Fresh Vacancies at IQVIA

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 and manage clinical risks through the project’s 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.
• 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.
• May contribute to the development of the clinical delivery strategy for 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 work as a primary Clinical Lead alongside other Clinical Leads to deliver large, global trials.
• 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
• Requires 5 years clinical research/monitoring experience or equivalent combination of education, training and experience.
• Requires basic 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.;
• 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 in addition to 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.wnership).

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Essential Functions

• Gather Study Set up requirements through discussion and communication with relevant stakeholders.
• With Minimal guidance - support, overview of validation of new Device integrations.
• Oversight & Perform regular Data cleaning activities to ensure clean data with quality and timely deliverables to sponsor.
• Ensure that all the deliverables are of expected quality standards and meet customer expectations.
• With guidance, ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work (SOW).
• Support Training of New joiners.
• Lead internal study meetings and internal/ sponsor audits and participate in Study Kick off meetings and other sponsor meetings.
• Tracks and manages the projects, oversee project progress, identify risks and take corrective action to rectify any errors as recommended as required.
• With Guidance manage & oversight the implementation of new technology / database revisions.
• Work closely with the programming team for process innovation and automation.
• Be compliant to trainings and eSOP reading.
• Provide review and expert opinion in developing, revising, and maintaining core operating procedures and working instructions.
• Communication with Line Manager, and other team members across functions should be collaborative.
• Perform other duties as directed by Line Manager.

Qualifications:

• Bachelor's Degree In health, clinical, biological or mathematical sciences, or related field with proven experience in Data Management Req
• 3-4 years direct Data Management experience, including a minimum of 1 year as a CDM project lead. Pref
• English Fluency Spoken and English Advanced
• Advanced computer applications like Microsoft excel, word, Inbox etc Advanced
• Should have Advanced understanding of Drug development lifecycle and Overall Clinical research process Advanced