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Clinical Trial Manager

Employer
Atom Bioscience and Pharmaceutical Co., Ltd.
Location
California (US) - Remote Opportunity
Start date
Jan 18, 2023

The Clinical Trial Manager is accountable for day-to-day oversight of one or more clinical trials including trial start-up, conduct, and close-out activities in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP) and other applicable regulatory requirements. This activity is typically coordinated with one or more CROs. The individual must be a team player and be able to work independently in a fast-paced environment. Strong initiative and follow-through are essential. The ability to maintain confidentiality and operate with the highest ethical standards and professionalism are required.

Essential Duties & Responsibilities

  • Manage operational aspects of clinical trials
  • Participate in protocol, CRF development, Clinical Study Report preparation, NDA submission.
  • Prepare metrics and updates for management.
  • Proactively identify potential study issues/risks and recommend solutions.
  • Participate in CRO/vendor selection process for outsourced activities.
  • Manage CRO interactions, including oversight of activities such as study management, monitoring, site management and project master files.
  • Work with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensure performance expectations are met.
  • Oversee preparation of study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines).
  • Manage clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations.
  • Participate in development, review and implementation of departmental SOPs and processes.
  • Organize and manage internal team meetings, investigator meetings and other trial-specific meetings.
  • Serve as a liaison and resource for investigational sites.
  • Review site study documents (informed consent template and study tools/worksheets), investigator contracts, and site payments.
  • Participate in the selection, training and evaluation of study personnel (contract and internal) to ensure the efficient operation.
  • Perform other duties as assigned.

Core Competencies, Knowledge and Skills

  • Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required.
  • Daily demonstrates a positive, ‘can do’ and service-oriented attitude. Strong oral and written communicator; detail-oriented with a commitment to accuracy.
  • Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks.
  • Ability to multi-task and shift priorities quickly while working under tight deadlines.
  • Skilled in developing collaborative internal and external relationships.

Requirements

  • At least 5+  years of experience in clinical trial operation and a BS or BA in a relevant scientific discipline.
  • Knowledge of FDA and/or EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies.
  • Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and Project

Travel, Physical Demands and Environment

  • Regularly required to operate standard office equipment.
  • Ability to work on a computer for extended periods of time.
  • Regularly required to sit for long periods of time.
  • Regularly required to use hands to operate computer and other office equipment.
  • Close vision required for computer usage.
  • Occasionally required to stoop, kneel, climb and lift up to 20 pounds.
  • Travel possible

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

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