PURPOSE Manage end-to-end delivery of data management services for single / multi-service projects with minimal guidance, 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.
and milestone deliverables. Perform role of Data Team Lead (DTL). 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 With minimal guidance, 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 With guidance, provide input for and perform direct negotiations with customer, e.
with guidance, 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 With guidance, create and / or review and sign-off on all data management plan (DMP) documents Implement proactive quality management plan.
Identify any service and quality issues with agreed upon specifications per the DMP and contract / SOW and work with functional manager(s) to resolve With guidance, track service performance and provide leadership to identify root causes of issues and implement remedial actions Continuously look for opportunities to improve efficiency of tasks and quality of deliverables Identify compliance issues and work with functional manager(s) to ensure timely follow-up and resolution With guidance, maintain internal tracking databases and systems Financial Management / Business Development Support : With guidance, 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 With guidance, may serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing With guidance, participate in and support RFP process (review RFP documents, pricing, attend bid defense) Other : Provide input on DM process improvements or project solutions to CDM team / CDM department Provide input on the development and implementation of a new technology or tool Participate in a focus team or global or local best practice team Perform other duties as directed by functional manager(s) REQUIRED KNOWLEDGE, SKILLS AND ABILITIES 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 Excellent communication, interpersonal, customer service, and teamwork skills Excellent organizational and problem-solving skills Excellent project management skills Ability to work with minimal supervision, using available resources, e.
or equivalent combination of education, training and experience PHYSICAL REQUIREMENTS Extensive use of telephone and face-to-face communication requiring accurate perception of speech Extensive use of keyboard requiring repetitive motion of fingers Regular sitting for extended periods of time Occasional travel is required 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.
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