Piper Companies

Project Manager, Data Management & Regulatory Use

Piper Companies United States

Piper Companies is currently seeking a Project Manager, Data Management & Regulatory Use for a remote opportunity to join a non-profit research group dedicated to saving cancer patients by facilitating access and promoting participation in oncology clinical trials..

Responsibilities of the Project Manager, Data Management & Regulatory Use

  • Manage, mentor, and train data management staff, develop SOPs, and oversee data management projects
  • Act as a liaison with industry sponsors, Medidata Rave, and study builders for data management deliverables
  • Review and develop standard library of CRFs, edit checks, and functions while ensuring CDASH/CDISC compliance
  • Assist in implementing clinical study databases, provide input for process improvement, and manage department SOPs
  • Participate in meetings, industry collaborations, training assessments, hiring processes, and special projects

Qualifications of the Project Manager, Data Management & Regulatory Use

  • 5+ years of data management experience for oncology clinical trials, preferably in a pharmaceutical company or CRO
  • Possess a thorough understanding of data collection practices for oncology-specific trials, global data management practices, and regulatory requirements
  • Medidata Rave experience, with Medidata certification in data management
  • Bachelor’s degree or equivalent work experience required

Compensation for the Project Manager, Data Management & Regulatory Use

  • Salary Range: $100,000 - $120,000
  • Benefits: Comprehensive package includes Medical, Dental, Vision, 401k, Paid Time Off, and Tuition Reimbursement

Keywords: clinical research, clinical, oncology, cancer, oncology clinical trials, clinical trials, clinical project management, project management, PM, CPM, data management, data manager, regulatory use, RU, manager, people management, supervisor, budgets, fiscal, clinical research trials, pharma, pharmaceutical, CRO, clinical research organization, data collection, medidata rave, global trials, SOP, work instructions, mentoring, regulatory, industry liaison, rave, study build, CRF, edit checks, CDASH, CDISC, compliance, SDTM, WI, case report forms, Clinical Data Acquisition Standards Harmonization, Clinical Data Interchange Standards Consortium

  • Seniority level

    Mid-Senior level
  • Employment type

    Full-time
  • Job function

    Project Management and Information Technology
  • Industries

    Staffing and Recruiting

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