Senior Clinical Project Manager

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

📋 Description

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

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

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

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

• Supervise and provide support to Clinical Assistants, In-house Clinical Research Associates, and Clinical Research Associates.

• Oversee and train Associate CPMs, offering guidance to CPMs.

• Develop and evaluate clinical study documents, protocols, ICF templates, budgets, site templates, manuals, plans, and binders.

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

• Deliver accurate reports, work products, and monthly billing information to the finance department.

• Present at investigator meetings and meetings with new clients.

• Keep management updated through regular communication.

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

• Manage subject accrual, retention, and compliance.

• Assist with TMF management and reviews.

• 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 various other meetings.

• Carry out additional responsibilities as assigned.

⛳️ Requirements

• BS/BA degree 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, or CRO industry, including at least 5 years in clinical project management.

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

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

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

• A self-starter who excels in a collaborative yet less structured team setting.

• Competent in solving unstructured or ambiguous challenges.

• Strong command of the English language, both spoken and written.

• Excellent communication and interpersonal skills with a customer service orientation.

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

• Permanent authorization to work in the U.S.

• Bachelor's degree in Biology, Biotechnology, Life Sciences, Pharmacy, or a related field, or equivalent experience.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career advancement.

• Flexible work arrangements and a collaborative team environment.