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Senior Clinical Trial Manager

Company: Incyte Corporation
Location: Wilmington
Posted on: February 25, 2021

Job Description:

The Drive to Discover. The Experience to Deliver. Looking for a challenge and a chance to grow your career? Then Incyte is the pharmaceutical company for you. While our pipeline demonstrates the ability to compete with much larger pharmaceutical companies in selecting compelling targets and creating high-quality drug candidates, our smaller size enables employees to see the direct impact of their contributions on the direction of the company.--Due to our smart, agile culture and cutting-edge science, we--delivered a novel, first-to-market product in an unmet medical need in 2011 - the first in the company's history. Opportunities for taking on new and/or additional responsibilities, in addition to advancement, are a key element in our culture. Add to that a science-based, fast-paced work environment and you've got an exciting company in which to work. In addition to opportunities for growth, we offer an outstanding--benefits --andcompensation --package to help meet personal needs as well. Incyte Corporation values the talents of our diverse workforce and is proud to be an Equal Opportunity Employer. Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.-- The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules. Job Summary (Primary function)
The Senior Clinical Trial Manager provides input to the overall operational trial(s) implementation, manages trial(s) timelines, budget, feasibility, country identification and sites selection, enhanced patient recruitment, functions as the primary liaison for internal stakeholders and vendors leads multidisciplinary departments initiatives, and provides support for process changes to increase efficiency in study executions. Essential Functions of the Job (Key responsibilities)

  • Ensure adherence to Good Clinical Practice and all applicable local and international regulations.
  • Accountable to deliver Trial(s) on time, within budget, and with highest achievable quality.
  • Mange the conduct of clinical Trial(s) and provide operational leadership within an outsourced, CRO model.
  • Assist in the review, development and/or writing of clinical trial documents and manuals, including but not limited to Protocol, Case Report Forms, informed consent forms, Clinical Study Report and other regulatory documents.
  • Manage the evaluation and selection of investigative sites.
  • Select, coordinate and monitor activities of CRO and associated vendors.--
  • Review of monitoring reports and conduct co-monitoring visits, as needed.
  • Develop and manage trial(s) timelines, budget and project milestones.
  • Participate in data management activities, including data review and discrepancy resolution.
  • Ensure set up and maintain all systems that implement trial(s) and track progress throughout the duration of the program.--
  • Generate necessary reports to update leadership on conduct of trial.
  • Ensure appropriate clinical trial supplies are ordered in time and supply plans are implemented and managed.
  • Develop recruitment plans, risk-mitigation plan, monitor, and implement contingencies as required.
  • Participate in monitoring study safety.--
  • Develop key study quality metrics (e.g., protocol deviations per site; number of queries per site, number of SOP deviation for the study, number of data base migrations etc) and determine appropriate action in conjunction with study team.--
  • Perform initial review of CRO and other third party study vendor invoices to ensure that work is performed in accordance with scope of work.
  • Assist the Clinical Scientist, Medical Monitor, CRA and other third party vendor training on protocols and practices.
  • Lead the multi-disciplinary teams in operational study team meetings.
  • Function as the primary contact for trial(s) between Drug Development and other departments.
  • Assume responsibility to participate as a member of working groups and perform special projects, as assigned, to improve the efficiency, effective and quality of the functioning of the Development Operations Department.
    Qualifications (Minimal acceptable level of education, work experience, and competency)
    • BS/BA degree or a relevant degree with strong emphasis on science.
    • Minimum of five years of experience in the biopharmaceutical industry or other relevant clinical research experience in the conduct and management of multinational clinical trials.
    • Able to manage complex and/or large trials.
    • Demonstrated ability to manage complex and/or large trials in an outsourced, CRO model a plus.
    • Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience.
    • Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously.
    • Demonstrate leadership, critical thinking, time management and problem solving skills.
    • Experience in executing a wide range of clinical trial activities (from initiation to clinical study report).
    • Used to work in a multidisciplinary setting, strong cooperative team player, ability to be flexible and adapt to a changing environment.
    • Good planning, prioritization, problem solving and organizational skills; strong customer-orientation, used to work independently.
    • Strong communication skills, used to communicate with a broad range of stakeholders and to build strong positive relationships.
      Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer. The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.

      During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here . You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.-- You can learn more about Incyte's data protection practices here . By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable). Please contact if you have any questions or concerns or would like to exercise your rights.

Keywords: Incyte Corporation, Boston , Senior Clinical Trial Manager, Executive , Wilmington, Massachusetts

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