As a pivotal member of Alkahest’s Clinical Operations Team, you will be responsible for a wide variety of traditional and non-traditional CTM activities.
From the management of Phase I-III clinical trials, clinical vendor oversight, development of clinical SOPs, regulatory support and even tactical plan development and execution, this is a unique opportunity to immerse yourself in the drug development process at an exciting, innovative, and financially secure startup.
Your primary responsibilities will be to provide exceptional oversight of all aspects of study management in a largely outsourced clinical model, ensuring compliance with SOPs, GCP, and protocol requirements.
This is truly a once in a lifetime opportunity for a high performing team player to make a difference in the development of transformative therapies targeting neurodegenerative and age-related diseases.
Specific responsibilities include, but are not limited to :
Manage the start-up, ongoing day-to-day activities, close-out and reporting of assigned clinical studies
Collaborate with functional representatives internally (e.g., Program Physician, Regulatory, Data Management, Medical Writing, Legal, Finance, Quality Assurance, etc.
as well as external vendors to ensure proper conduct and timely completion of all deliverables
Act as the key sponsor representative in interactions with investigational sites, clinical consultants, Contract Research Organizations and other vendors
Coordinate the development of protocols, informed consent forms, case report forms (CRFs), budgets, and study plans related to each study
Provide oversight of service providers and vendors, including development and management of SOPs, Clinical Oversight Plans, documentation, training, co-monitoring, and other activities that lay the foundation of corporate GCP compliance
Collaborate with Data Management to ensure the development of CRFs and related plans for the appropriate management and analysis of the data collected
Assist in the writing of clinical study documents including IND / IDE supporting documents, status reports, and final clinical study reports
BS, BA in Life Sciences or related field
Minimum 5 years clinical experience in a pharmaceutical, biotech, medical device industry, or academia including 3-4 years as a Clinical Research Associate or Clinical Research Coordinator
Capable of working in a fast-paced environment and taking initiative in seeking and utilizing available resources to effectively problem solve, all while ensuring the clinical trial is executed within compliance of regulations and of the highest quality
Proactive in identifying areas of improvement to drive efficiency within Clinical Operations
Knowledge of multiple aspects of the clinical research discipline, GCP, and ICH-E6 is essential
Good interpersonal skills are a requirement
Proficiency in MS Office (Word, Excel, Outlook)
Please send Cover Letter with CV