Consultant Medical Monitor Clinical Development

Company: Clinical Dynamix, Inc.
Location: Austin
Posted on: February 15, 2020

Job Description:

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 StatesJob 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 assignedCollaborates 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 teamsContributes 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 managementReviews and/or assist in the preparation of final clinical study reports (CSRs), or other study documentation (Protocols, ISS/ISEs etc.) as directed by senior managementMaintains 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 meetingsMaintains clinical/therapeutic acumen in medical subspecialty through online and/or in person scholarly programs/lecturesInteracts with staff in other functional areas within the company to ensure the highest level of client satisfaction through successful execution of projectsIdentifies, documents and appropriately resolves out-of-scope work as directed by senior managementAssists in the annual attainment of departmental revenue targets and any other activities as directed by senior managementMaintains working knowledge of Good Clinical Practices (GCPs) and regulatory requirements relating to clinical development and safetyAssures compliance with ethical, legal and regulatory standardsMentors 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 companyDemonstrates competence with the execution of SAE related medical reviewPerform other duties as assigned Job Requirements: Experience / Education:Medical Degree from an accredited medical school required; sub-specialty training highly preferred. Board Certification preferred5 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 developmentMedDRA, 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 EnglishExcellent organizational and time management skillsTravel willingness to travel both domestically (US) and Overseas Knowledge / Skills / Abilities:Proficient in Oral & Written communication skillsProficient in Microsoft (Excel, Word, Outlook) Physical Requirements: Ability to stand /Sit/walk for long periods of timeAbility to Lift 10 lbs occasionallyAbility to crouch, bend, twist, and reach

Keywords: Clinical Dynamix, Inc., Austin , Consultant Medical Monitor Clinical Development, Healthcare , Austin, Texas