Clinical Project Manager

1 settimana fa

Lazio, Italia Alira Health Group A tempo pieno

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 FSP 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 RESPONSABILITIES FSP for potential clients 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 Contingency Workforce About Us 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 Med Tech clients with a full spectrum of services across their entire solutions lifecycle.

Why Work at Alira Health? 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.

Join Our Team 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.

Introduce yourself to our Recruiters Apply to one of our open jobs or send us your spontaneous application.

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