Job Opportunities at IQVIA

Job Description

• The IQVIA Global Site Activation team is one of the clear market leaders in Clinical Trial Site Activation, driving best in class employee, site and customer experiences. This position can be anywhere in Europe, remote.

Job Overview

• As a Global Site Activation Manager you will be our project manager for the Start-Up phase, in charge of the design and implementation of our strategy towards sites activation from award until open to enrolment. You will also oversees our country operations teams ensuring that our client commitments are delivered timely and according to project scope and processes.
• The key project team members that the SAM interacts with are; the project manager, the clinical lead, a regulatory and contract and budget solution advisors and the country regulatory specialists. The SAM also counts on a rich regulatory intelligence database and best in class systems to enable the start up strategy execution.
• The Site Activation Manager is a fundamental role to deliver our clinical trial portfolio and belongs to a global unit with vast career growth opportunities.

Qualifications

• Bachelor's Degree, Master's Degree or Ph.D in Life sciences or a closely related field.
• At least 5 years experience within the clinical research space with a minimum of 2+ years of experience overseeing global clinical studies.
• Project ownership controlling delivery on time, within scope and controlling budget.

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• The Client Services Lead serves as the main point of contact for global portfolios, manage the client relationship at the study level, oversee payment management projects and ensure sponsor satisfaction is achieved. Manage and oversee the initiation and study management of protocols including identifying all protocol related information, timelines, reporting and initial setup of proprietary software system used to initiate studies.

Essential Functions:

• Act as the primary point of contact for assigned sponsor(s) and Assocd studies.
• Manage the project timeline, identify/pursue change orders and coordinate with other stakeholders, as necessary.
• Prepare materials and KPI’s for sponsor Governance Meetings and participate as appropriate
• Identify and execute process improvement initiatives when appropriate.
• Prepare, arrange and execute regular client meetings and ensure all necessary materials are presented with accuracy and completeness.
• Function as the engagement leader providing management throughout the length of the clinical trial by overseeing activities of the project team to ensure sponsor commitments and IQVIA's service levels are achieved.
• Coordinate with Site Solutions and Data Operations to ensure proper resource assignment and service delivery quality.
• Ensure that IQVIA financial interests are appropriately protected through diligent scope of work  management efforts.
• Ensure support to the clinical trial sites is provided, at IQVIA’s levels of excellence, through timely resolution of issues that are raised via email and/or phone contact.
• Responsible for ensuring that payments do not exceed SOW timelines.
• Responsible for ensuring change orders are executed  and communicated to appropriate personnel.
• Responsible for performance review input to Site Solutions and Data Operations for roles that support assigned sponsor.
• Coordinate with the Site Solutions and Data Operations team members to prepare sponsor funding.
• Ensure that all IQVIA processes and standards  are followed and that appropriate financial controls are observed and are in line with sponsor requirements for managing and mitigating financial risk.
• Ensure work is SSAE 18 compliant.
• Responsible for monitoring, assist in resolving and escalating operational and performance metric issues.                                                                          
• Act as a central contact for the project team for designated project communications, correspondence and associated documentation.
• Participate in (study) team meetings/Project kick off meetings and interaction with cross functional staff to verify information and/or triage new data issues or prior identified action items.
• Perform Subject Level Data Review that require further investigation with the clinical site to determine overall accuracy (inclusion & exclusion criteria/ IP/AE/ Labs/EOT/EOS/ End points/SAEs etc.) Review any other information as necessary to determine overall readiness of the patient information for next level review. (CM-subject)
• Early identification of site-level risk/issue(s) occurring during study conduct and responsible for identification of risk pertaining to payments.
• Monitor site performance and make recommendations for timely corrective actions
• Assist the relevant stake holders within the project team in developing the study payment plans, tools and templates and maintain the team accountabilities as applicable.
• Provides inputs to cross functional team in managing project deliverables.

Our Ideal Candidate Will Have:

• Bachelor's Degree required.
• At least 3 years of related work experience in Clinical Trials, investigator payments or project management.
• General knowledge of Clinical Trial Industry preferred
• Comfortable representing Clinical Trial Payments to internal / external stakeholders
• Proficiency in Office tools applications, such as Excel and Power Point.
• Fluent English skills is a must and any other language will be considered as a plus.
• Broad knowledge of the concepts, practices and procedures of the client service representative field.
• Must be customer focused and have excellent written and oral communication skills
• High energy, self-starter with the ability to work in a team environment as well as independently
• Able to think independently, and to analyze and solve problems creatively 
• Strong time management, planning, and organizational skills Strong time management and planning skills
• Detail oriented, analytical and the ability to meet competing aggressive deadlines
• Comfortable working in a global company environment
• Ability to communicate effectively with various levels in the organization (written and oral) and to manipulate large transactional databases.
• Demonstrated problem solving, analytical and strong customer service skills.

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• The Clinical Trial Payments department uses the most advanced site payment solution available and offers service to customers to integrate/centralize all payments in a high tech software. This position will be responsible for managing core financial data implementation for contracts with CRO´s, clinical sites, clients and investigators, overseeing the site reimbursement processes of invoicing and accounts payables. This position is also responsible for initial site set-up within the proprietary software systems, collection of site required documentation, start up and pass through payments, receives incoming enrolment data, conducts data review and completes necessary edits, management of the visit payment process and ensuring satisfaction.

Summary of Essential Job Functions:

• Review and document each site contract for input of site specific data into designating tracking system, responsible for obtaining all critical information from client site.
• Manage client site banking information, responsible for integrity of electronic fund transfer (EFT) data for the life of the contract for processing of invoicing and payments.
• Responsible for requesting advance payments and processing of pass-through payments.
• Responsible for communicating with client sites in the normal processing of pass-through payments.
• Responsible for data integrity of contract terms as it is entered into designated systems in accordance with project requirements.
• Managing site inquiries escalated from Customer Support and update cases in our case management system.
• Creation and tracking of proforma invoices for international client sites.
• Generates invoicing for client sites, verifying financial data accuracy prior to issuance of same.

Requirements:

• Minimum of 1 year's accounting, payment coordination or project finance experience.
• Bachelor's Degree in Finance or equivalent combination of education, training and experience.
• Fluent English skills is a must and any other language will be considered as a plus.
• Russian language will be huge advantage for candidates
• Knowledge of revenue recognition, variance analysis, unbilled/unearned and cash flow management, and backlog forecasting.
• Knowledge of Peoplesoft Project.
• Experience with RPA or SAP or Power BI or Spot fire will be considered a plus.
• Good level of Microsoft Office applications.

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Job Description

• This unique role within IQVIA lends itself to a technically minded Project Manager with strong communication skills and SDTM knowledge. Having experience with SAS programming will also be a huge benefit. The role can be based remotely in Europe.
• This role is part of a sponsor dedicated project where you will be working with the client directly to manage Database Delivery from external vendors.
• The primary functions of this role will be to build study eCRFs in Formedix, define structure of datasets that are part of data transfer specifications and ensure quality and completeness of SDTM format data.

Main responsibilities include:

• Collaborate with Sponsor colleagues and CRO Partners to finalize the design, creation and implementation of EDC solutions
• In collaboration with Study Data Leads ensure the planning for data receipt and its oversight throughout the duration of assigned clinical trials
• Process data loads from various sources into the clinical and operational data repositories including the review and communication of issues.
• Program reports and contribute to the standardization of process and reports used for data review and analysis for external partners/vendors and internal teams
• Complete formal and ad-hoc analyses and oversight of SDTM data.
• Review of critical document/deliverable (SDTM Annotation, SDTM datasets) to ensure Data Standards are used consistently and support creation of DE dataset
• Attend meetings as applicable with Mission, Submission, Project, Program, JCST, DEM, Biometrics, Clinical & Regulatory Solutions Team (CRST), Early Phase
• Perform relevant quality checks and create standard edit checks for new CRF modules and share in the appropriate space
• Support audits and inspections as required and other responsibilities and projects that the Company may assign.

Experience:

• At least 5 years relevant experience in relational database design
• 2-3 years SAS experience preferred
• Experience with Data Management processes, to include:
• Review of SDTM annotated CRFs
• Writing and reviewing technical specifications
• Review of log files for errors and warnings
• Resolving/trouble shooting errors
• Experience with data mapping and SDTM Controlled Terminology
• Prior experience in a clinical or pharmaceutical related field is required.
• Prior experience in a Data Management related field is required
• Experience with relational databases, preferably Clinical Data Management and EDC Systems
• Advanced familiarity with reporting tools.
• Advanced knowledge of federal regulations, Good Clinical Practice, and Good Clinical Data Management Practices.
• Excellent command, both verbal and written, of English
   

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Job Overview:

• Perform, plan and co-ordinate the following for complex studies: (i) the programming, testing, and documentation of statistical programs for use in creating statistical tables, figures, and listing summaries and (ii) the programming of analysis databases (derived datasets) and transfers of data for internal and external clients. May perform and plan the programming of database quality control checks.

Program and plan the integration of databases from multiple studies or sources.

• Develop and co-ordinate programming documentation including plans and specifications, as appropriate, for complex studies.
• Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to teams and department, for complex studies.
• Fulfil project responsibilities at the level of statistical team lead for single complex studies or group of studies.

Requirements: 

• Bachelors or Masters’ in Computer Science, Mathematics or equivalent
• 5+ years Statistical Programming experience within the Life-Science industry 
• Experience in SAS® Base, and good knowledge of SAS® graph and SAS® Macros
• Excellent knowledge of CDISC standards (SDTM and ADaM)
• Excellent application development skills
• Strong understanding of clinical trial data and extremely hands on in data manipulations, analysis and reporting of analysis results.
• Experience as technical team lead, directly engaging clients and coordinating tasks within a programming team
• In-depth knowledge of applicable clinical research regulatory requirements, i.e. Good Clinical Practice
• (GCP) and International Conference on Harmonization (ICH) guidelines

Join IQVIA to see where your skills can take you

• Global exposure 
• Variety of therapeutic areas
• Collaborative and supportive team environment 
• Access to cutting-edge and innovative, in-house technology
• Excellent career development and progression opportunities 
• Work-Life Balance, with a strong focus on a positive well-being