Jobs at IQVIA

•  Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Qualifications

• Bachelor's Degree Degree in scientific discipline or health care preferred. Req
• Requires at least 2 years of year of on-site monitoring experience.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
• i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

go to method of application »

Job Overview:

• As a Statistical Programming Scientist/Principal, you will be given access to cutting-edge, in-house technology and opportunities to work on global projects across a variety of therapeutic areas.
• Thanks to our development opportunities and mentoring at all levels, you will be able to progress your long-term career in the direction you choose.
• You will also provide advanced technical expertise to develop process methodology for the department to meet internal and external clients’ needs, across complex projects and studies.
• This involves planning and coordinating the development of integrated programming solutions, serving the full spectrum of statistical programming needs.
• You will provide internal consulting services, including specifications and user needs analysis for complex project or client requirements.

Requirements:

• Bachelors or Masters’ in Computer Science, Mathematics or equivalent
• 7+ years’ Statistical Programming experience within the Life-Science Industry
• Advanced knowledge of statistics, programming and/or clinical drug development process
• Advanced knowledge of computing applications such as Base SAS, SAS Graph and SAS Macro language
• Advanced knowledge of relevant Data Standards (such as CDISC/ADaM/SDTM)
• From camaraderie to professional development, working at IQVIA provides unique opportunities to advance your career alongside a group of diverse and talented colleagues.

What is in it for you?

• Global exposure
• Variety of therapeutic areas
• Collaborative and supportive team environment
• Access to cutting-edge in-house technology
• Excellent career development and progression opportunities
• Work-Life Balance