Sr. Associate Manager, Clinical Research Specialist (6-Month Contract)

Mannkind Corporation - Westlake Village, CA

Full-time

Remote - Westlake Village, CA

Chemical Manufacturing

About the position

The Clinical Research Specialist at MannKind plays a crucial role in supporting clinical research operations, ensuring compliance with regulatory standards, and contributing to the success of clinical trials. This position involves biostatistical analysis, publication preparation, and collaboration with cross-functional teams to ensure the safety and effectiveness of MannKind products throughout various phases of clinical trials.

Responsibilities

• Provide comprehensive operational support for clinical research projects, including study planning, execution, and monitoring.
• Perform biostatistical analysis using tools such as SAS, R, Python, and Excel to interpret clinical data and generate meaningful insights.
• Contribute to the preparation of clinical study reports and publications, ensuring clarity, accuracy, and compliance with regulatory standards.
• Assist in drafting protocols, informed consent forms, and other study-related documents.
• Coordinate the submission of content (abstracts, posters, etc.) to conferences, ensuring adherence to submission guidelines and timelines.
• Oversee data collection, validation, and management processes to maintain data integrity and quality.
• Utilize electronic data capture (EDC) systems and ensure compliance with data protection regulations.
• Work closely with cross-functional teams, including clinical operations, regulatory affairs, and medical affairs, to ensure seamless project execution.
• Participate in project meetings and provide statistical and operational insights.
• Ensure all clinical research activities adhere to applicable regulatory requirements and company policies.

Requirements

• Requires a four-year degree in biological, physical, engineering sciences or related discipline.
• 4+ years of relevant clinical research experience directly supporting clinical study conduct with a focus on biostatistics and analysis is preferred.
• 2+ years with MS degree is preferred.
• Proficiency in SAS, R, Python, Excel, and other statistical analysis tools.
• Demonstrated ability to analyze and interpret data and communicate conclusions clearly and concisely.
• Demonstrated ability to prepare and submit content to conferences.
• Familiarity with submission guidelines and processes for various scientific congresses and journals.
• Experience with EDC systems and clinical trial management software (e.g., Medrio, Medidata, Oracle Clinical).
• Requires excellent verbal and written communication skills and interpersonal skills to build/maintain strong relationships with clinical sites, vendors, patient advocacy groups and internal team.
• Knowledge of GCP and regulatory compliance guidelines for clinical trials (e.g. applicable ISO Standards, FDA).
• Demonstrated ability to work effectively within multidisciplinary teams.
• Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
• Demonstrated ability to solve problems and manage multiple tasks, with strong attention to detail.

Nice-to-haves

• Knowledge and experience with diabetes and/or orphan lung therapeutic area preferred.