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Senior Technical Designer Analyst, Clinical Data Management, remote, Europe

IQVIA

IQVIA™ Real-World Evidence (RWE) teams work with clients to help them collect and use real-world data to generate evidence to meet the needs of regulators, payers, providers and patients. Our unique approach is in the industry defines the way companies develop and apply real-world evidence for healthcare decision making.

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

The Senior Technical Designer Analyst will be responsible to oversee delivery and build of multiple studies in multiple platforms. A person in this role should have understanding of budget and finances for start up phase and will look into QIP/project finance for technical designing activities for all studies under purview. This role will work with the Data Management Lead, Validation Team Lead and Functional Managers. They may also communicate with sponsor as required. The Sr Technical Designer Analyst will be involved in library creation and must be an expert in at least 2 therapeutic areas.

REQUIRED EDUCATION KNOWLEDGE, SKILLS AND EXPERIENCE

  • Bachelor’s Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field
  • Minimum 3 years experience working as a Technical Database Designer within the Clinical Data Management
  • Demonstrable expertise in clinical data management and thorough knowledge of the Clinical Data Management 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 Clinical Data Management lifecycle
  • Previous experience of handling customer negotiations
  • Excellent communication, interpersonal, customer service, and teamwork skills

RESPONSIBILITIES 

  • Oversees timely delivery of study deliverables with quality
  • Interprets the study protocol
  • Designs and updates the eCRF
  • Creates and updates the Edit Specifications document
  • Generates specifications for EDC build components (e.g., System Settings)
  • Attends the eCRF Design Specification Meeting, Attends the Internal Design Review Meeting and Online Screen Review Meeting and supports DTL as needed.
  • May present at the Online Screen Review Meeting a visual design walk through
  • Facilitates the Internal Edit Check Specification Review Meeting and leads the discussions regarding the Edit Specifications document
  • Designs the database to collect Local Lab Reference Ranges (LLRR) data within the IBM Clinical Development or applicable database platform and ensures access Rights and Roles has appropriate access for Entry and Updates
  • Identifies and escalates potential Quality Issues to relevant parties with suggested solutions
  • Ensures the completion and documentation of all project-specific training, as well as staying current with required SOP reading for self and other TDs within the team
  • Reviews build timelines and provides inputs
  • Reviews QIP/ POP for own projects, identify out of scope activities if any and inform relevant parties
  • Communicates any project risks to the DTL, including any risk for missing a timeline in the Data Management Project Plan (MS Project)
  • Designs Library Source Study and Creates Edit specifications for source study
  • Mentors and trains new TDs in the team
  • Oversee budget and financial performance of multiple TD studies within scope and inform relevant parties as required
  • Act as an SME for TD role
  • Identifies areas for process improvements continuously. Proactively take part and contribute towards process improvement initiatives besides providing suggestions/ideas for continuous improvement of the process.

We are collaborative, intellectually curious, entrepreneurial, and constantly looking for opportunities to harness the value of Real-World Evidence in an evolving industry!

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IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

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Confirmed 17 hours ago. Posted 30+ days ago.

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