Jobs at IQVIA

Job Overview

• Project Management Analysts (PMA) 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 PMA works in partnership with the Project Leader (PL)/Clinical Project Manager (CPM) providing support with project management activities to mitigate risk, control cost, manage project schedule, and ensure customer satisfaction related to assigned project/s.

Essential Functions

• Establish and manage performance dashboards, analyze event triggers/alerts and determine appropriate follow up for Project Leader (PL) or other function(s) to act upon.
• Coordinate project schedule and ensure timely updates of all key milestone and partner with PL on related calls.
• Coordinate and support the risk and issue management process.
• Manage all aspects of the Project Finances including Estimate at Completion (EAC), monthly expenses, invoices and reconciliation.
• Demonstrate compliance with the Vendor and Purchase Order (PO) Management process.
• Implement and maintain baseline and change control processes.
• Ensure PL has timely and accurate data on areas including cost, schedule, scope, utilization, change orders and quality to support better decision-making.
• Develop and maintain relevant sections of Project Management Plans.
• Review and support project resource allocation within project budgeted for assigned portfolio/ projects.
• Prepare correspondence, including meeting minutes, for project team and/or customer.
• Organize and partner with PL in managing internal project team and customer meetings.
• Prepare project status reports and presentation materials for internal project team and customer meetings.
• Manage and coordinate core file reviews and support audits as needed. Drive e Trial Master File (eTMF) filing compliance focusing on completeness, timeliness and quality.
• Manage project specific eTraining and oversee compliance.
• Coordinate and support onboarding of new Key Project Team Members and system access.
• Monitor project metrics and make required updates in IQVIA systems to ensure accurate and timely reporting is available to senior management.
• Participate in regional initiatives to support Project Management Analyst (PMA) community and aid personal development.

Qualifications

• Bachelor's Degree Life sciences or other related field.
• Typically requires 0 - 2 years of prior relevant experience.
• Requires knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education.
• 1 year of relevant clinical research experience with analytical/financial skills or relevant Project Management experience or equivalent combination of education, training, and experience.
• Knowledge of clinical trials - knowledge of clinical trial conduct and skill in applying applicable clinical research regulatory requirements i.e. International Conference on Harmonization (ICH), Good Clinical Practice (GCP), relevant local laws, regulations, and guidelines, towards clinical trial conduct.

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Job Overview

• Project Management Analysts (PMA) 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 PMA works in partnership with the Project Leader (PL)/Clinical Project Manager (CPM) providing support with project management activities to mitigate risk, control cost, manage project schedule, and ensure customer satisfaction related to assigned project/s.

Essential Functions

• Establish and manage performance dashboards, analyze event triggers/alerts and determine appropriate follow up for Project Leader (PL) or other function(s) to act upon.
• Coordinate project schedule and ensure timely updates of all key milestone and partner with PL on related calls.
• Coordinate and support the risk and issue management process.
• Manage all aspects of the Project Finances including Estimate at Completion (EAC), monthly expenses, invoices and reconciliation.
• Demonstrate compliance with the Vendor and Purchase Order (PO) Management process.
• Implement and maintain baseline and change control processes.
• Ensure PL has timely and accurate data on areas including cost, schedule, scope, utilization, change orders and quality to support better decision-making.
• Develop and maintain relevant sections of Project Management Plans.
• Review and support project resource allocation within project budgeted for assigned portfolio/ projects.
• Prepare correspondence, including meeting minutes, for project team and/or customer.
• Organize and partner with PL in managing internal project team and customer meetings.
• Prepare project status reports and presentation materials for internal project team and customer meetings.
• Manage and coordinate core file reviews and support audits as needed. Drive e Trial Master File (eTMF) filing compliance focusing on completeness, timeliness and quality.
• Manage project specific eTraining and oversee compliance.
• Coordinate and support onboarding of new Key Project Team Members and system access.
• Monitor project metrics and make required updates in IQVIA systems to ensure accurate and timely reporting is available to senior management.
• Participate in regional initiatives to support Project Management Analyst (PMA) community and aid personal development.

Qualifications

• Bachelor's Degree Life sciences or other related field.
• Typically requires 0 - 2 years of prior relevant experience.
• Requires knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education.
• 1 year of relevant clinical research experience with analytical/financial skills or relevant Project Management experience or equivalent combination of education, training, and experience.
• Knowledge of clinical trials - knowledge of clinical trial conduct and skill in applying applicable clinical research regulatory requirements i.e. International Conference on Harmonization (ICH), Good Clinical Practice (GCP), relevant local laws, regulations, and guidelines, towards clinical trial conduct

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Job Overview

• Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. The therapeutic area covered is Oncology.

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 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.
• 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, Knowledge and Skills

• Bachelor's Degree Degree in scientific discipline or health care preferred.
• Requires at least 2 - 3 years of on-site monitoring experience.

Oncology experience essential.

• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
• Good therapeutic and protocol knowledge as provided in company training.
• Experience in Inflammatory Bowel Disease (IDB) is an advantage
• 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.

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Advance level role

• Provide timely status updates including issues & risks to DM and DMLs as needed
• Act as the Point of contact for Clinical Data Manager, working pro-actively to identify risks and provide mitigations
• May communicate with the vendors to resolve reconciliation issues.
• Provide input to Study set up activities including but not limited to creation of DVRs
• Create and/or provide inputs to Data Management documents (e.g. eCRF completion guidelines, etc.).
• Review and provide inputs to Data Management documents (e.g. IRP, DMP, etc.)
• Assign work to allocated CDAs on a trial. Coordinate work of CDAs assigned to a study working closely with the Global Data Manager to understand priorities and timelines.
• Assist the Data Management Leader in TMF compliance reviews.
• Train and mentor CDA staff
• May serve as an SME and participate in SME forums
• May act as delegate for Data Manager, as needed

Education and Experience Guidelines:

• Bachelor’s degree in a Health or Science discipline with experience in clinical research.
• Experience CDA ADVANCED level: >3 year of experience Data Management experience
• Data Management experience and experience working on a clinical trial mandatory.
• Rave experience mandatory
• Experience working in highly diverse teams within clinical research; cross-functional, global, multi- regional.
• Knowledge of current industry standards (e.g., CDISC, SDTM, CDASH, etc.) for Advanced CDA.
• Knowledge of technology platforms and systems to capture and process data
• Project management skills.
• Vendor management skills.
• Proficiency with Microsoft Office tools