Vacancies at IQVIA

Responsibilities
Client Management

• Serve as primary point of contact for customer on clinical data management deliverables
• 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
• Provide justification for and perform direct negotiations with customer, e.g., timelines, financial, process, resource
• Maintain strong customer relationships
• Ensure open communications with customer and Quintiles management to manage and meet contractual obligations

Service Management

• Meet with Data Operations Coordinator (DOC) and/or Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables
• Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders
• Support DM service delivery with comprehensive DM process and technical expertise in executing projects
• Serve as the escalation point for unresolved data issues; work with client data managers, vendors, and internal team members for resolution
• Work with functional manager(s) to ensure appropriate resources are assigned to meet project deliverables
• Create and/or review and sign-off on all data management plan (DMP) documents
• Implement proactive quality management plans across multiple projects/programme. Track 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
• Maintain internal tracking databases and systems

Qualifications

• Bachelor’s Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field
• 5+ years direct Clinical Data Management experience in CRO or pharmaceuticals industry , including 3+ years as a CDM project lead; or equivalent combination of education, training and experience
• Previous experience and proven competence in managing delivery of multiple projects through full DM life-cycle (several studies/programmes)
• Previous experience of handling customer negotiations
• Knowledge of Good Clinical Practices and relevant regulatory guidelines
• Excellent communication, interpersonal, customer service, and teamwork skills
• Comprehensive understanding of clinical drug development process
• Ability to establish and maintain effective working relationships with co-workers, managers and customers

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Essential Functions

• Participate in bid defense presentations in partnership with Business Development and may lead the presentation for smaller, less complex regional studies.
• May be responsible for delivery and management of smaller, less complex, regional studies.
• Develop integrated study management plans with the core project team.
• Accountable for the execution of clinical studies, or assigned portion of clinical studies, per contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
• Set objectives of the core project team and/or sub-team(s) according to agreed upon contract, strategy and approach, effectively communicate and assess performance.
• Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
• Monitor progress against contract and prepare/present project and/or sub-team information proactively to stakeholders internally and externally.
• Manage risk (positive and negative) and contingencies proactively and lead problem solving and resolution efforts.
• Achieve project quality by identifying quality risks and issues, responding to issues raised by project team and/or sub-team members and planning/implementing appropriate corrective and preventative action plans.
• May serve as primary or backup project contact with customer and would then own the relationship with the project’s key customer contacts, as well as communicate/collaborate with IQVIA business development representatives, as necessary.;
• Build the cross-functional project team and lead their efforts; responsible for managing cross-collaboration of the core team and for overall project delivery to support milestone achievement and to manage study issues and obstacles.;
• Ensure the financial success of the project.
• Forecast and identify opportunities to accelerate activities to bring revenue forward.
• Identify changes in scope and manage change control process as necessary.
• Identify lessons learned and implement best practices.
• May be assigned as the primary contact for vendors leading project vendor management and vendor management related activities as per project requirements.;
• Adopt corporate initiatives and changes and serve as a change advocate when necessary.
• Provide input to line managers of their project team members’ performance relative to project tasks.
• Support staff development and mentor less experienced project team members on assigned projects to support their professional development.;

Qualifications

• Bachelor's Degree Life sciences or related field
• 5 years of prior relevant experience including > 1 year of project management experience with a CRO.
• Advanced knowledge of job area, and broad knowledge of other related job areas, typically obtained through advanced education combined with experience.
• Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct.
• Broad protocol knowledge; therapeutic knowledge desired. Good understanding of the competitive environment and how to communicate/demonstrate value through IQVIA solutions.;

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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.; Req
• 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. Req
• 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.