What are the responsibilities and job description for the Senior Project Manager position at Alira Health GmbH?
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
Job Description
ROLE
The Sr. Project Manager 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.
KEY RESPONSABILITIES
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.
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.
DESIRED QUALIFICATION & EXPERIENCE
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
TECHNICAL COMPETENCES & SOFT SKILLS
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 orientatio
Proficient with MS Office Suite, particularly Word and Excel
Permanent authorization to work in the U.S.
Languages
EnglishEducation
Bachelor of Science (BS): Biology, Bachelor of Science (BS): Biotechnology, Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): PharmacyContract Type
Regular