Senior Project Manager

Alira Health

. Manage clinical research studies according to approved scope of work/budget, ICH GCP guidelines, FDA regulations, and established timelines .

Posted 10/14/2026full-timeRemote • Massachusetts • United StatesSenior💰 $140,000 - $150,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in clinical project management within the pharmaceutical and biotechnology sectors, ensuring compliance with ICH GCP guidelines and FDA regulations. Proficient in managing clinical study functions, generating reports, and leading cross-functional teams to achieve study milestones.

Highest-signal resume keywords

Clinical Project ManagementICH GCP ComplianceFDA RegulationsData ManagementLeadership Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study ManagementInvestigational Supply ManagementBiostatisticsPharmacovigilanceClinical Document CreationTMF ManagementBudget ManagementStudy Protocol DevelopmentSubject Accrual ManagementProblem-Solving Strategies

Soft Skills

Strong Organizational SkillsExcellent Communication SkillsInterpersonal SkillsNegotiation SkillsAnalytical Skills

Tools & Technologies

MS Office SuiteIWRS/IXRS

Industry Keywords

Pharmaceutical IndustryBiotechnologyCROClinical ResearchLife Sciences

About the role

Key responsibilities & impact

Manage clinical research studies according to approved scope of work/budget, ICH GCP guidelines, FDA regulations, and established timelines
Serve as study lead and primary contact for sponsors
Manage clinical study functions including investigational supply, IWRS/IXRS, data management, biostatistics, pharmacovigilance, and central laboratory
Generate and present study status updates and reports to sponsors
Supervise and support Clinical Assistants, In-house Clinical Research Associates, and Clinical Research Associates
Supervise and train Associate CPMs and provide guidance to CPMs
Create and review clinical study documents, protocols, ICF templates, budgets, site logs/forms, study manuals and plans, and site binders
Facilitate clinical teamwork and communications to achieve trial milestones
Ensure accuracy of reports and work products
Provide monthly billing information to the finance team
Present at investigator meetings and new client meetings
Update management through frequent communication
Identify issues and develop problem-solving strategies to meet study timelines
Manage subject accrual, retention, and compliance
Assist with TMF management and manage TMF reviews as needed
Prepare for and participate in third-party audits and FDA inspections
Ensure compliance with ICH GCP guidelines, FDA regulations, and company SOPs
Participate in internal, client/sponsor, scientific, and other meetings
Perform additional duties as assigned

Requirements

What you’ll need

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 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.
Bachelor of Science in Biology, Biotechnology, Life Sciences, or Pharmacy