Senior Project Manager

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

📋 Description

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

• Act as the study lead and the main point of contact for sponsors.

• Administer clinical study operations, which include investigational supply, IWRS/IXRS, data management, biostatistics, pharmacovigilance, and central laboratory coordination.

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

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

• Oversee and train Associate CPMs while providing guidance to CPMs.

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

• Promote teamwork and communication within clinical teams to reach trial milestones.

• Ensure the accuracy of reports and deliverables.

• Provide monthly billing details to the finance team.

• Present at investigator meetings and meetings with new clients.

• Keep management updated through regular communication.

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

• Manage subject enrollment, retention, and compliance.

• Assist with TMF management and oversee 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 meetings.

• Carry out additional tasks as assigned.

⛳️ Requirements

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

• A minimum of 10 years of experience in the pharmaceutical/biotechnology/CRO industry, including at least 5 years in clinical project management.

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

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

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

• A self-motivated individual who excels in a collaborative, yet less structured team environment.

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

• Proficient command of English, both written and verbal.

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

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

• Permanent authorization to work in the U.S.

• Bachelor of Science in Biology, Biotechnology, Life Sciences, or Pharmacy.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance plans.

• Generous paid time off and holidays.

• Opportunities for professional development and career advancement.

• A collaborative and inclusive work environment.