Senior Data Manager at IQVIA

20124 Milano, Lombardia, Italy -

Full Time

Start Date

Immediate

Expiry Date

11 Sep, 25

Salary

0.0

Posted On

11 Jun, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Pharmaceutical Industry, Sensors, Wearables, Sdtm, Regulatory Requirements, Clinical Data Management, Data Standards

Industry

Pharmaceuticals

Description

GCD

On behalf of our Client a global pharmaceutical company, IQVIA is looking for a Senior Data Manager who can join an exciting working environment in a dynamic atmosphere.

JOB DESCRIPTION:

To ensure data management activity of the assigned studies are planned and executed according to project timelines, with highest standards in data integrity, data quality and under budget control
To ensure technologies/systems/data platforms needed for collecting and handling clinical data are properly developed, tested, fit for purpose and integrated
To support the definition of the strategy for data submission and lead the preparation of the data package to be submitted for drug approval
To represent Data Management in case of audit and Regulatory Inspection

REQUIREMENTS AND SKILLS:

University Degree in Scientific Disciplines
Minimum 5 years of experience in Clinical Data Management in CROs or Pharmaceutical Industry
Good knowledge of drug development processes
Good data management expertise
Solid knowledge of Good Clinical Data practices, GCP and regulatory requirements
Experience of clinical databases, electronic data capture (EDC) systems, Interactive Response System, ePatient Reported Outcome (ePRO), and wearables and sensors to collect data directly from patients
Good knowledge of Risk-Based approach
Knowledge of Real Word data sources and processes to collect/manage different type of sources (e.g. EHR data, data collected directly from patients, omics data, other secondary data)
In depth knowledge of Clinical Data Interchange Standards Consortium (CDISC) relating to data standards including Study Data Tabulation Model (SDTM) and Case Report Tabulation Data Definition Specification (Define.xml)
Advanced analytical and technical skills to interrogate and mine high volume of data from a variety of sources
Basic knowledge of Artificial Intelligence (AI)
English

Responsibilities

To plan and drive the conduct of all Data Management activities for the assigned studies ensuring consistency with Company standards and regulatory guidelines
To provide data management input and revision to study protocols
To design/review mock CRF/eCRF contents ensuring consistency with Study Protocol
To manage and guide providers, setting requirements, preparing the Request for Proposals and monitoring performance
To ensure all data collection systems for assigned studies are setup, tested and fit for purpose according to expectations and timelines
To review and approve CROs data management study documentation: Data Management Plan, database and data validation specifications, data transfer specifications, data reconciliation plan
To collaborate in the definition of Protocol Deviations Plan and monitoring of protocol deviations during the study conduction
To train or to provide consultancy to internal stakeholders on data management processes/standards/usage of tools (i.e. UAT, EDC tools, etc…)
To assist coding of medical terms and medical review
To ensure data cleaning is performed by CROs in according to data validation specifications by the revision of appropriate listings or data quality checks
To review database structure, annotated CRF and define.xml to ensure CDISC standards are properly implemented
To define and proactively manage risks with potential impact on study systems setup, study conduction, or reliability of study results, including contribution of definition of Quality Tolerance Limits and Key Risks Indicators
To lead the data quality evaluation, by the investigation of all clinical and operational data, evaluating trends, deviations, using visual analytics tools and ad hoc reports
To coordinate cross-functional data review meetings managing the collection of data issues, reporting of findings and communication of post-review status
To ensure database are locked according to regulatory requirements
To regular monitor data management costs of the assigned studies ensuring respect of budget
To ensure audit readiness and involvement in the CAPA process
To lead the preparation of data package for regulatory submission
To contribute to lessons learnt meeting at the end of the study, providing inputs to data handling procedures