Associate Data Team Lead (Extended Training Program)

PURPOSE:
Assist with or manage the 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. May perform role of Data Team Lead (DTL), Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.

JOB DESCRIPTION:

• 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)/ Global Data Team Meeting

• Participate in the development and implementation of new technology or tool

• Provide review and input on developing, revising, and maintaining core operating procedures and work instructions

• Perform other duties as directed by the DTL or Functional manager

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

• Develop and Maintain strong customer relationships

• Maintain the Data Management study files in the audit ready condition.

• Ensure open communications with customer and IQVIA management to manage and meet contractual obligations

Service Management:

• Attend and facilitate meetings 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

• Assist with workflow and timeline management of UAT

• 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

• Continuously look for opportunities to improve service; work with team to develop and implement plan to re-organize and drive change across multiple projects/programs (with minimal support)

• Ensure timely follow-up and resolution of compliance issues

• 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)

• Participate in the review of financial reports on a monthly basis and participate in project reviews as requested

• Identify out of scope tasks and track change orders to completion

• Independently bring solutions to the CDM team/CDM department

• Lead and/or participate in a focus team or global or local standard methodology 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

• Perform other duties as directed by the functional manager

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:

• 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 GCP and relevant regulatory guidelines

• Excellent communication, interpersonal, customer service, and teamwork skills

• Excellent project management skills

• Excellent organizational and analytical skills

• Comprehensive understanding of clinical drug development process

• Demonstrated extensive data management skills and thorough knowledge of the data management process (e.g., therapeutic area, deep understanding in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology)

REQUIRED EDUCATION AND EXPERIENCE:

• Bachelor's Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related discipline, and 3 years direct Data Management experience, including 1 or more years as a CDM project lead; or equivalent combination of education, training and experience

• Previous experience and shown competence in leading delivery of multiple projects through full DM life-cycle (several studies/programs)

• 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 GCP and relevant regulatory guidelines

• Excellent communication, interpersonal, customer service, and teamwork skills

• Excellent project management skills

• Excellent organizational and analytical skills

• Comprehensive understanding of clinical drug development process

• Occasional travel is required

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.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.