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Senior Clinical Trials Manager
Apex Systems, Inc.
Seattle , WA 98101
Posted 4 months ago
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Description Apex Life Sciences is looking for an Sr. CTM to serve a commercial stage bio-pharmaceutical company in Seattle!
The ideal candidate MUST have 8+ years of sponsor experience. This is a Full-Time, Permanent opportunity. For immediate consideration, please send resumes to:
Position Summary: The Sr. Clinical Trials Manager (CTM) works closely with various internal team members and vendors as well as clinical study sites to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals, and budgets.
This person may have line management responsibilities. This person is able and willing to perform all duties or functions of subordinates. Essential
Duties & Responsibilities:
Manages the operational aspects of clinical trials Manages Clinical Operations personnel Manages the study project plan, including timeline, budget, and resources Participates in protocol, CRF and strategy development, Clinical Study Report preparation, NDA submission, as appropriate Prepares metrics and updates for management, as assigned Proactively identifies potential study issues/risks and recommends/implements solutions Participates in and facilitates CRO/vendor selection process for outsourced activities Manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project master files) Works with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensures that performance expectations are met Prepares and/or reviews/approves study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines) Manages clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations Participates in the development, review and implementation of departmental SOPs and processes Recommends and implements innovative process ideas to positively impact clinical trials management Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings Serves as a liaison and resource for investigational sites Reviews site study documents (informed consent template and study tools/worksheets), investigator contracts, and site payments Participates in the selection, training and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function Performs some or all of the Duties and Responsibilities outlined for Senior Clinical Research Associate, as needed Experience and Education Required: A 4-year degree from a university with a related degree in a Life Science 8+ years of related clinical trial management experience with a minimum of 2 years of supervisory experience Experience in interactions with outside vendors, e.g., CROs and other vendors Familiar with advanced concepts of clinical research and able to work effectively in a team/matrix environment Knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines Able to deal with time demands, incomplete information or unexpected events Able to provide clinical operations expertise to clinical development in a specified product areas and projects Able to travel approximately 10% overnight (50% or greater during peak times) Behavioral Competencies Required: