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Associate Clinical Trial Scientist

Company: Bayer AG
Location: Whippany
Posted on: April 10, 2021

Job Description:

Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change. The primary responsibilities of this role, Associate Clinical Trial Scientist , are to:

  • Prepare the Medical Review Plan (MRP) with input and review by relevant stakeholders, as appropriate [Clinical Development Leaders (CDL), CPM, StM, DM];
  • Understand the asset's biological mechanism, clinical strategy, scientific interpretation of disease and target-based literature;
  • Facilitate the development of a study-specific Table of Contents (TOC) if needed, including core TFLs and compound-specific TFLs in collaboration with the study team, StM/DM/Stats and CDLs;
  • Review Safety TFLs at a frequency as specified in the Material requirements planning (MRP);
  • Review and analyze safety data to establish the presence or absence of trends and follow-up as appropriate;
  • Develop a Safety Slide Deck (SSD) periodically for cross functional review with specific attention to e.g. Adverse Events [Treatment-Emergent Adverse Events (TEAE), Related TEAE)], Treatment- Emergent Serious Adverse Events (TESAE), Adverse Events of Special Interest (AESI), worst Post-Baseline Laboratory Shift Tables, Study Status, Summary Table, AE Summary, SAE Summary;
  • Query identifiable safety-related medical discrepancies or requests for clarification in the appropriate EDC and related systems;
  • Review patient-specific and overall safety data presented in the clinical study report (CSR);
  • Participate in eCRF development and User Acceptance Testing (UAT);
  • Support medical protocol deviations cross-functional review;
  • Collaborate effectively with study team on study deliverables;
  • Contribute to projects and initiatives aimed at improving processes and services;
  • Be the point of contact and responsibility for the safety aspects of the study to ensure the participant's safety and data integrity, supporting Bayer sponsored clinical development trials within the Oncology SBU. WHO YOU ARE Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following: Required Qualifications:
    • Bachelor's--degree or equivalent;
    • Robust knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution;
    • Broad understanding of the pharmaceutical industry and the clinical development process;
    • Excellent oral and written communication, computer/database management skills;
    • Ability to establish and build relationships at all levels in a highly dynamic and matrixed environment;
    • Ability to work under pressure in aggressive timelines including as a part of a cross-functional team;
    • Fluent English (both written and spoken). Preferred Qualifications:
      • Advanced degree;
      • At least three years of industry clinical development experience with experience in Oncology, Immunology and/or biomarker-driven trials. Your application Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. To all recruitment agencies: Bayer does not accept unsolicited third party resumes. Bayer is an Equal Opportunity Employer/Disabled/Veterans

        Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below. Country: United States
        State: New Jersey
        Location: Whippany
        Reference Code: 377201
        Functional Area: Computational Science, Data Science & Statistics
        Entry Level : Professional
        Email hrop_usa@bayer.com Share
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        • E-Mail Apply Online At Bayer, we believe our differences drive innovative solutions. Building a sustainable culture of inclusion --and a diverse workforce are essential to our success. Our unique identities and experiences empower us to achieve our inclusive vision of Health for All, Hunger for None. Bayer has heard reports of fraudulent recruiting activities. If you are the target of what you believe to be fraudulent recruiting activity please get in touch with us.

Keywords: Bayer AG, New York , Associate Clinical Trial Scientist, Healthcare , Whippany, New York

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