Job Opportunities at IQVIA

Data Team Lead, home-based

• You’ll be responsible for managing end-to-end delivery of data management services for multi-service projects, ensuring quality deliverables on time and within budget. You will direct the team in areas of project planning, execution, financial management, communications and milestone deliverables.

Main Responsibilities

• Provide leadership and vision to the team
• Manage and deliver several large scale, high complexity/non-standard aspect studies across a range of sponsors and Therapeutic areas
• Manage sponsors at both Study and Programme Level
• Manage delivery of areas requiring specific expertise (e.g Process, Finance)
• Ensure milestones meet timelines and quality deliverables
• Provide project management expertise working with customer data managers, key decision makers and internal team members to manage continuous process improvements and provide technical expertise
• Ensure open communications with customer and Quintiles management to manage and meet contractual obligations
• Provide input for and perform direct negotiations with customer
• Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders
• Support DM service delivery with comprehensive DM process and technical expertise in executing projects
• Create and/or review and sign-off on all data management plan (DMP) documents
• Track service performance and provide leadership to identify root causes of issues and implement remedial actions
• Serve as the escalation point for unresolved data issues; work with client data managers, vendors, internal team members for resolution
• Maintain internal tracking databases and systems

Minimum Education & Experience

• Bachelor’s Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field
• Around 5 years direct Data Management experience, including 3 or more years as a Clinical Data Management project lead is preferred
• Ability to maintain strong customer relationships

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Responsibilities

• Serve as primary point of contact for customer on data management deliverables
• Manage multiple large studies or program of studies (possibly global)
• Provide leadership and senior support to DTLs on multiple large global programs of global studies
• Provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise
• Lead direct negotiations with customer, e.g., timelines, financial, process, resources
• Meet with Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables
• Independently manage DM service delivery with comprehensive DM process and technical expertise in executing projects
• Serve as the escalation point for unresolved data issues
• Ensure appropriate resources are assigned to meet project deliverables
• Create and/or review and sign-off on all data management plan (DMP) documents
• Manage service performance and provide leadership to identify root causes of issues and implement remedial actions
• Serve as Subject Matter Expert (SME)
• Provide leadership and expertise in a specific CDM task or technology
• Independently manage SOW/budget
• Independently bring process improvements and solutions to the CDM team/CDM department
• Lead a focus team or global or local best practice team
• Provide review and expert opinion in developing, revising, and maintaining core operating procedures and work instructions

Required Knowledge, Skills And Abilities

• Previous experience and proven competence in managing delivery of multiple global trials through full DM life-cycle (i.e. large trials of at least 1000 patients)
• Demonstrated expert data management skills and advanced knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation)
• Previous experience and proven competence in handling complex customer negotiations and bid defense meetings independently
• Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology
• Knowledge of operating procedures and work instructions and the ability to apply them in practice
• Knowledge of Good Clinical Practices and relevant regulatory guidelines
• Excellent communication, interpersonal, customer service, and teamwork skills
• Excellent organizational and problem-solving skills
• Excellent project management skills
• Ability to work independently
• Comprehensive understanding of clinical drug development process
• Ability to establish and maintain effective working relationships with co-workers, managers and customers

Minimum Required Education And Experience

• Bachelor’s Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field
• Around 7 years direct Data Management experience, including 5 or more years as a CDM project lead; or equivalent combination of education, training and experience

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About the role:

• Join our team as the Director of Neurology and play a critical role in shaping the future of healthcare. You will have the opportunity to provide expert medical, clinical, and scientific advice to a variety of Iqvia divisions, actively participate in ground-breaking medical science trials, and serve as a trusted medical expert throughout project delivery. Your therapeutic and medical knowledge will also contribute to the success of our business development efforts. In this role, you'll have a diverse range of responsibilities, including medical monitoring and strategic inputs, with a focus that can evolve as the needs of the company change. This is a unique opportunity to make a real impact and advance your career.

Medical Monitoring:

• Primarily serves as Global Medical Advisor on assigned projects.
• Serves as Scientific Advisor and provides guidance to Project Leaders on the medical and scientific aspects of assigned projects.
• Provides medical support to investigative sites and project staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.
• Performs medical review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs).
• Provides therapeutic area/indication training for the project clinical team.
• Attends and presents at Investigator Meetings.
• Performs review and clarification of trial-related Adverse Events (AEs).
• May perform medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narrative, in collaboration with the Pharmacovigilance department.
• May provide medical support for the Analysis of Similar Events (AOSE), in collaboration with or on behalf of Pharmacovigilance department.
• May perform medical review of adverse event coding.
• Performs review of the Clinical Study Report (CSR) and patient narratives.
• Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
• Available 24 hours per day, 7 days per week to respond to urgent protocol-related issues at the investigative sites.

Medical Strategy:

• Provides expert advice to the development of medically sound delivery strategies for small to large and/or complex multi-region studies in partnership with sales and other functions responsible for business development activities.
• Responsible for the development of the medically related aspects of client proposals including the budget related to medical monitoring.
• Provides medical and scientific advice to key internal stakeholders developing proposals: this may include, but is not limited to, reviewing the protocol for scientific/regulatory soundness and feasibility, identification of target site and principal investigator profiles, anticipated patient recruitment, standard of care and competitive landscape.
• Attends and presents at bid defense meeting, as required.
• Participates in strategic business development activities including presentations to prospective clients.
• Maintains awareness of industry development and may author related publications.
• May serve as Regional/Multiregional/Global Therapeutic Lead for specific indication(s).

Required Knowledge, Skills, And Abilities

• Robust and current knowledge of scientific, clinical, regulatory, commercial, and competitive landscape in the applicable therapeutic area of Neurology.
• Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research.
• Strong communication, presentation, and interpersonal skills, including good command of English language (both written and spoken).
• Ability to establish and maintain effective working relationships with co-workers, managers, and clients.
• Proven skills in providing consultation and advice on multiple assignments are required, as well as initiative and flexibility.

Essential Required Education And Experience

• You must have a Medical Degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education.
• It is essential you have completed Board certification / clinical residency in Neurology.
• You have completed a minimum of 5 years clinical neurology and an additional 4 years or more Clinical Trials experience within a Pharmaceutical or CRO organization