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Principal Technical Designer - Clinical Data Management (Home based in Europe) Real World Evidence

Employer
IQVIA
Location
Reading
Start date
21 Sep 2022
Closing date
6 Oct 2022

View more

Discipline
Data Management / Statistics
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

The vision of our Real World Evidence teams is to pioneer and lead with scientific and technical expertise, the generation and dissemination of high-quality Real World Evidence that make a true difference to patient lives, globally.  Come join us on this exciting journey!

You will have a unique opportunity to work with Real-World data and get an invaluable exposure to IQVIA’s cutting-edge technologies that facilitate the data flow between various sources. You will be equipped with the appropriate knowledge and training to manage site based as well as decentralized clinical data. At IQVIA, we are shaping the future of clinical data management while saving countless lives, globally.

We are a highly motivated global team, responsible for engaging with our clients to collect the right data with the right approach by using state-of-art technologies (EDC, eCOA, Direct To Patient).  

We have unique opportunities to be part of an innovative team, working with different data sources and continuously looking to enhance processes, so we are looking for the best talent to join us in this effort.

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

Purpose

The Principal Technical Designer 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 TD activities for all studies under purview. This role will work with the DTL, 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.

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.
- 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 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

- Oversee budget and financial performance of multiple TD studies within scope and inform relevant parties as required

- Acts as SME, mentoring and training new TDs in the team

- Completes post Go Live and post Mid Study Updates (MSU) quality checks and monthly quality checks

REQUIRED EDUCATION KNOWLEDGE, SKILLS AND EXPERIENCE

  • Bachelor’s Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field
  • Minimum 5 years experience working as a Principal Technical Designer within the Clinical Data Management
  • 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
  • Already possess the right to work in the hiring country

#LI-remote

#LI-robertapucciarini

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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