Manage single and multiservice projects ensuring quality deliverables on time within budget and to the customer's satisfaction; provide expert skills as part of a Clinical Data Management (CDM) team to deliver quality data that meets customer needs; provide leadership in coding project planning, financial management, communication, and milestone tracking; viewed as an expert in coding of clinical data; may perform roles such as Data Operations Coordinator (DOC), Data Team Lead (DTL), and customer site lead, or manage and deliver a program of studies for a customer.
Essential Functions
- Serve as an account lead or internal/external point of contact on standalone coding studies or accounts.
- Manage customer relationships, including active participation in negotiations related to timelines, budgets, and other issues.
- Provide leadership and support to lead coders on large global studies.
- Manage relationships with customers at the DM site level.
- Serve as a Lead Data Coder and/or Coding reviewer for projects.
- May serve as a DOC or DTL for projects.
- Perform comprehensive quality control procedures.
- Conduct Serious Adverse Event (SAE) reconciliation activities.
- Collaborate with customers to develop solutions and action plans for issues, escalations, and roadblocks.
- Proactively identify and resolve quality issues to deliver projects on time.
- Identify out-of-scope activities and perform due diligence.
- Manage resource capacity for the project team.
- Mentor team members in training and development of coding expertise.
- Bring project solutions independently to the Coding and CDM team.
- Identify and implement process and quality improvement initiatives in DM and coding functions.
- Develop and implement best practices within the team.
- Manage the development and deployment of new technologies.
- Present at or participate in local and international forums to demonstrate scientific and research expertise.
- Identify and implement process improvements using lean and six sigma principles in collaboration with experts.
- Review and provide expert opinions for developing, revising, and maintaining SOPs and work instructions.
- Perform other duties as directed or as needed to meet objectives.
- Maintain good communication and relationships with the CDM team and client stakeholders.
Qualifications
- High School Diploma or equivalent in pharmacy, dental, medical, nursing, life sciences, or related field.
- 7+ years relevant experience in clinical trials, managing coding or data management processes for multiple global projects, including complex negotiations and bid defenses.
- Excellent knowledge of medical coding dictionaries (e.g., MedDRA, WHODD, ICD9).
- Strong understanding of medical terminology, pharmacology, anatomy, and physiology.
- Advanced knowledge of data management systems and processes.
- Deep understanding of the clinical drug development process.
- Outstanding communication, organizational, and leadership skills.
- Proven project management skills across all phases of clinical studies.
- Excellent knowledge of SOPs and work instructions, with practical application skills.
- Excellent English communication skills.
- Proficiency with computer systems and software.
- Attention to detail and ability to work independently to resolve problems.
- Effective at building relationships with team members and clients.
- Understanding of financial management concepts and ability to interpret financial data.
- Ability to present information effectively and make independent decisions.
- Motivational and team leadership skills, including conflict resolution and change management.
- Excellent interpersonal skills and ability to establish trust with customers.
This role is not eligible for UK visa sponsorship.
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create connections to accelerate the development and commercialization of medical treatments to improve patient outcomes and population health worldwide. Learn more at our website.
Required Experience: Senior IC
Key Skills: Collection and Recovery, Banking, ABAP, Insulation, Investment Management, Client Services