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 Senior Clinical Data Manager provides clinical data expertise to project teams in an outsourced and/or insourced Clinical Data Management model. The successful candidate will have advanced knowledge of end-to-end clinical research lifecycle and Clinical Data Management processes, as well as global regulatory, and industry rules and guidance (i.e. ICH, GCP) to support drug or biologics development. This role is responsible for managing Data Management components of projects, including vendor performance for outsourced projects. This position may mentor Clinical Data Management team members and may direct activities of Arcus Clinical Data Management vendors. The incumbent may contribute to department initiatives and non-study projects.
Essential Duties and Job Functions:
- Support all Data Management activities for assigned projects, including outsourced and/or insourced models. May act as the Lead Data Manager or Support Data Manager on insourced studies and act as Oversight Data Management Lead or support for outsourced studies.
- Actively participate in cross functional teams as the Data Management subject matter expert. This includes providing accurate Data Management updates and timelines during each stage of the study lifecycle, proactive communication for all Data Management topics, and complex risk assessment and mitigation planning with a firm awareness of cross functional impact.
- Lead and/or support Data Management start-up activities, such as development and review of protocols, EDC database development documentation and activities, eCRF Completion Guidelines, Data Management Plans, and cross functional collaboration.
- Ensure data collected in the clinical and vendor databases meets the requirements for analysis, including development and maintenance of Data Transfer Agreements and vendor data transfer workflow.
- Participate in all aspects of data cleaning and review, including routine data cleaning, third party data reconciliation, query management, metrics reporting, and cross functional data health communication and documentation.
- Review and contribute to cross functional study documents, such as Protocols, Clinical Monitoring Plans, Statistical Analysis Plans, Safety Monitoring Plans, Investigator Brochures, Data Safety Update Reports, publications and presentation slide decks.
- Maintain all Data Management documentation, ensuring preparedness for regulatory inspections.
- Collaborate with internal and external stake holders for data transfers and data analytics activities.
- May develop, review, and revise SOPs, Work Instructions, and Templates.
Knowledge, Experience and Skills:
- Bachelor's Degree, or commensurate experience, with at least 5 years' experience in Clinical Data Management with a Pharmaceutical, Biotech, CRO, or Academic Center.
- Excellent verbal and written communication skills. Ability to communicate Data Management and EDC technical concepts to cross functional groups for awareness and understanding.
- Highly organized, collaborative, detail-oriented, outcome-oriented, and self-motivated.
- Ability to prioritize, adapt, and evolve tasks and processes in a fast-paced environment.
- Effectively manage a variety of Data Management tasks for multiple clinical studies at different stages of activity.
- Robust experience with EDC systems, including Medrio and Medidata.
- Advanced awareness of data collection and data cleaning best practices.
- Firm understanding and proven success managing vendors and data transfer workflows.
- Practical knowledge of ICH, FDA, and GCP regulations and guidelines, and general knowledge of industry data collection and reporting standards and best practices, such as SDTM and CDISC/CDASH.
- Less than 20% travel is required.
Physical Requirements: Must possess mobility to work in a standard office setting and use standard office equipment, including a computer; vision to read printed materials and a computer screen; and hearing and speech to communicate in person, before groups, and over the telephone. This is primarily a sedentary office classification although standing in work areas and walking between work areas may be required. Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard, mouse, or calculator, and to operate standard office equipment. Positions in this classification occasionally bend, stoop, kneel, reach, push, and pull drawers open and closed to retrieve and file information. Employees must possess the ability to lift, carry, push, and pull materials and objects weighing up to 25 pounds.
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Mannkind Corporation
Jul 03, 2025