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Senior Clinical Project Manager

Job not on LinkedIn

🔥 0 minutes ago

🍂 Massachusetts – Remote

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⏳ Contract/Temporary

🟠 Senior

🏥 Clinical Operations

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Logo of Sigma Systems

Sigma Systems

201 - 500 employees

📡 Telecommunications

⚡ Energy

☁️ SaaS

💰 $11M Venture Round - Tribold on 2009-01

Telecommunications • Energy • SaaS

Sigma Systems is a software company that provides cloud-native, API-driven BSS/OSS, product catalog, CPQ and order orchestration solutions for communications service providers and energy/utilities companies. It offers modular, TMF-compliant components and managed services — including AI-enabled automation and data-driven tools — to help operators modernize billing, monetization, and customer fulfillment processes with a SaaS and cloud-focused delivery model.

📋 Description

• Oversee Investigator Initiated Studies, Collaborative Research, and Expanded Access Programs • Provide operational oversight across study planning, execution, monitoring, and closeout • Lead cross-functional collaboration with Medical Affairs, Clinical Operations, R&D, Clinical Supply, Pharmacovigilance/Safety, Regulatory, Legal, Finance, and other functions • Serve as operational point of contact for investigators and external research partners • Monitor study milestones, enrollment, timelines, study drug accountability, contracts, and deliverables • Identify study risks and operational issues; develop mitigation and contingency plans and escalate significant issues • Drive alignment on study requirements, timelines, responsibilities, risks, decisions, and next steps • Assess study drug requirements, supply availability, expiration considerations, and supply risks • Negotiate and finalize Clinical Trial Agreements and study budgets • Monitor budgets and track contractual milestones, deliverables, payments, and financial obligations • Prepare and maintain study documents and correspondence • Participate in study team and investigator meetings • Prepare and deliver portfolio and study updates to stakeholders and leadership • Coordinate internal review of manuscripts, abstracts, presentations, and other scientific deliverables • Support CyberGrants Portal submissions and serve as backup administrator • Ensure studies comply with regulations, internal requirements, contracts, and procedures • Support regulatory inspections and audits • Lead or contribute to SOP, process, tool, template, and workflow development and continuous improvement • Provide training on applicable procedures • Maintain oncology and pharmaceutical regulatory knowledge • Serve as a subject matter expert, provide guidance, knowledge sharing, and mentorship • Perform other duties requested by senior management

🎯 Requirements

• BS./M.S./Ph.D. in a related life science discipline is preferred • Thorough understanding of the oncology arena • Minimum of 3-5 years of industry experience in clinical drug or program development or equivalent academic experience in clinical trials • Proven leadership skills, executive presence, maturity, emotional intelligence, and written/oral communication skills • Demonstrated skills working within a matrix environment • Ability to work collaboratively with investigators, CROs, vendors, and parent-company team members in Japan • Interpersonal skills and influence to accomplish work without formal authority and ensure optimal team performance • Strong experience facilitating project team meetings, cross-functional communication and decision making, and ensuring stakeholder alignment • Strong attention to detail and ability to establish priorities, schedule, and meet deadlines • Sound judgment, problem solving, leadership, and collaboration in selecting methods and techniques for obtaining solutions • Familiarity with the design and conduct of clinical trials and project management in relevant therapeutic areas • Experience evaluating clinical trial outcomes and basic knowledge of clinical trial outcome standards • Strong analytical skills with a data-driven approach to planning, execution, and problem solving • Working knowledge of current global regulatory requirements and guidelines for clinical trials

🏖️ Benefits

• 7 Months Contract

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