Job Description

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 CRA who will act as an expert advisor on ICH GCP, MannKind SOP's, and have experience at all stages of monitoring including feasibility, study start up, interim study conduct and study close out. This position has local responsibility for the delivery of the studies at allocated sites and is an active participant in local and global country teams(s). This position will also become involved, when required, in other areas of study management, staff training and other clinical operation activities as the needs arise. As a member of MannKind this position is expected to embrace and contribute to our culture of process improvement with a focus on streamlining process.

Essential Duties and Job Functions:

• Independently and proactively co-ordinate all necessary activities for study conduct on all study Phases I-1V both remote and on-site
• Assist in identifying, selecting, and managing investigational sites
• Provide support for study sites, and internal teams with audits/inspections preparation/responses and quality issues, as needed, and follow-through with audit/inspection findings to resolution as needed.
• Following quality issue processes by escalating systematic or serious quality issues, data privacy breaches, or ICH-GCP compliance issue to applicate group (ie: Clinical Trial Lead, Quality, etc.)
• Ensure agreed monitoring KPIs are observed and remain within the agreed quality acceptable ranges (ie: action items aging, SDV metrics, date entry metrics, query aging, MV reports metrics, etc.)
• TMF experience in ensuring timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, MannKind SOPs and local requirements
• Expert knowledge of MannKind SOP's and guidance documents, ICH GCP and appropriate regulations
• Training, supporting and advising investigators and site staff in study related matters, including Risk Based Quality Management (RBQM) principles.
• Maintain timelines and study milestones
• Ensure accuracy and completeness of data through familiarity with RBM
• Participate in training and mentoring new staff up to Clinical Research Associate level as appropriate
• Assist in contributing to and delivering study plans for all phases of a trial
• Ensure all aspects of the clinical trial are conducted in accordance with relevant regulations, including but not limited to FDA and EMA, as well as ethical guidelines.
• Ability to provide constructive feedback to site staff and follow issues noted through to resolution
• Excellent communication skills, including effective and appropriate client interaction
• Design participant information worksheets and consent forms where applicable
• Ability to motivate investigators to achieve or surpass recruitment targets
• Document barriers and mitigate recruitment barriers by implementing initiatives to improve recruitment
• Consistently keep Clinica Trial Lead and team informed of significant issues
• Participate, if requested, in preparation of and review of any study specific documentation such as draft protocol, CRF's, monitoring guidelines, etc.
• Maintain sponsor and participant confidentiality
• Assume additional responsibilities as directed by Clinical Trial Lead
• Be mindful of cost effectiveness with travel
• Assist with marketing the company and attending conferences, when appropriate
• Other duties as assigned

Knowledge, Experience and Skills:

• BS/BA in a relevant scientific discipline; Minimum of 5-7 years of (CRA) monitoring experience in the pharmaceutical or CRO Industry
• Ability and willingness to travel 60-70% of the time which includes both driving and flying across North America as this is not a regional based position
• Ability to fly international, if required
• Valid driver's license and passport
• Excellent knowledge of local regulations; ICH-GCP
• Foundation of rare disease medical knowledge and foundational understanding of the drug development process. Excellent understanding of Clinical Study management including monitoring, study drug handling and data management with the ability to collaborate across teams and disciplines
• Excellent written and verbal communication skills
• Highly organized with the ability to prioritize and multi-task
• Impressive negotiation skills

#LI-Remote

Pay Range: $80,000 - $120,000 per year

Job Tags

Full time, Interim role, Local area, Remote work,

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