Manager/Sr. Manager, Clinical Document Specialist

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:

• Support the implementation and management of record management processes related to the TMF, ensuring all work is conducted in accordance with Standard Operating Procedures (SOPs), policies, GCP, applicable regulatory requirements, and meets quality and timeline metrics.
• Serve as the operational process and subject matter representative to the clinical study teams, providing direction on best practices in clinical trial documentation.
• Support the preparation and management of TMF Plans and Indexes, ensuring study team and vendor compliance.
• Manage study TMF setup, user access management, and document processing in the eTMF system.
• Perform TMF quality reviews for Sponsor Oversight, identifying document deficiencies and tracking them to resolution or rejection.
• Maintain and report TMF quality metrics for studies, creating and editing reports and dashboards to facilitate study team awareness.
• Direct and escalate quality-related concerns in gathered documentation.
• Develop expert awareness of the filing structure and navigation of the system for inspection readiness and user support.
• Oversee TMF quality for both the MannKind TMF and the CRO TMF across MannKind trials.
• Facilitate the development and maintenance of MannKind trial-specific TMF Indexes and Plans, Study Milestone Design, and Expected Document Lists.
• Coordinate with CRO and study vendors to oversee the timely completion and resolution of issues from their QC activities.
• Support study teams in activities related to ongoing TMF maintenance, close-out, transfer, and archival of study TMFs.
• Support study teams in activities related to creation, review, implementation and oversight of clinical documents required for study execution.
• Support study teams during regulatory inspections and serve as subject matter expert (SME) for Regulatory Inspection activities.
• Provide comprehensive document management support to clinical study teams by coordinating the review, tracking, and execution of Confidential Disclosure Agreements (CDAs), Clinical Trial Agreements (CTAs), vendor contracts, and study-related plans.
• Collaborate cross-functionally with legal, procurement, clinical operations, and external stakeholders to facilitate contract and plan approvals, resolve discrepancies, and ensure audit readiness of all documentation.
• Act as a key point of contact for document lifecycle tracking and contribute to continuous improvement of documentation processes and tools.

Knowledge, Experience and Skills:

• BA/BS degree with 7-11+ years or MS/MBA degree with 5-8+ years related experience in clinical document management, clinical operations, or regulatory affairs within a pharmaceutical, biotech, or CRO environment.
• Hands-on experience with document routing, version control, tracking, and archival in TMF or eTMF systems.
• Experience supporting cross-functional study teams, including legal, procurement, and clinical teams.
• Prior involvement in contract coordination or study plan review processes is highly desirable.
• Knowledge of the DIA TMF Reference Model and how documents from various functional areas map and meet TMF filing requirements.
• Knowledgeable of Good Clinical Practice (GCP), Good Documentation Practice (GDP) and FDA requirements for TMF content/structure and sponsor oversight.
• Experience in conducting/managing TMF Quality Control activities.
• Understanding of basic personal data privacy principles, including HIPAA and GDPR protections.
• Experience with managing large spreadsheets in MS Excel.
• Excellent organizational skills, ability to manage multiple tasks, and meticulous attention to detail.
• Positive, team-oriented attitude.
• Experience working in CRO-owned eTMF systems and User Access Management.
• Previous participation in the validation of electronic document management systems/TMFs.
• Experience with process implementation and management principles.
• Ability to identify process gaps and contribute to process improvements in document and contract management.

Pay Range: $112,000 - $192,000 per year