Ph3Overview /h3 pbAre 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. /b /p pJoin 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. /p h3Job Description Summary /h3 pProject manager with experience in FIH /p h3Job Description /h3 pbROLE /b /p pThe 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. /p h3Key Responsibilities /h3 ul liManages 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. /li liServes as study lead and primary contact for sponsors. /li liManages clinical study functions, which may include investigational supply, IWRS/IXRS, data management, biostatistics, pharmacovigilance, and central laboratory. /li liGenerates and presents frequent study status updates and reports to sponsor. /li liSupervises and provides support to the Clinical team, including Clinical Assistants, In-house Clinical Research Associates, and Clinical Research Associates. /li liSupervises and trains Associate PMs. /li liCreates and reviews clinical study documents, including protocols, ICF templates, study budgets, site log/form templates, study manuals and plans, site binders, etc. /li liDrives and facilitates clinical teamwork and communications to ensure timely attainment of trial milestones. /li liEnsures accuracy of reports and material work product. /li liProvides monthly billing information to finance team. /li liPresents at project meetings such as investigator meetings and new client meetings. /li liUpdates management accurately and regularly through frequent communication. /li liIdentifies issues and develops problem-solving strategies to ensure study timelines are met. /li liManages subject accrual, retention, and compliance. /li liAssists in TMF management and manages TMF reviews as needed. /li liPrepares for and participates in third-party audits and FDA inspections. /li liComplies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company SOPs. /li liParticipates in internal, client/sponsor, scientific, and other meetings as required. /li liPerforms additional duties as assigned. /li /ul h3Qualifications /h3 ul liBS/BA from an undergraduate program (life sciences or related discipline preferred) or equivalent experience /li li7 years of experience in the pharmaceutical / biotechnology / CRO industry with 5 year of management experience /li li2 years experience with Phase I IMP studies (FIH) /li /ul h3Technical Competences Soft Skills /h3 ul liProven ability to be careful, thorough, and detail-oriented /li liStrong organizational skills and the ability to multi-task and work effectively in a fast-paced environment /li liStrong analytical, negotiation, meeting management, cross-functional team, and leadership skills /li liSelf-starter who thrives in a collaborative, yet less structured team environment /li liAbility to problem-solve unstructured or ambiguous challenges /li liStrong command of English, both written and verbal /li liExcellent communication and interpersonal skills with customer service orientation /li liProficient with MS Office Suite, particularly Word and Excel /li /ul h3Languages /h3 pEnglish /p h3Education /h3 ul liBachelor of Science (BS): Biology /li liBachelor of Science (BS): Life Sciences /li liBachelor of Science (BS): Pharmacy /li /ul h3Contract Type /h3 pFixed Term (Fixed Term) /p /p #J-18808-Ljbffr