Sr. Associate Manager, Clinical Research - Westlake Village, United States - MannKind

MannKind Westlake Village, United States

3 weeks ago

Description

At MannKind our employees are our number one asset, and we continue becoming a tight-knit community where each of us plays a critical role in our collective success.

Committed to diversity, at MannKind we depend on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better.

MannKind Corporation is currently seeking a Sr. Associate Manager, Clinical Research.

This role is an integral member of the clinical operations team, supporting strategic planning for Phase 1 through 4 clinical trials to ensure the safety and effectiveness of MannKind products.

Specific activities include contributing to clinical trial plans, various aspects of clinical trial operations in collaboration with Clinical Research Organizations (CRO) and other external parties, study recruitment efforts and data analysis.

The Sr.

Associate Manager, Clinical Research provides technical and administrative support for multiple studies and must ensure that all activities are in compliance with current local and international regulations, laws, guidance (for example, FDA, ICH, CPMP etc.), and Good Clinical Practices (GCPs).

This position is contract to direct hire.

Essential Duties and Job Functions:

Assists with the development and management of study related documents including clinical protocols, case report forms, study manuals, operational plans, recruitment content, and other study materials.

Ensures readiness of study supplies, study tools, devices, and investigational products (IP) for use in clinical trials.
Tracks and reports progress of studies including site certifications, subject enrollment, data collection, documentation of adverse events, and real-time study data
Creates and maintains registry postings, such as
Initiates contracts and provides operational oversight of vendors and other external third parties such as patient advocacy groups and CROs
Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for study related meetings
Maintains relationships and addresses questions regarding procedural issues from clinical sites and helps identify areas of improvement
Assists in the identification and assessment of clinical sites for study participation
Supports site certification procedures including Investigator Meeting and Site Initiation Meeting planning, and preparation and presentation of training materials
Manages and maintains study Trial Master Files (TMF), including scheduled reconciliation, and escalates any issues to study leads
Assists in the preparation and review of regulatory documents (for example IND annual reports, safety reports, Investigator Brochures, etc.)
Supports data analysis, research, and scientific exchange through statistical analysis, literature research, and scientific publication
Contributes to process improvement initiatives, SOP development, and document revisions

Knowledge, Experience and Skills:
Requires a four-year degree (in biological, physical, engineering sciences or related discipline) and related experience in clinical operations such as in a pharmaceutical, medical device, research, or academic

3+ years of relevant clinical operations experience directly supporting clinical study conduct
1+ years of relevant clinical operations experience directly supporting clinical study conduct with a MS degree
No additional experience with a PharmD degree

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
Demonstrated ability to be a fast learner, with strong attention to detail
Demonstrated ability to solve problems and manage multiple tasks
Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed
Demonstrated ability to analyze and interpret data and communicate conclusions clearly and concisely
Demonstrated ability to work effectively within multidisciplinary teams
Proficient in Microsoft Office products (Word, Excel, PowerPoint, etc.), including SharePoint and other collaboration tools.
Knowledge of GCP and regulatory compliance guidelines for clinical trials (e.g. applicable ISO Standards, FDA) preferred
Knowledge and experience with diabetes and/or orphan lung therapeutic area preferred

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