Vacant Jobs at IQVIA

Job Description

Job Overview

• Primarily acts as back-up Medical Advisor but may serve as Regional Medical Advisor on 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.

Essential Functions

• Primarily acts as back-up Medical Advisor but may serve as Regional Medical Advisor on 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.
• May contribute to the medical review of the protocol, Investigative Drug Brochure (IDB) and/or Case Report Forms (CRFs).
• May provide therapeutic area/indication training for the project clinical team.
• Attends and may present 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 24/7 to respond urgent protocol -related questions from investigative sites, in accordance with local labor laws.

Qualifications

• Medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education.
• Board Certified.
• Typically requires 3 - 5 years of prior relevant experience in general clinical medicine including experience in the requested applicable medical specialty area or equivalent combination of education, training, and experience.
• Current knowledge of medical, scientific, and clinical landscape in applicable therapeutic area.
• Good 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.
• Attention to details, flexibility, and ability to provide advice on multiple assignments.
• Current or prior license to practice medicine.
• Clinical experience in the requested medical specialty.

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Job Description

PURPOSE

• Serve as the EDC System Designer for the build team, and produce accurate and complete specifications documents.

RESPONSIBILITIES

• Development of eCRF to meet the needs of the customer and the clinical trial utilizing protocol and specifications provided at the pre-design meeting. Understand Quintiles EDC processes and the requirements on the design for reporting and study management. 
• Advise and provide justification for design decisions to Principal Programmer and at Design Meeting. 
• Responsible for optimal design reducing the number of edit checks required, ensuring good system performance, and the utilization of global/client specific libraries to ensure consistency and efficiency. 
• This role will eventually (3-6 months after starting) be responsible for providing a draft Edit Check Specification to the DTL. 
• Requires good communication skills and this role will work closely with the Study DTL and Principal Programmer. 
• Requires a technically logical thinker to resolve questions and issues with the Principal Programmer, DTL and VTL.
• This role will need to have a good knowledge of forms design, data flow, and the impact of design on the system.

EDUCATION

• Bachelor's Degree Health, clinical, biological or mathematical sciences, or related field.
• 3 years direct Data Management experience, including 1 or more years as a CDM project lead. Equivalent combination of education, training and experience.
•  Previous experience and proven competence in managing study delivery through full DM life-cycle (at least 1 medium Phase III).
• Demonstrated data management skills and thorough knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology).
• 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 applicable regulatory guidelines.

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Job Description

JOB OVERVIEW

• The Forecast Analyst is responsible for becoming the subject matter expert for IQVIA’s Clinical Trial Payment department’s forecasting service and for driving the quality of forecast for the assigned studies.
• Duties include preparing, delivering and analyzing the forecast report and becoming the interface for the CTP Client service Leads and RDS Project team members.
• Duties also include responding to inquiries from internal and external sources regarding the forecast report, adjusting the assumptions as needed, and validating the forecast report data against actual data to ensure maximum accuracy and client satisfaction.
• Additionally, the Forecast analysts carry the QA responsibility for the Forecasting application developments and enhancements.
• Clinical trial forecasting is a critical function in clinical trial financial management.
• IQVIA is offering this new service so sponsors no longer have to invest time and effort manually gathering and analyzing clinical trial study and financial data from various systems to predict future trial costs.
• A forecast analyst enters study visits and financial data into the solution so consolidated, monthly study activity reports can be provided to sponsors.
• A forecast analyst should possess typical financial analysis skills, methods, and tools familiarity (e.g.  MS Excel) at minimum.
• The more a candidate understands clinical research operations including reading protocols, the better equipped they will be to move quickly towards clinical trial finance subject matter expertise.

Essential Functions

• Communicate with internal & external stakeholders to understand each clinical trial receiving the forecasting service
• Build and develop baseline assumptions used in the forecast
• Determine if all forecasting requirements are met & helping to meet those requirements
• Work with IT to ensure successful loading of the assumptions into the forecast model
• Produce and distribute the forecast report to end-users; Answer and support end-user questions and needs
• Drive the QA testing for the Forecasting Application developments and enhancements
• Analyze & validate forecasting report output against actual data and make updates as needed
• Adjust the forecast report assumptions throughout the trial as needed to maintain accuracy
• Support the continued effort in updating IQVIA’s Clinical Trial Payment’s forecast enhancements
• Create, run, and analyze ad hoc reports as needed; Support the operations improvement initiatives as needed
• Other duties as assigned

Experience :

• Minimum 2-3 years of work experience, preferable in the pharmaceutical clinical trial, financial, or IT roles/industries

Knowledge :

• Requires intermediate level knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education combined with experience

Education :

• Bachelor's Degree: IT, Accounting, Finance, Statistics, Business or related field

Experience Details

• Working knowledge of clinical trial process, ideally with specific knowledge on investigator contracts and essential site documents;
• Experience in financial forecast and accrual reporting and analysis; Excel expertise
• Experience with a business intelligence application such as MicroStrategy or Spotfire

Skills and Abilities :

• Demonstrates customer-oriented communication skills, responding to both internal and external clients promptly and within agreed upon timeframes
• Strong aptitude for numbers, finance, and data analysis
• Requires strong attention to detail, excellent organizational, documentation and interpersonal skills
• Willingness to work within a team-oriented environment as well as independently
• Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential
• Strong PC skills (i.e. Microsoft Office) with an ability to understand, access and leverage technology alternatives

Advanced Excel skills required

• Prior experience with commercial reporting tools (i.e. Business Objects, MicroStrategy, Spotfire) and/or the ability to learn quickly
• Willingness to be flexible as the business requires

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Job Description

Job Overview :

• Project Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients’ lives by bringing new drugs to the market faster.
• The Project Lead is an essential member of the core project team responsible for project delivery of clinical studies to meet contractual requirements in accordance with SOPs, policies and practices.
• Clinical Project Management is focused on project delivery, productivity and quality resulting in strong financial performance and customer satisfaction.
• Clinical Project leads can run their own studies. The Project Lead focus is on leveraging therapeutic expertise and IQVIA’s suite of solutions to drive operational excellence and strategic leadership with our customers

Essential Functions :

• Participate in bid defense presentations in partnership with Business Development and may lead the presentation for smaller, less complex regional studies.
• May be responsible for delivery and management of smaller, less complex, regional studies.
• Develop integrated study management plans with the core project team.
• Accountable for the execution of clinical studies, or assigned portion of clinical studies, per contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
• Set objectives of the core project team and/or sub-team(s) according to agreed upon contract, strategy and approach, effectively communicate and assess performance.
• Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
• Monitor progress against contract and prepare/present project and/or sub-team information proactively to stakeholders internally and externally.
• Manage risk (positive and negative) and contingencies proactively and lead problem solving and resolution efforts.
• Achieve project quality by identifying quality risks and issues, responding to issues raised by project team and/or sub-team members and planning/implementing appropriate corrective and preventative action plans.
• May serve as primary or backup project contact with customer and would then own the relationship with the project’s key customer contacts, as well as communicate/collaborate with IQVIA business development representatives, as necessary.;
• Build the cross-functional project team and lead their efforts; responsible for managing cross-collaboration of the core team and for overall project delivery to support milestone achievement and to manage study issues and obstacles.;
• Ensure the financial success of the project.
• Forecast and identify opportunities to accelerate activities to bring revenue forward.
• Identify changes in scope and manage change control process as necessary.
• Identify lessons learned and implement best practices.
• May be assigned as the primary contact for vendors leading project vendor management and vendor management related activities as per project requirements.;
• Adopt corporate initiatives and changes and serve as a change advocate when necessary.
• Provide input to line managers of their project team members’ performance relative to project tasks.
• Support staff development and mentor less experienced project team members on assigned projects to support their professional development.;

Qualifications:

• Bachelor's Degree Life sciences or related field Req
• 5 years of prior relevant experience including > 1 years project management experience or equivalent combination of education, training and experience. Req
• Advanced knowledge of job area, and broad knowledge of other related job areas, typically obtained through advanced education combined with experience. Req
• Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. Broad protocol knowledge; therapeutic knowledge desired. Good understanding of the competitive environment and how to communicate/demonstrate value through IQVIA solutions.;
• Communication - Strong written and verbal communication skills including good command of English language. Strong presentation skills.
• Problem solving - Strong problem solving skills.
• Leadership - Ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback, experience productively partnering cross functionally and with customers to advance work effectively and efficiently.
• Leadership - Ability to make decisions, bringing clarity to disparate information to inform actions and drive results.
• Organisation - Planning, time management and prioritization skills. Ability to organize resources needed to accomplish tasks, set objectives and provide clear direction to others, experience planning activities in advance and taking account of possible changing circumstances.
• Prioritisation - Ability to handle conflicting priorities.
• Quality - Attention to detail and accuracy in work. Results-oriented approach to work towards delivery and output.
• Quality - Demonstrated learning agility and openness to learning and keeping own knowledge and skill set current and evolving.
• IT skills - Good software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel and PowerPoint.
• Collaboration - Ability to establish and maintain effective working relationships with coworkers, managers and clients. Strong customer service skills.
• Cross-collaboration - Ability to work across geographies displaying high awareness and understanding of cultural differences.
• Finances - Good understanding of project financials including experience managing, contractual obligations and implications.
• IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, innovation, Ownership).

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Job Description

Job Overview

• Direct Site Management operations for a designated (sub-) region or a defined function within the (sub-) region.
• Develop plans to ensure the allocation of human, material, system and fiscal resources for assigned area of accountability.
• Determine strategic goals and objectives for designated (sub-) region and/or function ensuring operational alignment with senior management priorities.
• Lead (sub)-regional and/or functional strategic initiatives and work with senior management across disciplines to develop implementation plans.
• Home Based role requiring fluency in English.

Essential Functions

• Manage staff in accordance with organization’s policies and applicable regulations.
• Responsibilities include planning, assigning, and directing work.
• Appraising performance and guiding professional development.
• Rewarding and disciplining employees.
• Addressing employee relations issues and resolving problems.
• Approve actions on human resources matters.
• Direct the hiring and selection process for a function/ (sub-) region or office and work collaboratively with senior management to set targets for recruitment and retention across roles.
• Contribute to the formulation of effective strategic goals for Site Activation operations across (sub-) regions.
• Take ownership for strategic initiatives within assigned unit of accountability including development of measures for success.
• Provide leadership to ensure service offerings meet or exceed customer expectations.
• Ensure the improvement of the execution of Site Activation processes.
• Manage operational delivery to achieve outputs to pre-defined targets. Contribute to the provision of strategic leadership and approval for the resourcing process and outcomes, hiring targets and processes and onboarding and training standards.
• Provide a leadership role in resourcing process through continual evaluation of existing and future resource alternatives, pro-active planning and collaboration with Site Activation leadership and operational peers.
• Evaluate regional/functional workload, quality and budget metrics through regular review and reporting of findings.
• Collaborate with senior management and other functional leadership to improve efficiencies, project outcomes and quality metrics for Site Activation projects.
• Act as a coach and mentor for managers as they develop in their role.
• Work collaboratively with client representatives and other functional (site management) leadership to manage project related challenges and to achieve exemplary customer service.
• Pro-actively plan for appropriate Site Activation operations budget consumption and guideline managers in managing variances and in developing corrective fiscal action plans.
• Effectively communicate and describe all Site Activation service offerings to internal and external customers.
• Ensure quality and regulatory appropriateness and acceptance of all service offerings.
• Lead corporate or departmental quality or process improvement initiatives.
• Act as a client liaison for Site Activation function.

Qualifications

• Bachelor's Degree Healthcare or other scientific discipline preferred Req
• 10 years of clinical trials experience including 6 years’ experience in a leadership capacity.
• Full knowledge of the drug development process
• Full knowledge of applicable regulatory requirements, Standard Operating Procedures (SOPs), and company’s Corporate Standards
• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
• Excellent knowledge of budget management and resourcing
• Considerable working knowledge of medical terminology
• Excellent negotiating skills
• Ability to lead and motivate teams
• Ability to independently coordinate and manage new processes
• Ability to handle management/personnel issues
• Ability to work independently and to effectively prioritize tasks
• Ability to work within a matrix team environment
• Ability to establish and maintain effective working relationships with co-workers, managers and clients