What are the responsibilities and job description for the Sr. Manager, Clinical Document Specialist (Remote) position at Mannkind Corporation?
Position: Sr. Manager, Clinical Document Specialist (Remote) | ||
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Job Id: 111255 | ||
# of Openings: 1 | ||
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:
MannKind Corporation is seeking a detail-oriented and highly organized Clinical Document Specialist (CDS) to join our clinical operations team at MannKind Corp. The CDS will play a crucial role in supporting the implementation and management of record management processes related to the Trial Master File (TMF), ensuring compliance with internal policies and external regulations, audit readiness, as well as supporting clinical operations with study document review, oversight and execution. The role will be responsible for managing all TMF operations and is accountable for TMF quality, inspection readiness, and compliance. This role involves close collaboration with the Director of Clinical Operations, and the clinical study teams to ensure best practices in documentation and operational excellence.
Essential Duties and Job Functions:
Knowledge, Experience and Skills:
#LI-Remote
#LI- Hybrid
#LI-Onsite
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Pay Range: $128,000 - $192,000 per year | ||
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Mannkind Corporation is proud to be an Equal Employment Opportunity employer. We provide equal employment opportunity (EEO) to all persons regardless of race, creed, color, religion, national origin, ancestry, gender (including pregnancy, breastfeeding or medical condition related to pregnancy or breastfeeding), age, physical or intellectual disability, sexual orientation, gender identity, gender expression, gender stereotyping, marital status, military or veteran status, citizenship, genetic characteristic or information, or any other characteristic protected by applicable federal, state, or local law.
Salary : $128,000 - $192,000