
201 - 500 employees
đĄ Telecommunications
⥠Energy
âď¸ SaaS
đ° $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 â including AI-enabled automation and data-driven tools â to help operators modernize billing, monetization, and customer fulfillment processes with a SaaS and cloud-focused delivery model.
đĽ 0 minutes ago
đ Massachusetts â Remote
âł Contract/Temporary
đ Senior
đĽ Clinical Operations
đť Ghost score 10%
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201 - 500 employees
đĄ Telecommunications
⥠Energy
âď¸ SaaS
đ° $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 â including AI-enabled automation and data-driven tools â to help operators modernize billing, monetization, and customer fulfillment processes with a SaaS and cloud-focused delivery model.
⢠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
⢠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
⢠7 Months Contract
Apply Nowđ October 1
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