Project Manager

Role Overview

• 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.

Requirements

• BS/BA from an undergraduate program (life sciences or related discipline preferred) or equivalent experience
• 7 years of experience in the pharmaceutical / biotechnology / CRO industry with 5 years of management experience
• 2 years experience with Phase I IMP studies (FIH)
• 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

Tech Stack

• Google Cloud Platform

Benefits

• Professional development
• Global travel
• Flexible work programs