology, Life Sciences, or Pharmacy. #J-18808-Ljbffr