Clinical Data Team Lead, Real World Evidence Latam

hace 2 semanas

Desde casa, Colombia IQVIA A tiempo completo

RWE Data Management is at the heart of our study delivery and responsible for ensuring high-quality study databases to help our customers generate real world evidence.

RWE Data Management is shaping and responding to the changing way real world research is conducted. This includes management of data quality, reliability and integrity by study design and purpose.

The team is adapting to the increase in data variety across EDC technologies, directly from patients, through decentralization of clinical research and modular studies with data capture from a blend of sources.


PURPOSE OF THE ROLE


As a
Clinical Data Team Lead
(DTL) you will manage end-to-end delivery of data management services for single/multi-service projects, ensuring quality deliverables on time and within budget, to meet client needs in the exciting and growing Real World Environment.

In addition, you will provide comprehensive data management expertise to the Clinical Data Management (CDM) team to provide high quality client driven data management products.

You will also provide leadership and vision to the team in the areas of project planning, execution and close-out.

REQUIRED EDUCATION KNOWLEDGE, SKILLS
AND EXPERIENCE

  • Bachelor's Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field
  • Minimum of 5 years direct Clinical Data Management experience, including 3 or more years as a Clinical Data Management project lead
  • Demonstrable expert CDM skills and thorough knowledge of the CDM processes (e.g., therapeutic area, SAE reconciliation, external data vendor reconciliation, management of local laboratory data and/or new technology)
  • Proven experience and competence in managing delivery of multiple studies/projects/programs through full CDM lifecycle
  • Previous experience of handling customer negotiations
  • Excellent communication, interpersonal, customer service, and teamwork skills
  • Fluency in English written and verbal

RESPONSIBILITIES

  • 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
  • Establish strong communications with DO team, functional leads, project managers, vendors, internal team members for resolution, and all other stakeholders
  • Work with functional manager(s) to ensure appropriate resources are assigned to meet project deliverables
  • Create and/or review and signoff on all data management plan (DMP) documents
  • Implement and track proactive quality management plans across multiple projects/program, and help timely resolution of problems
  • Serve as Subject Matter Expert
  • Provide leadership and expertise in a specific CDM task or technology
  • Train and mentor junior DTL staff in DM expertise. May coordinate the work of more junior DTL staff
  • Ensure service and quality meet agreed timelines and deliverables in contract Scope of Work (SOW)
  • Serve as Project Manager for single service DM projects, including financial tracking
  • Participate in and support RFP process
We are collaborative, intellectually curious, entrepreneurial, and constantly looking for opportunities to harness the value of Real-World Evidence in an evolving industry

**#LI-Remote #LI-RUBENALEJOS

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