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    Associate Medical Director/Principal Investigator(Anesthesiologist)

    Thermo Fisher Scientific
    5+ years
    Not Disclosed
    Remote, USA
    10 July 29, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Thermo Fisher Scientific: Advancing Science for a Healthier, Cleaner, and Safer World

    At Thermo Fisher Scientific, we are dedicated to making a positive global impact through our mission of enabling our customers to create a healthier, cleaner, and safer world. Our teams are equipped with the resources necessary to achieve personal career goals while advancing science beyond conventional boundaries. With clinical trials conducted in over 100 countries and a commitment to innovative clinical research frameworks, our work spans laboratory, digital, and decentralized clinical trial services. Your commitment to quality and accuracy is essential in improving health outcomes for people and communities worldwide.

    Location/Division Information

    Our Early Development team focuses on Phase I and IB trials, representing the first practical tests of a compound’s clinical relevance and commercial potential. These trials are the culmination of extensive research and set the foundation for subsequent studies to determine the efficacy, safety, and positive impact of our compounds on patients' lives.

    Position: Associate Medical Director

    Key Responsibilities

    • Conduct clinical trials according to ICH GCP, local regulations, study protocols, and company processes, ensuring participant safety and well-being.
    • Oversee clinical evaluation and assessment of participants to confirm eligibility for study enrollment.
    • Monitor enrollment progress, pre-screening and screening success rates, screen failure rates, safety, and retention of participants.
    • Interpret protocols and Investigator’s Brochures (IB) and participate in patient recruitment strategy initiatives.
    • Prioritize the ethical conduct of studies, maintaining the highest standards of participant welfare.
    • Fulfill medical duties per protocol, SOP/COP, ICH, GCP, and local regulations.
    • Address and report any safety concerns impacting stakeholders or participants, and handle complaints or Quality Incidents (QIs) as per site processes.
    • Ensure meticulous attention to detail in recording information and source data management.
    • Participate in audit preparations and site inspections, overseeing the management of investigational medical products (IMP).

    Qualifications and Experience

    • A valid medical degree (M.D. or D.O.) with a medical license in good standing and unrestricted ability to practice. Texas State licensure will be required.
    • Board Certification in a relevant field, preferably Anesthesiology, or consideration for Emergency Medicine physicians.
    • A valid ICH GCP certificate (to be obtained upon employment).
    • Previous experience in clinical research is preferred but not required.
    • Proficiency in general medical diagnosis and treatment.

    Skills and Abilities

    • Strong understanding of medical terminology, drug safety, and lab report interpretation.
    • Proficient in Microsoft Office and other sponsor-related programs and portals.
    • Excellent administrative skills with a passion for quality and attention to detail.
    • Ability to work well under pressure and meet deadlines.
    • Understanding of commercial and financial concepts and their impact on the business.
    • Ability to work independently, prioritize tasks, and multitask effectively.
    • Strong cognitive skills for critical thinking, learning, reasoning, and detailed attention in daily operations.
    • Ability to communicate effectively and work collaboratively with diverse groups.

    Physical Requirements and Work Environment

    • Work is primarily performed in an office environment with exposure to standard office equipment.
    • Occasional local and international travel may be required.
    • Frequent stationary work for 6-8 hours per day, with repetitive hand movements.
    • Occasional physical activities such as crouching, stooping, bending, and light to moderate lifting.
    • Ability to use various computer software and communicate information effectively.
    • Regular interaction with others, often requiring periods of intense concentration.
    • Ability to perform under stress and manage multiple tasks with minimal guidance.
    • Consistent attendance is essential.

    Benefits

    Thermo Fisher Scientific offers competitive remuneration, annual incentive plan bonuses, healthcare, and a comprehensive range of employee benefits. We provide an innovative and dynamic work environment that promotes integrity, intensity, involvement, and innovation. Our culture encourages personal and professional growth, offering exciting career and development prospects.

    For more information, please visit our benefits page at Thermo Fisher Scientific Benefits.

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