Senior Project Manager

Alira Health Boston, LLC; Boston (MA); Hybrid; USD 140,000 - 150,000; Full time

Job summary

Alira Health Boston, LLC is seeking a Sr. Project Manager to join our Clinical team. The SCPM will oversee the efficient execution of study protocols, coordinate with sponsors and vendors, and ensure adherence to ICH GCP and FDA regulations.

You will lead cross-functional study activities, manage timelines, budgets, TMF, and participate in audits. The role requires a BS/BA in life sciences and at least 5 years of clinical project management within pharma/biotech/CRO.

Qualifications

• BS/BA in life sciences or related discipline.
• 10 years of experience in the pharmaceutical/biotechnology/CRO industry with at least 5 years of clinical project management experience.
• Strong organizational, analytical, negotiation, meeting management, cross-functional team, and leadership skills.

Responsibilities

• 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 trains Associate CPMs and provides ongoing support and high-level guidance to CPMs.

Skills

Attention to detail

Organizational skills

Analytical skills

Leadership

Communication

Problem solving

English proficiency

Cross-functional collaboration

Education

BS/BA in Life Sciences or related discipline

Tools

MS Office

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.

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 RESPONSIBILITIES

• 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.
• Present 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

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

Alira Health is a global advisory firm providing consulting and research and clinical development services whose mission is to humanize healthcare and life sciences, in partnership with patients, through innovative technologies and expert guidance. From development to medical care, we complement the expertise of our Pharma, Biotech, and MedTech clients with a full spectrum of services across their entire solutions lifecycle. With offices around the world, Alira Health provides a vibrant and creative environment with benefits that include professional development, global travel, flexible work programs and more. We welcome your passion and drive, talent and entrepreneurial spirit, sense of service and teamwork. We are an integrated team of over 800 scientists, strategists, economists, clinicians, and biostatisticians representing over 30 nationalities. This broad global perspective and cultural richness has a direct impact on providing innovative solutions for our clients that lead to higher standards of care and an improved patient experience.