Lead Data Manager

2 settimane fa

Milano, Italia IQVIA A tempo pieno

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

**JOB DESCRIPTION**:

- To lead data management activities of the assigned project(s) ensuring data strategy and data governance are properly implemented across all clinical studies
- To act as technical leader supporting team members, ensuring consistent data management approach across studies, and representing data management at project level
- To ensure technologies/systems/data platform needed for collecting and handling clinical data are properly developed, tested, fit for purpose and integrated
- To ensure data management activity of the assigned projects are planned and executed according to project timelines, with highest standards in data integrity and data quality and under budget control
- To define 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

**RESPONSIBILITIES**:

- To plans and drive the conduct of all Data Management activities for the assigned project(s) ensuring consistent approach across studies
- To manage high complex studies and/or support specific activities of studies managed by other data managers or consultants
- To provide technical tutoring and supervise data managers and/or contractors assigned to clinical studies of the project by conducting regular reviews of activity status
- To manage and guide providers, setting requirements, preparing or reviewing Request for Proposals and monitoring performance
- To regular monitor data management costs of the assigned studies ensuring respect of budget
- To define and proactively manage risks with potential impact on study systems setup, study conduction, or reliability of study results
- To ensure all data collection systems for assigned projects are setup, tested and fit for purpose according to expectations and timelines
- 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 define the strategy and lead the preparation of data package for regulatory submission
- To represent data management for auditing / regulatory inspection

**REQUIREMENTS AND SKILLS**:

- University Degree in Scientific Disciplines
- Minimum 10 years of experience in Clinical Data Management in CROs or Pharmaceutical Industry
- Solid knowledge of drug development processes
- Strong data management expertise
- Excellent knowledge of Good Clinical Data practices, GCP and regulatory requirements
- Experience of clinical databases, electronic data capture (EDC) systems, wearables and sensors to collect data directly from patients
- Excellent 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)

**TYPE OF CONTRACT**:
Permanent contract

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