IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients.
Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
Clinical Data Team Lead - Homebased - Real World As this role is homebased that home base can be located in any of the follow countries UK, France, Italy , Spain, Portugal , Czech Republic, Bulgaria, Romania Greece and Poland.
You must be eligible to live and work in the country to which you are applying without visa sponsorship. To be considered you application should be in English PURPOSE Manage end-to-end delivery of data management services for single / multi-service projects, ensuring quality deliverables on time and within budget, to customer satisfaction.
Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs.
communications; and milestone deliverables. May perform role of Data Team Lead (DTL), Program Lead, and / or a leadership role in a specific CDM task (e.
g. Subject Matter Expert (SME). Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.
RESPONSIBILITIES Client Management : + Serve as primary point of contact for customer on 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.
work with client data managers, vendors, 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 + Ensure service and quality meet agreed upon specifications per the DMP and contract / SOW + Implement proactive quality management plans across multiple projects / programme.
work with team to develop and implement plan to re-organise and drive change across multiple projects / programme (with minimal support) + Ensure timely follow-up and resolution of compliance issues + Serve as Subject Matter Expert (SME) - Provide leadership and expertise in a specific CDM task or technology + Train and mentor junior DTL staff in DM expertise.
May coordinate the work of more junior DTL staff + Maintain internal tracking databases and systems Financial Management / Business Development Support : + Ensure service and quality meet agreed upon timelines and deliverables in contract / Scope of Work (SOW) + Manage SOW / budget - Review financial reports on a monthly basis and participate in project reviews as requested - Identify out of scope tasks and track change orders to completion + Serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing + Participate in and support RFP process (review RFP documents, pricing, attend bid defence) Other : + Independently bring solutions to the CDM team / CDM department + Lead and / or participate in a focus team or global or local best practice team + Communicate lessons learned and / or present in CDM workshop(s) + Participate in the development and implementation of new technology or tool + Present at professional conferences and / or publish articles in professional journals + Provide review and input on developing, revising, and maintaining core operating procedures and work instructions + Perform other duties as directed by the functional manager REQUIRED EDUCATION KNOWLEDGE, SKILLS AND EXPERIENCE + Bachelor's Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field, and moderate direct Data Management experience, this includes having been as a CDM project lead + Previous experience and proven competence in managing delivery of multiple projects through full DM life-cycle (several studies / programmes) + Demonstrated expert 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) + Previous experience of handling customer negotiations + 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 + Fluency in English both written and verbal + Excellent project management skills + Excellent organizational and problem-solving skills + Ability to work independently with available resources, e.
g., functional managers, senior DTLs + Comprehensive understanding of clinical drug development process + Ability to establish and maintain effective working relationships with coworkers, managers and customers Join Us Making a positive impact on human health takes insight, curiosity, and intellectual courage.
It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning. At IQVIA, we have a vision. Where every healthcare decision is based on evidence.
Where data science and human science come together to improve global health. Where new and creative solutions aren't just possible - they are expected.
Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare.
The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease.
We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you're supported to succeed.
EEO Minorities / Females / Protected Veterans / Disabled