Clinical Project Manager

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

📋 Description

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

• Act as the primary lead and contact for sponsors throughout the study.

• Manage various clinical study functions, including investigational supplies, IWRS/IXRS, data management, biostatistics, pharmacovigilance, and central laboratory operations.

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

• Supervise and assist Clinical Assistants, In-house Clinical Research Associates, and Clinical Research Associates.

• Oversee and provide training for Associate Project Managers.

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

• Foster clinical teamwork and communication to achieve trial milestones.

• Ensure the accuracy of reports and deliverables.

• Provide monthly billing details to the finance team.

• Represent the organization at investigator meetings and new client presentations.

• Keep management informed through regular communication.

• Identify challenges and formulate problem-solving strategies to adhere to study timelines.

• Manage subject recruitment, retention, and compliance.

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

• Prepare for and take part 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 required meetings.

• Execute additional duties as assigned.

⛳️ Requirements

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

• 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 capabilities with the ability to manage multiple tasks and operate effectively in a fast-paced environment.

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

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

• Ability to tackle unstructured or ambiguous challenges with effective problem-solving skills.

• Proficient command of English, both written and spoken.

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

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

🏝️ Benefits

• Comprehensive health and wellness benefits.

• Opportunities for professional development and growth.

• Collaborative and inclusive work environment.

• Flexible working arrangements.