Project Manager

Key Responsabilities

• 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.
• 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.
• Aids 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

Compensation

USD $115,000 - 145,000