Senior Clinical Project Manager

Azurity Pharmaceuticals - US•Woburn, MA

2d•Hybrid

About The Position

The Senior Clinical Project Manager, Clinical Development is responsible for leading the planning, execution, oversight, and delivery of domestic and/or global postmarketing required clinical trials. The Sr. CPM serves as the operational leader for assigned studies, partnering cross-functionally with Medical/Drug Safety, Regulatory, Data Management, Quality, and external vendors to ensure clinical trials are delivered on time, within budget, and in compliance with applicable regulations and quality standards.

Requirements

Bachelor's degree in Life Sciences or a related scientific discipline (advanced degree preferred).
8+ years of Clinical Trial / Project Management experience within CRO, biotechnology or pharmaceutical organizations.
Demonstrated experience operating at a Senior Clinical Trial Lead or Associate Director level.
Proven leadership of global clinical studies and cross-functional project teams.
Strong experience managing CROs, vendors, and external partners.
Extensive knowledge of ICH-GCP, FDA, EMA, and global clinical trial regulations.
Excellent communication, leadership, and project management skills.

Nice To Haves

5+ years’ experience of clinical trial management for late phase studies
Experience with IMP/clinical drug supply logistics, planning, and labeling activities in late phase studies
Effective communicator who can manage multiple priorities while building strong internal relationships across multiple departments

Responsibilities

Lead the operational execution of assigned domestic or global, multi-center late phase clinical trial(s) including oversight of selected vendor(s)/CRO to ensure accountability, quality, and on time delivery of key project deliverables.
Develop and manage study timelines, contract/budget negotiations, and risk mitigation plans to ensure delivery on timeline and financial goals are met.
Initiate and manage request for proposal activities for assigned clinical studies or clinical development vendors, including CROs, specialty lab vendors, bioanalytical vendors, etc.
Lead study execution team comprised of cross-functional representatives from Regulatory, Drug Safety, Medical, Drug Supply, Data Management, Biostatistics, and Quality to oversee CRO vendors and ensure study excellence.
Manage clinical development vendors according to vendor oversight plans.
Oversee all study-level data monitoring activities, reviews monitoring visit reports, and conducts Sponsor oversight monitoring visits as required.
Responsible for monthly Protocol Deviation (PD) review, including oversight of CRA documentation and collaboration with Medical Monitor for medical review.
Prepares and/or reviews study-related study plans/documents; reviews site study documents.
Assist in strategic trial design and protocol writing.
Strategic country/site selection with program input and ensuring consistency across all clinical projects for therapeutic area.
Ensures all clinical trials are executed in compliance with ICH/GCP guidelines/regulations and applicable SOPs: participates in the planning of quality assurance activities and coordinates resolution of audit findings; ensures audit-ready condition of clinical trial documentation including central clinical files, Trial Master File (TMF), and clinical trial registry submissions.
Ensure inspection readiness and compliance with ICH-GCP, FDA, EMA, and applicable regulatory requirements.