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Patient Registry Study Manager

Company

Reata Pharmaceuticals, Inc.

Address Plano, TX, United States
Employment type FULL_TIME
Salary
Category Pharmaceutical Manufacturing
Expires 2023-06-21
Posted at 1 year ago
Job Description
Join Us | Reata Pharmaceuticals


As a commercial pharmaceutical company, we are committed to positively impacting the lives of patients with life-threatening diseases. With rigorous science and research as our foundation, we are a diverse team of problem solvers, trailblazers, and people who want to make a difference in the lives of patients. Having received our first drug approval in the U.S., we are focused on global expansion. In 2021, we established our European regional office in Zug, Switzerland.


What You Will Do | Responsibilities


As our Patient Registry Study Manager, you will be responsible for ensuring logistical support for the patient registry study throughout study start-up, conduct, and close-out. In this role, you will have the opportunity to function with moderate supervision, collaborating with inter- and intra-departmental resources, patient advocacy groups, and site personnel to ensure quality deliverables, project timelines, and needs are being met.


  • Support and interact directly with vendors involved in the conduct of studies
  • Collaborate closely with internal and external stakeholders to effectively support assigned studies
  • Draft agendas and record minutes from study meetings
  • Additional duties and responsibilities as assigned
  • Organize and maintain accurate tracking systems and tools to support the conduct of a clinical study from start-up to close-out
  • Communicate regarding trial start-up, conduct, and close-out activities
  • Interact directly with the CROs that are involved in the study
  • Participate in Operations meetings and training initiatives, project team meetings, and maintain relationships with other departments and clients
  • Assist in the management and tracking of study-specific site payments
  • Manage and maintain clinical and non-clinical supplies
  • Provide support to vendors, sites, and patient advocacy groups
  • Collect and review regulatory documents from clinical sites – for completeness and accuracy
  • Participate in department system/standards improvement activities


Along with a highly developed quality and entrepreneurial mindset, you will be a leader who is collaborative, strategic, and accountable, delivering results in an ethical and positive manner…


What We Are Looking For | Experience


  • GCP and regulatory knowledge including FDA and ICH regulations
  • 2+ years of accumulated clinical trial support experience, which may include Site, CRO, Pharma, Biotech, and/or IRB-related experience


What We Are Looking For | Skills & Work Style


  • Professional demeanor, strong communication skills (both written and verbal), and strong interpersonal skills including diplomacy
  • Rely on experience and judgment to plan and accomplish goals
  • Strong analytical and problem-solving skills
  • Ability to prioritize multiple tasks, plan proactively and accomplish goals using well-defined instructions and procedures
  • Detail-oriented
  • Working knowledge and experience with Word, PowerPoint, and Excel


What We Are Looking For | Education


  • Bachelor’s Degree or equivalent work experience, required


Location | Travel


  • 10-20% travel
  • Remote or hybrid


Reata Rewards for You | Benefits


  • Diverse and inclusive community focused on innovation, research, and teamwork
  • Opportunity for growth, development, and ability to expand your career and expertise
  • Generous Total Rewards Plan – including health insurance, equity, 401k match, work/life balance, and career benefits


Become a trailblazer | Make a difference | www.ReataPharma.com


Reata Pharmaceuticals is an equal-opportunity employer committed to creating an inclusive environment for all employees.