Clinical Data Management Lead, home-based

Visa Hunt; Poland; On-site; PLN 157,000 - 394,000; Full time

Job summary

IQVIA is a leading global provider of clinical research services., IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. The role focuses on data management leadership across large, global trials, managing DM life-cycle and stakeholder negotiations.

Qualifications

• Experience leading multiple global data management studies through full DM lifecycle.
• Expert DM knowledge: SAE reconciliation, external data vendor coordination.
• Proven, independent negotiation and bid defense experience.
• Strong understanding of regulatory guidelines and clinical data processes.

Responsibilities

• Serve as primary contact for data management deliverables and timelines.
• Lead and support DTLs on large global studies and programs.
• Manage DM service delivery with process and technical expertise.
• Negotiate timelines, scope and resources with customers.
• Meet milestones with Data Operations team; ensure quality deliverables.
• Sign-off on data management plans and review SOPs/work instructions.
• Provide SME leadership on DM tasks or technologies and manage SOW/budget.

Skills

Data management

Project management

Negotiation

Communication

Teamwork

Problem solving

Independent work

Regulatory knowledge

Education

Bachelor’s degree in health sciences

Job description

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

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)
• 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
• 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

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is zł157,400.00 - zł394,100.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.