Senior Data Team Lead, FSP at IQVIA

Bloemfontein, Free State, South Africa

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, PharmaceuticalsIndustries

Requirements

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)
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
Working hours to accommodate global client and projects
Bachelor’s Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field
Around 7 years direct Data Management experience, including 5 or more years as a CDM project lead; or equivalent combination of education, training and experience

Responsibilities

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 programs 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
Meet with Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables
Independently manage DM service delivery with comprehensive DM process and technical expertise in executing projects
Serve as the escalation point for unresolved data issues
Ensure appropriate resources are assigned to meet project deliverables
Create and/or review and sign-off on all data management plan (DMP) documents
Manage 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
Independently manage SOW/budget
Independently bring process improvements and solutions to the CDM team/CDM department
Lead a focus team or global or local best practice team
Provide review and expert opinion in developing, revising, and maintaining core operating procedures and work instructions

Skills

Key technologies and capabilities for this role

Data ManagementClinical Data ManagementSAE ReconciliationExternal Data Vendor ReconciliationProject ManagementGlobal Trial ManagementDMPSOW Management

Questions & Answers

Common questions about this position

What education and experience are required for this role?

A Bachelor’s Degree or equivalent in health, clinical, biological or mathematical sciences, or related field is required, along with around 7 years of direct Data Management experience, including 5 or more years managing multiple global trials.

What are the key skills needed for the Senior Data Team Lead position?

Key skills include expert data management skills with advanced knowledge of DM processes like SAE reconciliation, excellent project management, communication, interpersonal, organizational, and problem-solving skills, plus knowledge of Medical Terminology, Pharmacology, and Good Clinical Practices.

Is this a remote position, or is there a location requirement?

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

What experience makes a strong candidate for this position?

Proven competence in managing delivery of multiple global trials through the full DM life-cycle (large trials of at least 1000 patients), handling complex customer negotiations independently, and leading process improvements stand out as key for strong candidates.

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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