Jobs at IQVIA

Job Overview
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.

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Responsibilities:

• Import data from various sources
• Program quality control checks for source data and reporting data issues
• Interpret project level requirements and develop programming specifications
• Write programming code following established Good Programming Practices
• Program SDTM and ADaM datasets
• Program to create statistical analysis tables, listing and figures
• Validate datasets and all statistical outputs per prescribed gate checks
• Communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and timelines
• Use and promote the use of established standards, SOPs, and standard methodologies
• Export data and clinical study report materials
• Provide training and mentoring to team members and department staff
• You can help us bring clinical trial statistical analysis into the next generation. Award winning and innovative, we will give you access to cutting-edge in-house technology, allowing you to work on global projects across therapeutic areas. Be challenged in a fast-paced team environment that is collaborative in performing biostatistical analyses and advanced statistical programming. Development opportunities and mentoring at all levels enable you to progress your long-term career in the direction you choose.

THE PERSON

• We know that meaningful results require not only the right approach, but also the right people. Candidates should possess a Master’s or Bachelor’s degree in Biostatistics, Statistics, Mathematics, or Computer Science, and have a strong educational or practical evidence in programming.

Key required skills include:

• 3+ experience in Statistical Programmer role from CRO
• Excellent accuracy, attention to detail, problem solving, organizational as well as interpersonal communication.
• In light of the above, candidates for the roles should exhibit the following skills and competencies:
• Experience in programming in SAS within the CRO/Pharma/Biotech/Healthcare industries
• Knowledge of statistics and exhibit routine and occasionally complex analytical skills
• A focus on quality, accuracy, and completeness of work activities 
• Excellent communication skills
• A good understanding of Good Clinical Practice and ICH guidelines
• Ability to independently lead (or have lead potential) and estimate programming scope of work, handle resource assignments, communicate work status, and work within project timelines for deliverables
• Take initiative and can be counted on to get the job done, with integrity
• Have the self-awareness to recognize when negotiating skills and assistance are needed
• Ability to establish and maintain effective working relationships with co-workers, managers, and clients