Senior Project Manager

Alira Health; Boston (MA); On-site; USD 140,000 - 150,000; Full time

Job summary

Alira Health is seeking a Senior Project Manager to lead clinical study implementation within the Clinical team. You will work closely with sponsors and vendors, ensuring adherence to timelines, scope, and budget while complying with ICH GCP and FDA requirements.

The role requires a strong background in clinical project management, leadership, and cross-functional collaboration across data management, statistics, pharmacovigilance, and labs. Excellent communication in English is essential.

Qualifications

• Careful, thorough, and detail-oriented approach.
• Strong organizational and multitasking abilities in fast-paced environments.
• Excellent analytical, negotiation, and leadership skills.

Responsibilities

• Manages clinical research studies per scope, budget, ICH GCP, and FDA timelines.
• Serves as study lead and primary contact for sponsors.
• Oversees study functions including data management, biostatistics, pharmacovigilance, and central lab.
• Generates and presents regular study status updates to sponsors.
• Supervises and guides Clinical team members and CPMs.

Skills

Detail-oriented

Project management

Leadership

Cross-functional teamwork

English proficiency

Education

BS/BA in Life Sciences or related

Equivalent experience

Tools

MS Office

Word

Excel

Job description

Are you being referred to one of our roles by a connection in Alira Health?

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.

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

English

Education

Bachelor of Science (BS): Biology, Bachelor of Science (BS): Biotechnology, Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): Pharmacy

Contract Type

Regular

Salary Range

The final offer will be determined within the applicable location-specific range and will depend on the candidate’s confirmed work location, relevant experience, skills, qualifications, internal equity, and role scope.

$140,000 - $150,000