Project Manager

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

📋 Description

• Oversee clinical research studies in line with the approved scope of work/budget, ICH GCP guidelines, FDA regulations, and designated timelines.

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

• Manage clinical study operations, including investigational supply, IWRS/IXRS, data management, biostatistics, pharmacovigilance, and central laboratory activities.

• Create and deliver study status updates and reports to sponsors.

• Supervise and support members of the Clinical team, including Clinical Assistants, In-house Clinical Research Associates, and Clinical Research Associates.

• Oversee and mentor Associate Project Managers.

• Develop and review clinical study documents, protocols, ICF templates, study budgets, site logs/forms, study manuals and plans, and site binders.

• Foster teamwork and communication within the clinical team to meet trial milestones.

• Ensure the accuracy of reports and deliverables.

• Provide monthly billing details to the finance department.

• Present at investigator and new client meetings.

• Keep management informed through regular communication.

• Identify challenges and formulate strategies to resolve issues and adhere to study timelines.

• Manage subject recruitment, retention, and compliance.

• Assist in TMF management and conduct TMF reviews as necessary.

• Prepare for and engage in third-party audits and FDA inspections.

• Ensure adherence to ICH GCP guidelines, FDA regulations, and company SOPs.

• Participate in internal, client/sponsor, scientific, and other relevant meetings.

• Carry out additional responsibilities as assigned.

⛳️ Requirements

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

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

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

• Strong organizational skills with the capability to manage multiple tasks and work efficiently in a fast-paced environment.

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

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

• Ability to tackle unstructured or ambiguous challenges effectively.

• 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, especially Word and Excel.

🏝️ Benefits

• Comprehensive health, dental, and vision insurance.

• Competitive salary and performance-based bonuses.

• Opportunities for professional development and career advancement.

• Flexible working arrangements.

• Supportive and inclusive work environment.