Clinical Data Management Lead

2 days ago

Durban, KwaZulu-Natal, South Africa Iqvia Full time
Job Overview

We are seeking a highly skilled Clinical Data Management Lead to join our team. In this role, you will be responsible for managing single and multi-service projects, ensuring quality deliverables on time and to the customer's satisfaction.

You will provide expert skills as part of a Clinical Data Management (CDM) team to provide quality data that meet customer needs. Additionally, you will provide leadership to the team in the area of coding, project planning and execution, financial management, communication and milestone tracking.

This is an exciting opportunity to work with a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.

Key Responsibilities
  • Serve as an account lead, or internal or external point of contact on standalone coding studies or accounts.
  • Manage the customer relationship for the project team including active participation in coding related customer negotiation on timeline, budgetary and other issues.
  • Provide leadership and senior support to lead coders on one or more large global studies.
  • Manage the relationship with a customer on a DM site level.
  • Serve independently as a Lead Data Coder and / or Coding reviewer for one or more projects.
  • May serve as a DOC or DTL for one or more projects.
  • Perform comprehensive quality control procedures.
  • Perform Serious Adverse Event (SAE) reconciliation activities.
  • Collaborate with customers and develop solutions and action plans for issues, escalations and road blocks.
  • Proactively identify, solve quality issues and deliver projects as per agreed timeline.
  • Identify and provide due diligence for out of scope activity.
  • Manage resource capacity for the project team.
  • Mentor other team members in training and developing coding expertise.
  • Independently bring project solutions to the Coding and CDM team.
  • Identify and implement processes and quality improvement initiatives in the DM and coding function.
  • Develop and implement best practices in the team.
  • Manage the development and implementation of new technologies.
  • Demonstrate scientific and research temperament by presenting at, or participating in local and international forums.
  • Responsible for identifying and implementing process improvements using established methods (principles of lean and six sigma) in collaboration with experts.
  • Provide review and expert opinion in developing, revising, and maintaining standard core operating procedures and work instructions.
  • Perform other duties as directed by the DOC, DTL or Manager, or meet objectives as assigned.
  • Develop and maintain good communications and working relationships with the CDM team and client stakeholders.
Requirements
  • High School Diploma or equivalent Pharmacy, dental, medical, nursing, life sciences or related field qualification or educational equivalent.
  • 7 years relevant experience in clinical trials within a similar function, including proven competence in managing the delivery of coding or / and other data management processes for multiple global projects, also including experience in handling complex customer negotiations and bid defense meetings.
  • Excellent knowledge of Medical Dictionaries used for coding (e.g. MedDRA, WHO-ART).
  • Excellent knowledge of Medical Terminology, Pharmacology, Anatomy, and Physiology required for many tasks.
  • Advanced knowledge of data management processes and systems and advanced ability to apply this knowledge in practice.
  • Excellent understanding of clinical drug development process (detail oriented).
  • Outstanding communication and organizational skills.
  • Proven leadership skills.
  • Good project management skills related to all phases of clinical studies.
  • Excellent knowledge of operating procedures and work instructions and the ability to apply them in practice.
  • Excellent English written and oral communication skills.
  • Ability to work on computer systems with ease and good working knowledge of computer programs.
  • Ability to exercise excellent attention to detail and act independently with the initiative required to resolve problems.
  • Ability to establish and maintain effective working relationships with co-workers and managers.
  • Comprehensive understanding of financial management concepts and able to interpret financial information.
  • Able to present information effectively to individuals and groups.
  • Able to make independent decisions within scope of authority and considers the impact of decisions on other groups and people.
  • Able to motivate and lead teams to reach defined objectives.
  • Effective team management skills including conflict resolution, delegation, and change management.
  • Excellent interpersonal skills.
  • Able to establish trust and collaborative relationships with customers.

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