Openings at IQVIA

Job Description

Job Overview

• Perform monitoring and site management work for a variety of protocols, site and therapeutic areas.

Essential Functions

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• 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 / ICH 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.
• Act as a mentor for clinical staff including conducting co-monitoring and training visits.
• 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 in scientific discipline or health care preferred. Req
• Requires at least 3 years of year of on-site monitoring experience.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Strong 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.

go to method of application »

Job Overview

• Provide basic and some comprehensive data management expertise to the Clinical Data Management (CDM) team to provide efficient, quality data management products that meet customer needs.
• May also undertake team leadership activities under the supervision of the Data Operations Coordinator (DOC), Data Team Lead (DTL), or Functional Manager.

Essential Functions

• Serve as a Data Operations Coordinator (DOC) for one protocol with less then 5 operations staff (excludes DE) or 15+ easy to moderately complex central laboratory studies, or serve in a leadership role in a specific data management task (e.g., coder, tester or database designer for technologies that don't require extensive programming expertise) with guidance.
• May serve in the role of back-up to a DOC or DTL.
• May conduct data review.
• May write and resolve data clarifications.
• May lead database audit team.
• May develop and test databases and edit specifications.
• May perform testing of programming.
• May perform clinical data coding. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with CDM team."

Qualifications

• Bachelor's Degree Clinical, biological or mathematical sciences, or related field Req
• Equivalent combination of education, training and experience in lieu of degree.
• 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 coworkers, managers and clients.
• 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 coworkers, managers and clients.

go to method of application »

Job Description

Responsibilities:

Migration and Integration Role:

• Engage strategically with customer business and technical partner functions, providing guidance on data operations specific to migration, integration, and customer master data management.
• Evaluate customer requirements related to data and business migration, business integration, business reporting, field force structure, and territory alignment.
• Manage the customer master data linking process as part of the Data Migration process.
• Collaborate closely with Data Management and QA Heads of Departments (HODs) based on instructions from the Data Integration (DI) Manager and Key Account Manager (KAM).
• Communicate estimated delivery timelines to customers.
• Deliver files to customers along with relevant statistics.
• Support the linking of customer master data to IQVIA/Medpages unique identifiers.
• Conduct in-depth reviews of system functional specifications or provide IQVIA/Medpages -driven functional specifications.
• Plan and coordinate daily activities related to data integration to enhance operational effectiveness for customers.
• Assist with project plan preparation and manage projects to successful and timely completion.
• Provide IT-developed and approved quotes for all integration jobs and ensure timely invoicing.
• Ensure testing and validation processes are in place for all data files/formats to meet customer specifications.
• Review, QA, and provide final sign-off on all new file formats.
• Liaise with the IQVIA/Medpages contracts manager to ensure Third-Party Agreements and NDAs are in place for all customer vendors assisting with data integration.
• Identify new business opportunities and participate in sales activities to contribute to company growth.

Business Analyst (Reporting):

• Run data analytics regarding IQVIA/Medpages statistics and Data Quality and Completeness for customers, Sales, Contracts, and Finance as ad hoc reporting.
• Generate ad hoc reports for external customers, primarily using Qlik and PowerBI.

General:

• Undertake general administrative duties as required by the business.
• Manage tasks and calls on CRM and IT applications, ensuring due dates are met and tasks are effectively prioritized.
• Efficiently use all IQVIA/Medpages and IQVIA applications and systems as per company standards.

Qualifications and Experience:

• Minimum 3 years of relevant qualifications.
• Minimum 5 years of relevant working experience.
• Solid project management skills and client influencing and relationship-building skills.
• Ability to work effectively with others across the organization to accomplish team goals.
• Demonstrated analytical problem-solving capability with both systems and workflows.
• High attention to detail with strong written and verbal communication skills.
• Proficiency in CRM systems and MS Office applications.
• Good knowledge of different BI Reporting tools to assist customers with reporting solutions.
• Experience in analytics, data science, or other quantitative domains.
• Strong communicator with an orientation towards impact, comfortable working cross-functionally and independently.
• Excellent presentation, communication, and client influencing skills.
• Experienced with Business Intelligence tools (e.g., Qlik and PowerBI).
• Hands-on experience with experimentation, including design, implementation, and methodologies for analysing and interpreting results to stakeholders.
• Flexibility and a champion of change.

go to method of application »

Job Description

• Through our comprehensive training programme, you will become an expert reviewer, specializing in pharmaceutical industry compliance whilst also expanding your transferable skills.
• Reporting directly to the Account Lead and indirectly to the Account Manager, you’ll ensure that the Technical Review tasks assigned to you are completed on time and within budget.
• You’ll escalate task concerns or bottlenecks to the account/medical team in a timely manner.
• When needed you may be required to perform other account tasks to support the business.

Role and responsibilities

• Responsible for the technical review (first review) of customer materials.
• Ensure all tasks are appropriately added to WIP from the customers review and approval system and that all tasks are estimated (time to complete, TR, QC etc.) and checked with the AM
• Attend account WIP meetings to learn which tasks you will be responsible for completing, and escalate any concerns/issues
• Provide account support on ancillary tasks as required
• Ensuring up-to-date knowledge regarding a variety of therapeutic areas and client products; attend relevant training.
• Attend monthly mentorship sessions held by medical leads on topics of interest
• Maintaining up-to-date knowledge of Codes of practice (ABPI, IPHA, EFPIA, PhRMA) including any updates.

Key requirements for role

• Life science degree or equivalent
• High levels of attention to detail
• Excellent time management
• Highly organised and enjoy working in fast-paced role working on many tasks
• Excellent written and oral communication skills
• A fundamental understanding of statistical analysis
• Experience in problem-solving and providing solutions
• Willingness to learn new skills
• Fluency in English language

Desirable

• Pharmacist or Medical Qualification
• Signatory/AQP expertise
• Life science masters or PhD (MSc, MRes, MPharm, MBBS, or PhD), ideally in a subject including human, disease and therapeutics
• Knowledge of the applicable Codes of practice, including ABPI Code of Practice, EFPIA Code, PhRMA Code
• Experience working in Veeva Vault PromoMats/MedComms, Aprimo or similar review and approval system
• Preferably locations: UK, Spain, Portugal, South Africa, & Poland. This role is not eligible for UK visa sponsorship.

go to method of application »

Job Description

Job Description Summary

• Looking out for data management expert, who has prior experience in performing scientific (complex) clinical data review in close collaboration with the Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS) in the past for at least a duration of 1+ years.
• Prior experience of closely collaborating with the SRP, SRS, Data Management functions and the rest of the study team members when implementing the data management related activities for protocols, with focus on more complex indication and therapy related elements of the study.
• Has prior experience of being involved and driving discussions with SRP/SRS and collaborates with the Data management team to establish, align, and confirm scientific clinical data review expectations for assigned trial(s).
• Extensive prior experience of 4+ years supporting studies within the therapeutic area Oncology or CV&M.

go to method of application »

Job Description

Minimum Experience

• Bachelor in Science/Computer Science/Information Technology or Bachelor in Technology with 8 to 10 years’ experience OR equivalent combination of education and experience.
• At least 7+ years of CRO experience with knowledge of clinical systems, the data points stored within them and data flow paths.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Experience working in Drug Discovery, clinical trial conduct, clinical data management or related industries.
• Excellent critical thinking and analytical skills, strong attention to detail
• Effective written, interpersonal, and verbal communication skills
• Strong influencing, problem resolution, motivation, and negotiation skills
• Solution-oriented approach to challenges
• Sound leadership and customer service skills
• Competent presentation skills meeting the needs of all levels
• Ability to establish and maintain effective working relationships with team members, management, operations staff, clients, and executive management.
• Ability to lead effective meetings.
• Strong organizational and time management skills.
• Ability to manage multiple dependencies across multiple systems to reach a final deliverable.
• Ability to establish and maintain effective working relationships with teams involved in study start up.

RESPONSIBILITIES

• Work directly with project teams to guide/convey optimal data flow design patterns across the enterprise consisting of multiple systems with the end goal to ensure data integrations enable real time Alerts and Analytics
• Lead vendor data set-up for all Data Management vendors. Work closely with the DTL to enable data flow for all DM downstream activities (data cleaning, etc).
• Complete and manage the 'Systems Integration Plan' to detail the data flow and highlight potential risks/challenges while collaborating with various groups (i.e. IPA, Study Team, CDAT) to provide data standardization and alignment of site visits across systems”.
• Champion people, process and technology improvements and standards to enhance quality, increase productivity (internal and external with Investigator sites) and reduce data latency within Quintiles clinical trial systems inclusive of IVxS, EDC, CTMS, QRPM, Data Factory, Triggers and Alerts, Visualizations such as Infosario Analytics and Federated reports, CDOS and SLDRs.
• Guide and present study teams with best case options given limitations (e.g. contract, cost, timelines, etc.) with the ability to articulate pros and cons of each approach.
• Identify and implement innovative solutions to challenges and influence future decision-making in order to reduce workarounds.
• Review data transfers specifications to ensure they meet the standards required to develop quality data integrations.
• Proactively provide education and training to ensure adherence of the relevant startup SOPs and best practices during the RFI and post-award phases.
• Collaborate with the global IT organization as needed to resolve support issues related to data integration or data quality.
• Ability holistically understands the process and structure of 5-10 individual systems and determine how the design of one system may impact the ability of another system to function optimally.