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
At Alira Health, our mission is to enable healthcare transformation. Our team collaborates fully to understand every aspect of each client's organization from concept ideation to commercial realization, from innovation to implementation. We support our clients with a full spectrum of patient-centric data and tech-enabled services including Transaction Advisory, Management Consulting, Real-World Evidence, Advanced Analytics, Patient Engagement, Product Development, Regulatory, Clinical, and Market Access.
Our clients are global, and so are we. Our local presence and global collaboration allow us to deliver actionable business insights and an unmatched continuum of support across the full corporate and product lifecycle. We operate across thirteen offices located in Boston and San Francisco in the US; Barcelona, Basel, Bologna, Geneva, Milan, Munich, Paris, and Verona in Europe; Cambridge, United Kingdom; Sydney, Australia; and Toronto, Canada.
Job Description
The Sr. Clinical Project Manager (SCPM) is an important member of the Alira Health Clinical team. The SCPM ensures the efficient implementation of study protocols, works closely with all Clinical team members, and communicates directly with study sponsors and vendors.
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 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 CPMs and provides ongoing support and high-level guidance to CPMs
•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
Alira Health - Sr. Clinical Project Manager Page 2 of 2
Version: March 2023
•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
PREPARATION, KNOWLEDGE, SKILLS & ABILITIES
•BS/BA from an undergraduate program (life sciences or related discipline preferred) or equivalent experience
•10 years of experience in the pharmaceutical / biotechnology / 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 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.
Languages
Education
Contract Type
Regular