Senior Project Manager (Midwest or West Coast)

Broad Purpose

Avance Clinical is a Contract Research Organisation that supports drug development for the pharmaceutical and biotechnology industry. The Senior Project Manager I (Snr PM I) oversees project delivery, manages project finances, and ensures compliance with protocols and regulations.

Core Responsibilities

• Autonomously manage project delivery from start to finish, coordinating with internal and external stakeholders.
• Maintain effective communication with sponsors to manage project timelines, risks, and issues.
• Develop and review study plans and documents to support clinical operations.
• Identify, evaluate, and control project risks, and ensure protocol deviations are documented and reviewed.
• Oversee and lead clinical operations for single-site studies, developing and reviewing monitoring visit reports.
• Manage project financial performance, including revenue recognition, contract management, and site payments.
• Review and/or oversee site budgets and clinical trial agreements.
• Review study protocols and other relevant documents.
• May lead larger, more complex studies or those involving multiple regions.
• Participate in study-specific or vendor audits and address audit observations.
• Report Serious Adverse Events as required by protocol.
• Provide guidance and mentorship to less experienced project management staff.
• Perform other duties as directed by line management or delegated based on skills, experience, and qualifications.

Qualifications, Skills, And Experience

• Bachelor's degree in life sciences, pharmacy, nursing, or equivalent field.
• At least 3-5 years of experience as a PM in a CRO or Pharma company.
• Previous PM-related line management experience is desirable.
• Previous experience as a CRA is highly regarded.
• Clear understanding of ICH GCP and applicable regulatory requirements.
• Strong written and oral communication skills, including the ability to inform stakeholders of project updates.
• Demonstrated problem-solving and judgment abilities.
• Understanding of privacy legislation applicable to the clinical trial environment.
• Ability to work under pressure in a multi-disciplinary team environment.
• Willingness to travel (optional).