Strategic Feasibility Manager (Home/Office-Based) - IQVIA Biotech (R1032535) in Morrisville, NC at IQVIA™

发布日期: 10/5/2019

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  • 员工类型:
    Full-Time
  • 经验:
    Not Specified
  • 发布日期:
    10/5/2019
  • Job ID:
    R1032535

职位描述

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.

IQVIA Biotech is seeking a Strategic Feasibility Manager to support our growing team. Prior experience in Strategic Feasibility & Clinical Planning is required. Prior line management experience is a plus.

BASIC FUNCTIONS:

The Strategic Feasibility Manager is responsible for coordinating and managing all of the efforts necessary for producing feasibility proposals and reports.  In this capacity this individual is responsible for assuring the Feasibility  Department elicits input from and coordinates activities with all of the stake holders in the feasibility process including: Proposals, Study Start-Up/& Site Services, Regulatory, Medical Affairs, Project Management and Clinical Operations and combining resulting information with IQVIA Biotech’s corporate experience to produce recommendations for country and site strategies.   The Manager of Feasibility assures the assembly, editing, and review of feasibility proposals and reports, (feasibility proposals are documents that detail the strategy, actions, and the cost of conducting feasibility, while feasibility reports are documents that describe the outcomes of feasibility projects).  The Feasibility Manager may also participate in internal and external briefings and presentations of feasibility, when deemed necessary.  This position reports directly to the VP of Operations (Study Start Up/Site Services & Functional Outsourcing) in setting priorities for workload and deliverables.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

  • Directs the activities of the Feasibility Department which includes:
    • Identifying  and present regions where the disease is prominent to create an initial country pool to be further refined based on corporate experience, operational capabilities, medical input, and other feasibility considerations
    • Identifying barriers to enrollment in the form of competing clinical trials.  Accessing open source and proprietary databases to determine similar patient populations and or therapeutic classes of drugs being studied.  Determine whether the countries proposed have comparator drug access/reimbursement. As appropriate prepare tabular displays of this information for evaluation by the feasibility stake holder pool.
    • Representing IQVIA Biotech’s global or regional expertise by presenting our clinical trial footprint in the indication which may include compiling corporate experience and expertise in specific indication when needed.
    • Working with IQVIA Biotech medical experts on the conduct of the trial as well as its acceptance and standard of care in target regions.  Incorporate medical review of the protocol and challenges to enrollment and the retention of subjects. 
    • Collaborating with IQVIA Biotech Regulatory Affairs determine timelines associated with the conduct of the proposed trial.
    • Work with Study Start Up/Site Services to determine costing of conducting a questionnaire process with potential sites if appropriate.
    • Provides overall recommendations on the countries, number of sites and projected number of patients resulting from collaborative discussions noted above designed to meet or exceed client stated goals. 
    • This function also identifies alternatives to client initial recommendations resulting from information gathered.
  • Develops increased capacity within the Feasibility Department to assure ability to meet overall Corporate Business Development Goals.
  • Develops project timelines and sets strategic goals for department and internal staff.
  • Provides guidance as needed for completion of tasks.  Assesses performance and recommends salary adjustments as the department expands to include other team members.
  • Designs, develops, and updates Standard Operating Procedures for all Feasibility functions.
  • Develops budgets and is accountable for maintaining department activities within approved financial  guidelines
  • Assures that Feasibility function interfaces effectively with all other key operating departments within IQVIA Biotech.      
  • Works with Human Resources in recruiting and hiring qualified Feasibility staff for effective Department functions.
  • Ensures training for the Feasibility staff.  Selects training curriculum for the staff.
  • Reviews and approves reports and manuscripts, as necessary.
  • Maintains current knowledge of regulations, and guidelines appropriate for functioning in this capacity.
  • Participates in business development activities as requested to grow IQVIA Biotech business.

KNOWLEDGE, SKILLS AND ABILITIES:

  • Demonstrated knowledge of government/international databases, open source databases or more proprietary databases (e.g., PubMed/Medline, ClinicalTrials.gov, Citeline).
  • Demonstrated ability to form strong working relationships with other groups within the organization essential to high level performance in this position.
  • Demonstrated knowledge of quality assurance related to the Feasibility process and willingness to promote the quality process within the group.
  • Ability to motivate, lead, and grow a team.
  • Experience with pharmaceutical product development.
  • Knowledge of FDA and/or ICH guidelines for conducting clinical research.
  • Excellent written and verbal communication skills.
  • Exceptional ability to conceptualize, develop and manage timelines.
  • Demonstrated knowledge of resources required to permit development of or reporting on results of the feasibility process.
  • Considerable ability to develop and maintain productive relationships with colleagues and other research organizations.

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

  • Very limited physical effort required to perform normal job duties
  • Ability to travel domestically and internationally as requested.

MINIMUM RECRUITMENT STANDARDS:

  • BS in a health-related field with at least five years of demonstrated clinical research experience; or appropriate BA/BS Degree in life sciences (i.e., nursing, pharmacy, pre-medicine, etc.) or appropriate degree post-doctoral studies.  Within the total years of experience, at least one (1) year must be in a contract clinical research organization. 
  • Pharmaceutical/clinical research experience and demonstrated extensive electronic research and manuscript preparation is required. 
  • Demonstrated expertise in the research and preparation of feasibility proposals.
  •  Excellent written and verbal communication skills , with superior ability to present data in a clear and concise format through preparation of tables and graphic representations that lead to the ability to  understand the data being presented, is a requirement.

CLASSIFICATION:

This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.

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™

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.



Job ID: R1032535