Clinical Project Manager

Alira Health; United States; Remote; USD 115.000 - 145.000; Vollzeit

Zusammenfassung

Alira Health in the United States is seeking an experienced Project Manager to guide multiple study protocols from initiation to closeout. You will work with the clinical team and liaise with sponsors to ensure timelines, budgets, and regulatory requirements are met.

The role requires strong leadership, attention to detail, and excellent communication. You will supervise junior staff, manage document workflows, and present updates at sponsor meetings, audits, and internal reviews.

Qualifikationen

• BS/BA in life sciences or related discipline or equivalent experience.
• 3 years of experience in pharmaceutical/biotech/CRO with 1 year of management experience.
• Strong command of English, written and verbal.

Aufgaben

• Manage clinical studies to ensure adherence to scope, budget, ICH GCP, and FDA regulations within timelines.
• Serve as study lead and primary contact for sponsors.
• Oversee clinical study functions including data management, biostatistics, pharmacovigilance, and central laboratory.
• Generate and present regular study status updates and sponsor reports.
• Supervise and train Associate PMs and Clinical team members.

Kenntnisse

Attention to detail

Organizational skills

Analytical

Leadership

Communication

Ausbildung

BS in Biology

BS in Life Sciences

BS in Pharmacy

Tools

MS Office Suite

Jobbeschreibung

Job Description Summary

Job Description

ROLE

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.

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 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.

DESIRED QUALIFICATION & EXPERIENCE

• 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

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 orientation

• Proficient with MS Office Suite, particularly Word and Excel

Languages

English

Education

Bachelor of Science (BS): Biology, 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.

115,000 - 145,000