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Clinical Operations Strategist - IQVIA Biotech

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Primary Location: Wilmington, North Carolina, United States Additonal Locations: Alpharetta, GA,USA; Austin, TX,USA; Bloomington, IL,USA; Boston, MA,USA; Cambridge, MA,USA; Chicago, IL,USA; Columbus, OH,USA; New York, NY,USA; Plymouth Meeting, PA,USA; Raleigh, NC,USA Full time R1233327

Job description

IQVIA Biotech is seeking a Clinical Operations Strategist to develop clinical strategy for clinical studies then develop study budgets based on that strategy (Home Based):

BASIC FUNCTIONS:

This role will drive the clinical monitoring strategy and budget development lifecycle from customer identification through budget preparation and submission, through the bid defense process to post-decision review and transition to operational teams.  A key success factor will be the creation of effective clinical strategies, accurate budgets and appropriately resourced opportunities that meet the product development needs of IQVIA Biotech clients and the assurance that proposals are aligned with global IQVIA Biotech clinical operations strategy and corporate goals.    

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

  • Represent IQIVA Biotech Clinical Operations on the cross-functional Core Proposal Team in response to Requests for Proposal (RFPs) that include clinical services across all regions
  • Serve as the lead for the development of clinical strategy, study budgets and proposal documents for client submission and review
  • Participate in all required Core Proposal Team meetings and strategic, and tactical, discussions regarding assigned Requests for Proposal  in order to gather and identify the required information needed to build proposal strategy and budgets
  • Assess and mitigate operational risks through the protocol-specific development of sound clinical strategy
  • Collaborate with the cross-functional Core Proposal Team to ensure sound clinical operational strategy, related budgeted tasks and clinical operational costs are appropriate and that they maximize the potential to win the opportunity
  • Collaborate with global IQVIA Biotech clinical operations management to identify operational parameters, requirements, tools, technology and innovative ideas that may be included in proposed clinical strategy
  • Collaborate with global IQVIA Biotech clinical resourcing delegates to assign appropriate staff for proposals and bid defense meetings
  • Complete required proposal deliverables by established deadlines for client submission; such deliverables may include, but not be limited to, clinical input (text) for Requests for Information (RFI), clinical budgets developed in relevant IQVIA Biotech budgeting tools, clinical input (text) for Proposals, Curricula Vitae and biographies for proposed clinical personnel, responses to Client inquiries and questions as a result of submitted deliverables  
  • Proactively and objectively advise the global IQVIA Biotech Senior Management Team during the pre-submission process, and during the post-submission period
  • Participate in the planning and preparation of materials for presentations regarding clinical operations, and effectively deliver presentations to internal and external customers
  • Develop and maintain effective relationships with key stakeholders across multiple functions within IQVIA Biotech, IQVIA and its affiliates
  • Plan, prepare and participate in bid defense meetings (BDMs) as required, including counseling and supporting assigned clinical personnel for successful delivery and presentation during BDMs
  • Work with and prepare clinical team as needed for bid preparation as well as understand the scope of work
  • Participate in post-award activities as needed, including, but not limited to, study transition meetings from the Core Proposal Team to operational teams 
  • Other duties as assigned

KNOWLEDGE, SKILLS AND ABILITIES:

  • Thorough knowledge of Clinical Trials
  • Sound understanding of the IQVIA Biotech proposal process
  • Solid understanding of IQIVA Biotech Clinical Operations working practices and processes
  • Ability to manage multiple, competing priorities with a high degree of accuracy
  • Excellent communications skills (verbal and written)
  • Ability to negotiate effectively
  • Strong organizational skills
  • Ability to work flexible hours
  • Ability to effectively interact with colleagues at all levels of the organization
  • Willingness and ability to travel (domestically and internationally) as required

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

  • Very little physical effort required to perform normal job duties (unless otherwise indicated)

MINIMUM RECRUITMENT STANDARDS:

  • Bachelor’s Degree (in US) or equivalent
  • 3-5 years of direct experience in clinical trials and 3 years within a CRO setting, or equivalent level of education, training and experience; knowledge of the budget/proposal development process is a plus
  • Demonstrated ability to work effectively at all levels of an organization
  • Excellent written and verbal communication skills
  • Ability to work independently and in a team environment
  • Ability to prioritize work and manage competing deliverables  
  • Ability to maintain confidentiality with sensitive materials
  • Strong Microsoft Excel knowledge and working knowledge of Microsoft Word

CLASSIFICATION (US): 

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

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

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.

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