Latest Jobs at IQVIA

Quality Review Specialist

Responsibilities

• Conduct internal Data Management Quality Reviews in order to fulfil business unit, customer and regulatory authority requirements and expectations. Ensure that re-occurring findings/errors are communicated effectively with operational team. Participate in review of corrective/preventative actions. Assure recording of an appropriate response to any non-compliance, with corrective action and a timeframe for completion. Oversee the documentation and reporting quality/compliance issues, relating to the product, process or quality system, to Management within specified regional timelines. Collect and report quality metrics as required to Management. Maintain working knowledge of current applicable regulatory and Sponsor guidelines and related review techniques. Reviews aggregated information provided on the QRP and performs analysis and identification of trends on portfolio level. Reviews the error rate on study level and contact study teams where applicable to discuss CAPA. Liaise with Training Team to update training where needed.

Required Knowledge, Skills And Abilities

• Medical terminology exposure
• Excellent organizational, communication, leadership and computer skills
• Ability to exercise excellent attention to detail
• Ability to act independently and with initiative required to resolving problems
• Ability to establish and maintain effective working relationships with co-workers, managers and clients

Minimum Required Education And Experience

• Bachelor’s degree, or educational equivalence, in clinical, biological or mathematical sciences, or related field, or nursing qualification with 5 years’ experience in clinical trials within a similar function, including proven competence in managing delivery of multiple projects simultaneously through full data management study life-cycle, including large trials >1000 patients; and including experience in handling customer negotiations (e.g. bid defence meetings); 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

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 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way.

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Job Overview

• Acts as a Lead Medical Writer on straightforward projects (e.g. simpler documents under standard timelines). Prepares assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements as well as to the agreed timelines. Negotiates timelines and discusses/resolves customer comments, with senior support as needed.
• Keeps abreast of current medical and/or technical writing/regulatory knowledge, including GCP, along with developments and advances in drug development/medical and/or technical writing.

Essential Functions

• Take a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating and adhering to timelines, organizing document reviews, communicating directly with the customer.
• Manage day-to-day workload: identify project needs, track timelines and implement customer requests, keeping manager/senior staff abreast of progress on tasks and any potential problems with project work.
• Attend project team meetings with or without other writers. Participate in/lead comments resolution or similar meetings with external customers.;
• May give simple presentation to an existing customer (e.g. on processes at a Kick-off meeting).
• Complete project finance activities, including monitoring and forecasting budgeted hours.
• Awareness of budgets and project finance principles, moving towards review and understanding of budgets relating to assigned projects, including out of scope activities.

Qualifications

• Bachelor's Degree Bachelor's Degree in life sciences related discipline or related field (Required); Req
• Master's Degree Master's Degree in life sciences related discipline or related field (Pref); Pref
• Ph.D. Ph.D. in life sciences related discipline or related field (Pref); Pref
• Typically requires 1-3 years of prior relevant experience and related competency levels.
• Familiarity with the structural and content requirements of clinical study reports, protocols, and similar documents.;
• Good understanding of common statistical methods used in clinical trials and/or interpretation of their results.;
• Ability to effectively review a statistical analysis plan and to identify deficiencies, errors, and inconsistencies in statistical output
• Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner.;
• In depth knowledge of drug development, medical writing, and associated regulations. Good understanding of statistical principles and of medical terminology across a range of therapeutic areas.
• Excellent written and oral communication skills including grammatical/technical writing skills.
• Excellent attention to detail and accuracy.
• Communicates clearly, effectively and confidently with others.
• Demonstrated abilities in collaboration with others and independent thought.
• Demonstrates confidence and maturity in most routine medical writing situations.
• Demonstrates good judgement in requesting input from senior staff.
• Ability to establish and maintain effective working relationships with coworkers, managers and customers.
• Ability to effectively manage multiple tasks and projects.
• Must be computer literate.

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 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way.

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Responsibilities

• Serve as Data Team Lead (DTL) on a program of 6-10 global clinical trials or 40+ increasingly complex central laboratory studies
• Provide leadership to CDM team.
• Manage CDM customer relationship for CDM project team to include leading (with minimal guidance) CDM customer negotiations on complex timeline, budgetary and other issues.
• Provide marketing capabilities presentations and business development presentations.
• Serve as Data Operations Coordinator (DOC) for one or three global clinical trials with fewer than 25 operations staff (excludes DE) or 20-40 central laboratory studies, or serve in a leadership role to a specific DM Task.
• Serve as back-up for Data Operations Coordinator or Data Team Lead
• Provide leadership to Operations team
• Provide technical expertise
• Serve as a Subject Matter Expert (SME)
• Provide leadership and expertise in a specific CDM task or technology
• Manage delivery of projects through full data management process life-cycle.
• Management of Project timelines, Quality issues, Resource management and SOW (scope of work) / budget.
• Provide justification for customer negotiations.
• May serve as Project Manager for single service data management projects.
• Manage comprehensive data management tasks pertaining to the documented project specifications.
• Manage comprehensive quality control procedures.
• Provide data management expertise and data management process improvement to CDM management.
• Mentor other team members in training and developing data management expertise.
• Independently bring project solutions to the CDM team and the CDM Department.
• Manage a focus team or a best practice team
• Manage the development and implementation of new technology/tool.
• Present at professional conferences and/or publish articles in professional journals.
• Provide CDM with technical expertise.
• Provide review and expert opinion in developing, revising, and maintaining core operating procedures and working instructions.
• Perform other duties as directed by the functional manager.
• Meet objectives as assigned.
• Develop and maintain good communications and working relationships with CDM and project teams.

Required Knowledge, Skills And Abilities

• Thorough knowledge of the data management process and experience in specialized data management skills (e.g., therapeutic, extensive knowledge, SAE reconciliation, central laboratory, and/or new technology
• Knowledge of operating procedures and work instructions and the ability to apply them in practice
• Excellent experience and organizational, communication, and demonstrated expert data management skills
• Comprehensive understanding of clinical drug development process (detail oriented)
• Ability to establish and maintain effective working relationships with co-workers, managers and clients

Minimum Required Education And Experience

• Bachelor’s degree, or educational equivalence, in clinical, biological or mathematical sciences, or related field, or nursing qualification with 5 years’ experience in clinical trials within a similar function, including proven competence in managing delivery of multiple projects simultaneously through full data management study life-cycle, including large trials >1000 patients; and including experience in handling customer negotiations (e.g. bid defence meetings); or equivalent combination of education, training and experience

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 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way.