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Consultant Medical Monitor Clinical Development
Clinical Dynamix, Inc.
Job Location: Austin, TX
Global Clinical Research Organization is looking to hire a Medical Monitor for their Oncology Immunology trials * must have oncology experience, and should be recent (within the past 5 years), and must have immuno-oncology experience of some type (cell therapy, checkpoint inhibitors, etc.). Can be remote from any city in United States

Job Summary: The Medical Monitor, Oncology provides medical management and professional medical support for clinical research projects as the assigned Global Oncology Medical Monitor. Assists in activities requiring Medical and Scientific support, including but not limited to: Assistance with feasibility assessments, medical training, provision of medical/clinical input to the design of study protocols and clinical development programs. Assistance with business development activities, as directed by the department head.

Essential Job Functions:

Tasks may include but are not limited to:

  • Serves as Global Lead Medical Monitor for regional and/or global Oncology clinical trials to which s/he is assigned
  • Collaborates with the other members of the Medical and Safety project team to process Serious Adverse Events (SAEs)
  • Provides therapeutic and protocol-specific training to the project teams
  • Contributes medical input into the design of Oncology clinical development programs, study protocols, research papers, client focused white papers, etc.
  • Independently supports Business Development through participation in proposal generation, feasibility assessments, review of proposals/contracts for medical services, and attendance at meetings with sponsors as directed by department senior management
  • Reviews and/or assist in the preparation of final clinical study reports (CSRs), or other study documentation (Protocols, ISS/ISEs etc.) as directed by senior management
  • Maintains a high level of competence with assigned projects, including knowledge of project and therapeutic advances as well as marketplace developments by participating in internal meetings (company-wide project tracking, medical management meeting, etc.) review of relevant therapeutic/clinical literature and attendance at conferences and meetings
  • Maintains clinical/therapeutic acumen in medical subspecialty through online and/or in person scholarly programs/lectures
  • Interacts with staff in other functional areas within the company to ensure the highest level of client satisfaction through successful execution of projects
  • Identifies, documents and appropriately resolves out-of-scope work as directed by senior management
  • Assists in the annual attainment of departmental revenue targets and any other activities as directed by senior management
  • Maintains working knowledge of Good Clinical Practices (GCPs) and regulatory requirements relating to clinical development and safety
  • Assures compliance with ethical, legal and regulatory standards
  • Mentors other medical staff as directed by Senior management and by consistently displaying exemplary work ethics, compassion and integrity, support Senior Managements leadership of both the department and the company
  • Demonstrates competence with the execution of SAE related medical review
  • Perform other duties as assigned

Job Requirements:

Experience / Education:

  • Medical Degree from an accredited medical school required; sub-specialty training highly preferred. Board Certification preferred
  • 5 years experience in the pharma/biotech/CRO industry as a medical monitor or study physician overseeing Oncology clinical trials; or 3 years pharma/biotech/CRO industry experience plus 5+ years academic experience in oncology clinical research and drug development
  • MedDRA, ICH and GCP knowledge required. Solid knowledge of FDA regulatory guidelines, and knowledge of international regulatory guidelines highly desired (EMA, etc.)
  • Solid computer skills (Word, Excel)
  • Excellent communication and presentation skills including strong fluency in spoken and written English
  • Excellent organizational and time management skills
  • Travel willingness to travel both domestically (US) and Overseas

Knowledge / Skills / Abilities:

  • Proficient in Oral & Written communication skills
  • Proficient in Microsoft (Excel, Word, Outlook)

Physical Requirements:

  • Ability to stand /Sit/walk for long periods of time
  • Ability to Lift 10 lbs occasionally
  • Ability to crouch, bend, twist, and reach

How To Apply:
You will be directed to another website for application instructions.
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