Global Clinical Project Manager

NEUROTECH U S A

About The Position

Neurotech Pharmaceuticals is an innovative biopharmaceutical company located in Cumberland, RI and Needham, MA, within Greater Boston’s vast biotechnology landscape. Since our inception more than 20 years ago, we have been developing a proprietary drug delivery platform for treatment of a variety of retinal disorders. Our drug delivery platform - Encapsulated Cell Technology (ECT) platform is designed to deliver genetically modified therapeutics to slow the progression of chronic retinal diseases. Our most advanced program is delivering a neurotrophic factor to treat the orphan disease Macular Telangiectasia Type 2 (MacTel) For over two decades, we have pioneered the development of our proprietary Encapsulated Cell Therapy (ECT) platform, designed to address chronic retinal diseases. Our lead program focuses on Macular Telangiectasia Type 2 (MacTel), a rare retinal disorder, leveraging ECT's innovative approach to provide sustained, targeted treatment directly to the eye. Neurotech is seeking a Senior Global Clinical Project Manager (Global CPM) reporting to the VP of Clinical Operations. The Global CPM is responsible for leading and managing the execution of global Phase 3 and/or Phase 4 clinical studies from protocol inception through study closure. The Global CPM will oversee multi-million dollar projects involving multiple vendors (3+), ensuring high-quality execution while fostering relationships to make Neurotech the Sponsor of choice for clinical sites. This role requires a seasoned clinical operations professional with extensive experience managing global studies, cross-functional teams, and complex clinical programs. The Global CPM will also serve as a mentor to junior Clinical Project Managers (CPMs) and other team members, providing strategic guidance, professional development, and training to support the growth of the Clinical Operations team.

Requirements

Prefer a BA/BS, BSN, or related degree with at least 8 years relevant clinical experience, with at least 5 years in clinical project management
Expertise in clinical trial operations, including ICH-GCP, FDA, EMA, and other regulatory requirements.
Strong leadership and strategic thinking skills with the ability to proactively identify and address challenges.
Exceptional project management skills, with a proven ability to deliver on complex programs within scope, budget, and timelines.
Vendor selection and oversight experience, including CROs, central labs, and imaging vendors.
Strong negotiation skills in managing contracts, budgets, and vendor relationships.
Excellent communication, writing, and presentation skills with experience engaging key stakeholders.
Experience with eTMF software, document management systems, and clinical trial data platforms.

Nice To Haves

Experience with biologic products, surgically implanted devices, and rare diseases is a plus.

Responsibilities

Oversee the full life cycle of global Phase 3 and/or Phase 4 clinical trials and other trials as assigned, ensuring studies remain on track with timelines, budgets, and regulatory requirements.
Provide strong guidance and mentorship to Junior Clinical Project Managers (CPMs), ensuring they effectively execute project activities, adhere to timelines, and develop critical problem-solving skills. While this role does not have direct reports, the Global CPM will play a key leadership role in supporting the professional growth and operational effectiveness of junior team members.
Oversee all clinical vendors (e.g., CROs, central labs, imaging centers) and clinical sites involved in the assigned trials, ensuring seamless collaboration and high performance.
Develop and execute vendor oversight plans, including contract negotiations, budget management, and performance assessments.
Strengthen relationships with investigative sites, ensuring Neurotech is positioned as a Sponsor of choice for future collaborations.
Maintain tracking systems for critical operational functions.
Monitor clinical trial metrics, risks, and performance indicators, proactively identifying and mitigating risks to avoid study delays.
Drive inspection readiness efforts in preparation for regulatory submissions (e.g., BLA submission).
Lead cross-functional project team meetings, ensuring clear communication and alignment across Clinical, Regulatory, Medical Affairs, and other departments.
Develop and maintain study documents, including protocols, informed consent templates, project plans, and clinical operations SOPs.
Manage multi-million dollar clinical trial budgets, including review of vendor invoices, budget forecasting, and financial reconciliation.
Analyze and coordinate vendor change orders, ensuring appropriate cost management and value-driven decision-making.
Ensure investigational product distribution, accountability, and compliance with study-specific requirements.
Maintain oversight of eTMF organization and clinical trial documentation compliance with ICH GCP and regulatory expectations.
Drive initiatives to improve operational efficiency and quality in clinical trials.
Represent Neurotech at investigator meetings, industry conferences, and vendor oversight meetings as needed.
Perform other duties as assigned.