Catalyst Clinical Research is hiring a
Project Manager

Summary

The job is for a Project Manager responsible for the successful delivery of clinical trials according to contractual agreements. The role involves leading cross-functional teams, managing vendors, and understanding client expectations while ensuring compliance with ICH GCP guidelines.

Requirements

• Minimum of a BS/BA in a biomedical discipline or equivalent education/training is required
• Minimum of 5 years’ experience with clinical research methodology and product development activities (IND filing, study design, monitoring, study coordination, data management, data analysis, NDA submissions). Prior project management or project lead coordination experience is required
• Proficient with Microsoft Office Suite
• Excellent written and oral communication skills
• Demonstrated proficiency in communicating with and motivating multiple partners/vendors/outsource partners
• Strong organizational, problem-solving, and analytical skills
• Versatility, flexibility, and a willingness to work within constantly changing priorities
• Proven ability to handle multiple projects and meet deadlines
• Exceptional attention to detail
• Demonstrated track record in leading successful teams to achieve aggressive timelines using creative problem-solving techniques
• Collaborative leadership style
• Ability and willingness to travel as needed
• Ability to work independently and as a member of various teams and committees
• Good judgement with the ability to make timely and sound decisions

Responsibilities

• Plan, track, and deliver efficient and high-quality trial execution of all operational aspects of assigned clinical trials/programs from protocol inception through Clinical Study Report (CSR) and trial close out
• Manage and drive the Scope of Work (SOW) consistent with the targeted timelines and budget for the assigned clinical trials/programs
• Communicate to the sponsor with strict attention to budget and timeline estimates for deliverables and timely notification of changes to SOW and timelines
• Timely communications to the sponsor on all aspects of the study with a priority on communicating any patient safety issues
• Ensure the completion of all project deliverables from contract signature to delivery of final clinical study report and project close out while complying with ICH GCP requirements
• Manage study vendors, patient enrollment, and liaise with investigators and study sites
• Lead cross-functional teams while understanding and managing client expectations
• Work with the sponsor, subcontractors, and Catalyst assigned project team members to manage resources (internal and external) to meet contracted project timeline and sponsor expectations
• Proactively identify, resolve/mitigate, and escalate risks or issues when necessary and proactively communicate to the project team any issue that may negatively impact the overall project, seeking a collaborative resolution
• Perform project status tracking and reporting including participation in the monthly project review with the ELT