RESPONSIBILITIES  

Client Management:

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 studies/programme 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

Maintain strong customer relationships

Ensure open communications with customer and Quintiles management to independently 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; provide training and development on data management expertise to junior team members

Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders

Independently manage DM service delivery with comprehensive DM process and technical expertise in executing projects

Serve as the escalation point for unresolved data issues; independently work with client data managers, vendors, internal team members for resolution

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/programmes/customer account. Manage service performance and provide leadership to identify root causes of issues and implement remedial actions

Continuously look for opportunities to improve service; develop and work with team to implement plan to re-organise and drive change (possibly across a customer account)

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

Serve as customer site lead for one or more customers

Train and mentor junior DTL staff in DM expertise; may coordinate the work of more junior DTL staff

Independently 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)

Independently 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

Participate in pricing discussions across customer account

Serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing

Independently support RFP process (review RFP documents, pricing, attend bid defense)

Other:

Independently bring process improvements and solutions to the CDM team/CDM department

Lead a focus team or global or local best practice team

Communicate lessons learned and/or present in CDM workshop(s)

Manage the development and implementation of new technology or tool

Present at professional conferences and/or publish articles in professional journals

Provide review and expert opinion in developing, revising, and maintaining core operating procedures and work instructions

Perform other duties as directed by the functional manager

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, management of local laboratory data, and/or new technology)

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    

MINIMUM REQUIRED EDUCATION AND EXPERIENCE     

Bachelor’s Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field, and a minimum of 7 years direct Data Management experience, including 5 or more years as a CDM project lead; or equivalent combination of education, training and experience

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.