Job Openings at IQVIA

Job Description

• Clinical Trial Manager - IQVIA Biotech
• Please note: due to sponsor requirements for the role only candidates based in the listed location/s and with previous Global CTM experience will be considered. Any applications from candidates based outside of these locations will not be considered.

Job Overview

• Clinical Trial Managers (CTM) are an integral part of clinical trial delivery, leading and working alongside clinical teams to improve patients’ lives by bringing new drugs to the market faster. The CTM is a member of the core project team responsible for clinical delivery of full service, large, multi-regional studies to meet contractual requirements and in accordance with (Standard Operating Procedures) SOPs, policies and practices.

Essential Functions

• Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures  (SOPs), project plans).
• Accountable for meeting projects’ recruitment targets and ensuring appropriate recruitment strategies are in place.
• Contribute to the development of the project risk mitigation plan. Manage clinical risks through the project lifecycle.
• Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues.
• Manage clinical aspects of Project Finances including Estimate at Completion (EAC). Understand the scope of clinical delivery and create plans to deliver. Monitor and manage changes against baseline Estimate at Completion (EAC) and identify additional service opportunities or out of scope work.
• Work as the primary CTM alongside other CTMs to deliver large, global trials.
• Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management.
• Collaborate with the clinical team to support milestone achievements. Report to internal and external stakeholders as per project scope requirements.
• Resourcing and Talent Planning of the clinical team. Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance and project related trainings.
• Conduct regular team meetings and communicate appropriately to achieve objectives.
• Support professional development by providing feedback to clinical team line managers on performance relative to project tasks to support professional development.
• Adopt corporate initiatives and changes and serve as a change advocate when necessary.
• May contribute to the development of the clinical delivery strategy for business proposals. Participate in bid defense preparations and meetings. Develop and present Clinical Operation plan in partnership with Business Development and Project Leadership.
• May mentor and coach new peers as they assimilate into this role.
• May attend site visits as applicable in support of project delivery.

Qualifications

• Bachelor's Degree Bachelor's Degree in health care or other scientific discipline required

Experience

• Ideally at least 2 years experience in clinical trial management or equivalent combination of education, training and experience.
• Requires consolidated knowledge of Project management practices and terminology.
•  Requires good knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Requires broad protocol knowledge and therapeutic knowledge.; Req
• Requires good understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates.
• Requires understanding of project finances.
• 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) and Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct.;

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Job Description
Job Overview

• Responsible for study build & design, edit specifications, system configurations and is accountable for associated study design components. This role will collaborate with various stakeholders- DTL, Programmer, Validation Team, vendors, statisticians, and client representatives. In addition to project deliveries, the role also would be responsible for the project financials from programming shared services perspective.

Essential Functions

• Interprets the study protocol.
• Design and update the eCRF using third party or in house CDMS tools in alignment with industry standards like SDTM, CDASH as applicable.
• Create and update Edit Specification Document.
• Generate specifications for EDC build components (e.g., Rights and Roles, System Settings and Home Page)
• Complete the Study Authorization Form and Trial Capacity Request Form (InForm)
• Attend the Pre-Design Meeting, Online Screen Review Meeting, Unblinded Data review meeting.  Attend and present comments at the Internal Design Review Meeting.  May lead Online Screen Review Meeting.
• Facilitate the internal Edit Specification Review Meeting and leads the discussions regarding the Edit Specification Document.
• Design the database to collect LLRR data within the InForm database and ensure Rights and Roles document has appropriate access for Entry and Updates.
• Communicate any project risks to the Data Team Lead, including the potential for missing a timeline in the Data Management Project Plan.
• Escalate potential quality issues.
• Ensure the completion and documentation of all project-specific training, as well as staying current with required Standard Operating Procedures.
• Reviews build timelines and provide input as applicable.
• Reviews QIP for own projects, identify out of scope activities if any and inform relevant parties.
• Responsible for multiple study design projects at the same time.
• Might be working on projects across multiple platforms.
• Identify areas for process improvements on an ongoing basis. Actively take part and contribute towards process improvement initiatives as assigned besides providing suggestions for continuous improvement of processes.
• All responsibilities are essential job functions unless noted as nonessential (N).

Qualifications

• Bachelor's Degree Bachelor in Science/Computer science/Information Technology or Bachelor in Technology  Req
• 2-4 years of relevant core Technical designer experience and total exp being 7+ yrs.   Req
• IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide

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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
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    
• Working hours to accommodate global client and projects

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
• IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.