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 THE SR. PROJECT MANAGER ROLE The Sr. Project Manager (Sr. PM) serves as a project lead to ensure the efficient implementation of study protocols. The Sr. PM works closely with all Clinical Operations and cross-functional team members and communicates directly with study sponsors and vendors. The Sr. PM serves as an important resource for less experienced team members and assists with team training, process improvements, and other initiatives. Job Description ESSENTIAL JOB FUNCTIONS 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 project lead and primary contact for sponsors. Oversees all 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 sponsors. Supervises and provides support to the Clinical Operations team, including Clinical Assistants, In-house Clinical Research Associates, and Clinical Research Associates. Assists with training of Associate Project Managers (APMs) and provides ongoing support and high-level guidance to PMs. Creates and reviews clinical study documents, including protocols, ICF templates, site study budgets, site log/form templates, study manuals and plans, etc. Drives and facilitates teamwork and communication to ensure timely attainment of trial milestones and delivery of quality work product. Ensures accuracy of reports and material work product. Provides monthly billing and revenue 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. Coordinates/assists with TMF management and 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. Travel for participation in client meetings or for other in-person activities as required (< 20%), including the ability to travel internationally. Performs additional duties as assigned. PREPARATION, KNOWLEDGE, SKILLS & ABILITIES BS/BA from an undergraduate program (life sciences or related discipline preferred) or equivalent combination of experience and training 10 years of experience in the pharmaceutical / biotechnology / CRO industry with at least 5 years of direct clinical project management experience and experience in all trial aspects (i.e., start-up through closeout) 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 Permanent authorization to work in the U.S. Valid US passport or equivalent document for international travel WORKING CONDITIONS/PHYSICAL DEMANDS Normal office working conditions including frequent sitting, standing, bending, twisting and computer monitor use. Occasional lifting up to 30 lbs. The above statements are intended to describe the general nature and level of work being performed by people assigned to do this job. The above is not intended to be an exhaustive list of all responsibilities and duties required. External and internal applicants, as well as position incumbents who become disabled as defined under the Americans with Disabilities Act must be able to perform the essential job functions (as listed) either unaided or with the assistance of a reasonable accommodation to be determined by management on a case-by-case basis. Alira Health is an equal opportunity employer. Languages Education Contract Type Regular Alira Health is a global advisory firm providing consulting and research and clinical development services whose mission is to humanize healthcare and life sciences, in partnership with patients, through innovative technologies and expert guidance. From development to medical care, we complement the expertise of our Pharma, Biotech, and MedTech clients with a full spectrum of services across their entire solutions lifecycle. With offices around the world, Alira Health provides a vibrant and creative environment with benefits that include professional development, global travel, flexible work programs and more. We welcome your passion and drive, talent and entrepreneurial spirit, sense of service and teamwork. We are an integrated team of over 800 scientists, strategists, economists, clinicians, and biostatisticians representing over 30 nationalities. This broad global perspective and cultural richness has a direct impact on providing innovative solutions for our clients that lead to higher standards of care and an improved patient experience. Learn more Introduce yourself to our Recruiters! Apply to one of our open jobs or send us your spontaneous application.
