Senior Clinical Project Manager

Azurity Pharmaceuticals - US; Woburn (MA); Hybrid; USD 130,000 - 185,000; Full time

Job summary

Azurity Pharmaceuticals - US is seeking a Senior Clinical Project Manager to lead planning, execution, and delivery of domestic and global late-phase trials. You will partner with Regulatory, Medical, Drug Safety, Data Management, and CRO vendors to ensure trials meet timelines, quality standards, and budget expectations.

The role requires 8+ years in clinical trial management, strong leadership, and deep knowledge of ICH-GCP and regulatory requirements.

Qualifications

• 8+ years of Clinical Trial / Project Management experience.
• Experience at Senior Clinical Trial Lead or Associate Director level.
• Proven leadership of global clinical studies and cross-functional teams.
• Experience managing CROs, vendors, and external partners.
• Extensive knowledge of ICH-GCP, FDA, EMA and global trial regulations.
• Excellent communication and leadership skills.

Responsibilities

• Lead domestic or global late-phase clinical trials and manage CROs/vendors to ensure on-time, within-budget delivery.
• Develop and manage study timelines, budgets, and risk mitigation plans.
• Oversee study documentation, TMF readiness, and regulatory/compliance processes.
• Coordinate cross-functional study teams across Regulatory, Drug Safety, Medical, and Data Management.
• Support strategic trial design, protocol writing, and site/country selection.

Skills

Senior leadership

Project management

Vendor management

Cross-functional leadership

Communication

ICH-GCP knowledge

Regulatory knowledge

Global study leadership

Education

Bachelor's degree in Life Sciences

Advanced degree preferred

Tools

FDA/EMA regulatory knowledge

Job description

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com .

Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.

“Azurity roles are office based and are generally require individuals to be in office Tuesday through Thursday with Monday and Friday as optional days.”

About the Role

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.

Key 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.

Required Skills and Experience

• 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.

Preferred Qualifications

• 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

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Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Azurity Pharmaceuticals - US’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.