Boston, Massachusetts, United States · Remote OK
$115k–$145k/yr
🔗Are you being referred to one of our roles by a connection in Alira Health? If so, please apply using the referral link emailed to you. Join our global team dedicated to innovation and initiative, where physical walls …
Skills: Clinical Research Management, ICH GCP Guidelines, FDA Regulations, Project Management, Budget Management
Los Angeles, California, United States · Remote OK
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Boston, Massachusetts, United States · Hybrid
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Boston, Massachusetts, United States · Remote OK
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Boston, Massachusetts, United States · On-site
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Boston, Massachusetts, United States · Hybrid
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Boston, Massachusetts, United States · On-site
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Boston, Massachusetts, United States · Hybrid
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By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice an…
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Boston, Massachusetts, United States · On-site
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Boston, Massachusetts, United States · Hybrid
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Chicago, Illinois, United States · Hybrid
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Boston, Massachusetts, United States · Hybrid
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Boston, Massachusetts, United States · On-site
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Skills: Business Operations, Program Management, Supply Chain Management, Project Planning, Data Analysis
San Francisco, California, United States · Hybrid
$185k–$270k/yr
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Boston, Massachusetts, United States · Hybrid
$154k–$243k/yr
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice an…
Skills: Strategic Planning, Drug Discovery, Analytical Frameworks, Management Consulting, Executive Communication
Boston, Massachusetts, United States · Hybrid
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As a leading financial services and healthcare technology company based on revenue, SS&C is headquartered in Windsor, Connecticut, and has 27,000+ employees in 35 countries. Some 20,000 financial services and healthcare …
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Boston, Massachusetts, United States · Hybrid
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Boston, Massachusetts, United States · On-site
$67k–$87k/yr
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Skills: US GAAP, Account Reconciliation, Journal Entries, Fixed Asset Accounting, Financial Reporting
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The Project Manager oversees the implementation of clinical study protocols, ensuring compliance with ICH GCP and FDA regulations. They serve as the primary contact for sponsors and manage cross-functional clinical team functions to meet trial milestones.
Requires a Bachelor's degree in life sciences or a related field with at least 3 years of experience in the pharmaceutical, biotech, or CRO industry. Candidates must have at least 1 year of management experience and strong organizational and communication skills.
🔗Are you being referred to one of our roles by a connection in Alira Health? If so, please apply using the referral link emailed to you.
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.
The Project Manager (PM) is an important member of the Alira Health Clinical team. The PM ensures the efficient implementation of one or more study protocols, works closely with all Clinical team members, and communicates directly with study sponsors and vendors.
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 PMs.
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.
BS/BA from an undergraduate program (life sciences or related discipline preferred) or equivalent experience
3 years of experience in the pharmaceutical / biotechnology / CRO industry with 1 year of management experience
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 orientation
Proficient with MS Office Suite, particularly Word and Excel
Compensation: USD $115,000 - 145,000
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.
Trusted Advisor and CRO for Life Sciences Companies Globally
Alira Health is a global healthcare consultancy redefining evidence generation through patient partnerships. By uniting strategic consulting, CRO services, and technology, the company supports life sciences organizations in accelerating development, improving access, and delivering measurable outcomes across the product lifecycle.
Offices: 1 Grant St, Framingham, Massachusetts 01702, US · Anna-Sigmund Strasse 1-3, Munich, Germany 82061, DE · Carrer d'aragó, 326, Principal Floor, Barcelona, Catalonia 08009, ES · Via Germania, 2, Verona, Veneto 37136, IT · Hochbergerstrasse 60f, Basel, BS 4057, CH
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