Director, Medical Research (Phase 1 Clinic located in Overland Park, KS) (Part-time) - (R1016529) in Overland Park, KS at IQVIA™

Date Posted: 8/8/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Experience:
    At least 8 year(s)
  • Date Posted:
    8/8/2018
  • Job ID:
    R1016529

Job Description

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

Description

PURPOSE


In this part-time (30 hours or less) role you will serve as a Principal investigator during the clinical part of the early phase performed at the unit. Ensure the medical safety and well-being of patients/volunteers during trials. Oversee network studies in terms of protocol review and support with strategy and client interaction.
 
RESPONSIBILITIES

  • •Ensure clinical studies are performed to acceptable medical standards, on time, and meet the requirements of the client, ICH, GCP and other guidelines and regulations as appropriate.
  • •Provide medical supervision to Nurse Practitioners, in regards to protocol related issues and medical oversight.
  • •Provide medical support to project staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.
  • •Review and clarification of trial-related Adverse Events (AEs) and Serious Adverse Events (SAEs).
  • •Perform medical review of Adverse Event coding. the protocol, Investigative Drug Brochure (IDB), and where appropriate,
  • Case Report Forms (CRFs).
  • •Review Clinical Study Report (CSR) and patient narratives, where applicable.
  • •Communicate appropriately and in a timely manner with clients on all medical and clinical aspects of studies
  • •Provide medical supervision of all clinical procedures to ensure the physical well-being of the study subjects at all times.
  • •Provide therapeutic area/indication training for the project clinical team, where applicable.
  • •Liaison with the Phase 1 Global Safety review committee for first-in-human studies as per IQVIA procedures.
  • •Attend study initiation meetings, weekly team meetings, and client meetings, as needed or requested.
  • •Serve as Medical/Scientific Advisor and provide guidance to Project Managers on the medical and scientific aspects of assigned projects.
  • •Provide support to the proposal development team which may include, but is not limited to, reviewing the protocol for feasibility, giving guidance as to anticipated enrollment, and general advice as to the various risks associated with running a particular study.
  • •Serve as a resource, and may participate in strategic business development activities including presentations to prospective clients, professional meetings, and other business development activities for Medical & Scientific Services.
  • •Screen volunteers for studies and consider the inclusion and exclusion criteria vs the medical hazards for each volunteer by reviewing the medical history and the laboratory results. Perform an adequate physical examination.
  • •Inform volunteers on the purpose of the study and their rights according to the principles of ICH-GCP and the Helsinki declaration. Obtain written informed consent according to GCP.
  • •Maintain, in conjunction with Phase I Quality Assurance, the necessary quality standards related to IQVIA requirements, SOP’s policies and guidelines.
  • •Attend the scientific parts of meetings when clients presenting and proposing forthcoming studies.
  • •Develop and maintain professional relations with local Opinion Leaders and primary care physicians to ensure their high regard for IQVIA and the science and ethical standards of the studies conducted.
All responsibilities are essential job functions unless noted as nonessential (N).

Job Requirements

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • •In-depth knowledge of GCP/ICH and applicable regulatory guidelines
  • •In-depth knowledge of drug development process
  • •Excellent presentation skills
  • •Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
  • •Strong written and verbal communication skills including good command of the English language
  • •Excellent organizational and problem solving skills
  • •Effective time management skills
  • •Ability to manage competing priorities
  • •Ability to establish and maintain effective working relationships with coworkers, managers and clients

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • •A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education, and a medical license from the country or region in which he/she resides and works is required, with 8 years experience in clinical medicine including 5 years previous experience in clinical research role; or equivalent combination of education, training and experience

PHYSICAL REQUIREMENTS

  • •Extensive use of telephone and face-to-face communication requiring accurate perception of speech
  • •Extensive use of keyboard requiring repetitive motion of fingers
  • •Regular sitting for extended periods of time
  • •Occasional travel




EEO Minorities/Females/Protected Veterans/Disabled

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.

Whatever your career goals, we are here to ensure you get there!

We invite you to join IQVIA™.


Job ID: R1016529