Director of Medical Monitoring & Clinical Science - Work From Home
100 Union St
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Sarah Cannon, is the global cancer institute of Hospital Corporation of America (HCA).
We offers integrated cancer services with convenient access to cutting-edge therapies for those facing cancer in communities across the United States and United Kingdom.
By bringing together a network of renowned cancer experts, we are collaborating and sharing best practices that address every aspect of the cancer journey. Beginning with screening and diagnosis continuing through treatment and survivorship, so that patients can receive quality care with improved outcomes.
Summary of Key Responsibilities: This position will provide medical expertise and direction in global clinical drug development strategy and planning, and in the design, conduct, analysis and reporting of clinical trials managed by Sarah Cannon Development Innovations. Responsibilities including medical input to clinical development plans, protocols, risk management and safety handling plans and other study documentation, evaluation of safety information, data analysis and interpretation, and report writing.
Duties and Responsibilities:
Duties include but are not limited to:
* Medical Director: Development Innovations-Serve as Medical Monitor/study support on a protocol/program basis, as required * Ensure appropriate medical coverage to cover the medical monitoring safety requirements of ongoing trials during all hours of operation * Provide medical and scientific input to the preparation of clinical development plans, protocols, informed consent forms, case report forms, risk management plans, safety handling plans, clinical study reports, manuscripts, and other study documentations and publications, as required * Provide medical and scientific input in the review of clinical data, patient medical safety data and laboratory values * Provide medical and scientific input in the review of data in preparation for Data Safety Monitoring Board meetings, as required and appropriate * Maintain ongoing assessment of all safety profiles and efficacy data for clinical trials managed by Sarah Cannon Development Innovations * Provide medical supervision and training to project teams and study sites * Provide medical monitor training to physician leadership team * Effectively network and collaborate with Sarah Cannon physician leadership and with Sarah Cannon to ensure relevant input to Development Innovations strategic direction and project/program strategies * Respond to Inclusion/Exclusion criteria questions from clinical sites, review violations and track trends, implementing appropriate preventative and/or corrective actions as necessary * Respond to audit report findings in a timely manner * Review study-specific adverse events and safety lab results to identify safety trends * Serve as medical expert in interactions with regulatory authorities and/or Institutional Review Boards/Independent Ethics Committees-Attend conferences, Dose Escalation Meetings, Safety Review Meetings, Data Safety Monitoring Board Meetings, Investigator Meetings, Kick-Off Meetings and Site Initiation Visits, as required * Provide medical and scientific support to RFP proposals to assist in the identification and selection of scientifically robust, practical and fiscally responsible trials and projects, as required * Assist in overseeing quality performance indicators to ensure all research processes work in harmony to accomplish Innovations objectives and goals * Utilize expertise, including knowledge of project and therapeutic advances as well as marketplace developments to participate in internal and external meetings related to review of relevant therapeutic/clinical literature * Maintain thorough and up-to-date working knowledge of GCPs and regulatory requirements relating to clinical development and safety compliance to ethical, legal, regulatory and industry standards * Mentor members of the Innovations team to ensure successful and strategic execution of Innovations projects * Support Innovations Leadership Team in development and execution of strategic growth plan * Maintain clinical/therapeutic acumen in clinical research through education, programs, lectures and publications * Lead the medical monitoring and clinical science teams
* Practices and adheres to the \"Code of Conduct\" philosophy and \"Mission and Value Statement\" * During your employment with Sarah Cannon you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date.
* Broad and in-depth knowledge and cross-functional understanding of drug development and clinical trial methodology; ability to think strategically in relation to clinical development strategy
* Organizational and time management skills * Presentation skills * Computer skills (Word, Excel, Access)
* Effective communicator, with well-developed interpersonal skills * Networking abilities and an ability/willingness to work with individuals across the globe * Ability to inspire, to lead by example and motivate teams to seek solutions and get results * Ability to handle multiple competing priorities effectively
Education: Doctorate Degree
Certification or License:
MD/DO or other advanced healthcare practitioner's degree
* Clinical research or industry experience (5 yrs)
* Track record of successful oversight of large scale, international, multi-center clinical studies