Project Manager

This is a fully remote position, open to applicants in Italy.

📋 Description

• Oversees clinical research studies to guarantee compliance with the approved scope of work/budget, ICH GCP guidelines, and FDA regulations while adhering to established timelines.

• Acts as the study lead and primary liaison for sponsors.

• Manages clinical study operations, which may encompass investigational supply, IWRS/IXRS, data management, biostatistics, pharmacovigilance, and central laboratory functions.

• Produces and shares regular study status updates and reports with sponsors.

• Supervises and supports the Clinical team, which includes Clinical Assistants, In-house Clinical Research Associates, and Clinical Research Associates.

• Oversees and trains Associate Project Managers (PMs).

• Develops and reviews clinical study documents, such as protocols, ICF templates, study budgets, site log/form templates, study manuals and plans, and site binders.

• Facilitates clinical teamwork and communication to ensure timely achievement of trial milestones.

• Ensures the accuracy of reports and the quality of work products.

• Provides monthly billing details to the finance team.

• Delivers presentations at project meetings, including investigator meetings and new client sessions.

• Keeps management informed through regular and accurate communication.

• Identifies challenges and formulates problem-solving strategies to ensure study timelines are adhered to.

• Manages subject accrual, retention, and compliance effectively.

• Assists in managing the Trial Master File (TMF) and conducts TMF reviews as necessary.

• Prepares for and engages in third-party audits and FDA inspections.

• Ensures compliance with ICH GCP guidelines, FDA regulations, and company Standard Operating Procedures (SOPs).

• Participates in internal, client/sponsor, scientific, and other required meetings.

• Performs additional responsibilities as assigned.

⛳️ Requirements

• Bachelor's degree (BS/BA) from an undergraduate program, preferably in life sciences or a related field.

• Minimum of 3 years of experience in the pharmaceutical, biotechnology, or CRO industry, including at least 1 year in a management role.

• Demonstrated ability to be meticulous, thorough, and detail-oriented.

• Strong organizational abilities with the capacity to multi-task and function effectively in a fast-paced environment.

• Excellent analytical, negotiation, meeting management, cross-functional teamwork, and leadership skills.

• Self-motivated individual who excels in a collaborative yet less structured team setting.

• Capable of addressing unstructured or ambiguous challenges with effective problem-solving skills.

• Proficient command of the English language, both written and verbal.

• Outstanding communication and interpersonal skills with a focus on customer service.

• Proficient in MS Office Suite, particularly Word and Excel.

🏝️ Benefits

• Opportunities for professional development.

• Global travel possibilities.

• Flexible work programs.