Alira Health

Global healthcare consulting for life sciences

Senior Project Manager

Clinical Research OperationsUpdated on Nov 12

Full-timeBoston, MA, USA$140k - $150kRemote

About the Job

Requirements

A Bachelor of Science or Bachelor of Arts from an undergraduate program in life sciences or a related discipline, or equivalent experience.
At least 10 years of experience in the pharmaceutical, biotechnology, or contract research organization industry, including at least 5 years of clinical project management experience.
Strong attention to detail and the ability to be careful and thorough.
Strong organizational skills and the ability to multitask effectively in a fast-paced environment.
Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills.
Ability to problem-solve unstructured or ambiguous challenges.
Strong written and verbal command of English.
Proficiency with Microsoft Office Suite, particularly Word and Excel.
Permanent authorization to work in the United States.

Responsibilities

Manage clinical research studies in accordance with approved scope of work and budget, ICH Good Clinical Practice guidelines, FDA regulations, and established timelines.
Serve as study lead and primary contact for sponsors.
Manage clinical study functions, which may include investigational supply, IWRS/IXRS, data management, biostatistics, pharmacovigilance, and central laboratory.
Generate and present frequent study status updates and reports to sponsors.
Supervise and support Clinical team members, including Clinical Assistants, In-house Clinical Research Associates, and Clinical Research Associates.
Supervise and train Associate Clinical Project Managers and provide ongoing support and high-level guidance to Clinical Project Managers.
Create and review clinical study documents, including protocols, informed consent form templates, study budgets, site log and form templates, study manuals and plans, and site binders.
Drive and facilitate clinical teamwork and communications to ensure timely attainment of trial milestones.
Ensure the accuracy of reports and material work product.
Provide monthly billing information to the finance team.
Present at project meetings, including investigator meetings and new client meetings.
Update management accurately and regularly through frequent communication.
Identify issues and develop problem-solving strategies to ensure study timelines are met.
Manage subject accrual, retention, and compliance.
Assist with trial master file management and manage trial master file reviews as needed.
Prepare for and participate in third-party audits and FDA inspections.
Comply with and ensure team compliance with ICH Good Clinical Practice guidelines, FDA regulations, and company standard operating procedures.
Participate in internal, client/sponsor, scientific, and other meetings as required.
Perform additional duties as assigned.

Desired Qualifications

A life sciences or related discipline is preferred.

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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 withand 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
10years of experience in the pharmaceutical / biotechnology / CRO industrywith 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

About the Company

Alira Health

Global healthcare consulting for life sciences

Alira Health provides consulting and services to life sciences companies, helping pharmaceutical and biotechnology clients plan clinical strategies, conduct clinical research, advocate for patients, and select CDMOs. Its offerings include the enhanced Lupus Patient Registry (developed with FORWARD), which collects patient data to support research timelines and recruit participants for studies, plus market insights on biologics and advanced therapies. Services are delivered as advisory support, data assets, and registries to inform decision-making and accelerate development. The goal is to help clients optimize product development, improve trial recruitment, and make evidence-based, value-driven decisions in biologics and advanced therapies.

Company size: 501-1,000
Company stage: Debt Financing
Total funding: $233M
Headquarters: Paris, France
Founded: 1999

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