MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies - dry-powder formulations and inhalation devices - offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication.
Position Summary:
The Associate Director/Director Clinical Data Systems will be responsible for specifying, developing, validating and executing programs related to clinical systems and applications. The position will be responsible from start to finish Medidata programming activities to align on and drive data collection requirements for one or more studies.
This position will work in a team to develop databases in which clinical data are captured and processed for analysis and reporting. This role requires the ability to work independently and to take initiative in managing delivery timelines. This position plays a critical role on our study teams; a quality, timely database development is instrumental to the company's and study's success.
This position is remote.
Essential Duties and Job Functions:
- Participate in the development, maintenance and compliance of database builds and Electronic Data Capture (EDC) standards in support of clinical studies, including but not limited to Edit Checks and CRF modules
- Act as a resource for database issues and provide problem-solving with clinical database technology, capabilities and functionality
- Maintain all project documentation as required by SOP and processes
- Recommend process improvements leading to more efficient and timely database builds and post-production changes
- Be an active part in multiple global project teams and collaborate with internal team members
- Manage programming data imports/exports from various sources, develop complex subject profiles/cohorts, and creating listings in multiple output formats like SAS, PDF and XML
Knowledge, Experience and Skills:
- Bachelor's degree in computer science, mathematical science, life science, or related field
- 10+ years working in GXP related environments/pharmaceutical industry
- 10+ years of programming experience in Medidata Rave in the clinical research environment preferred, but not required
- Experience with SQL scripting/Clinical SAS programming
- C#, or similar, programming experience preferred, but not required
- Flexible and able to support a variety of studies
- Ability to act independently and with initiative
- Knowledge of EU regulatory agencies, FDA/ISO guidelines and industry standard practices regarding data management
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Mannkind Corporation
Jul 03, 2025