Senior Clinical Data Engineer with Oncology exp.(FSP) - Romania, South Africa, Hungary

Parexel International Corporation

Multiple Locations

Job Purpose: 

The Functional Service Provider (FSP) division of Parexel is seeking a candidate for a Senior Clinical Engineer. The Senior Clinical Data Engineer provides technical expertise for the conduct of clinical trials and works to support various activities related to electronic data, and/or the applications/systems within eClinical technologies. General areas of responsibility will include development of macros/on-demand reports for clinical teams to execute throughout the life of studies. The Senior CDE will support development of macros to improve external vendor data reconciliation. Position responsibilities may also include: Aggregating applicable data from all sources and devices, managing external data, programming offline listings, trend analysis, data review, data transfers. All tasks should be performed in accordance with corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements.

Key Accountabilities:

Manage Electronic Data & Technology 

Lead and implement the setup of Data Receipt Agreements with vendors by working with cross functional teams.

Programming and setup of Import procedures to allow the ingestion of data either using SAS or alternative technology (e.g., “Workbench”).

Programming of reconciliation checks to ensure appropriate transfer of data. 

Programming of offline listings and custom reports to allow better insights to all external data. 

Aggrege data across all sources.

Handling Missing Values, reading raw data files, creating data structures, handling programming errors, accessing, and managing data, appending and concatenating SAS datasets. 

Review of data using created outputs with aim of providing insights to study teams and clients. 

Coordinate and lead a programming team to successful completion of a study within given timelines and budget.

Manage the deployment of the DM technology used for creation of offline listings (e.g., Workbench, SAS or R).  

Support Projects    

Assist in providing technical solutions to internal or external/client enquires. 

Ensure adherence to service levels agreements with regard to the turnaround time from the point when specifications are finalized.

Support Initiatives 

Participate in the creation of standards, either through tools (e.g. SAS Macros), libraries or processes, as required for GDO to ensure efficient, effective and optimal processes. 

Develop, improve and implement project specific tools, including, but not limited to standard project directories and subdirectories, document file names and status reports that result in improved efficiencies.

Assist in providing technical solutions to external client inquires. 

Account Leadership    

Will work directly with client data management leadership, in client systems, following client processes as an extension of the client.

Ideal candidate will possess:

Bachelor’s degree in a relevant discipline.

Three years of data management experience in clinical research industry.

Two years of oncology and clinical vendor data reconciliation experience.

RAVE EDC and SAS programming experience.

J-review experience preferred but not required. 

Knowledge of SOPs/Guidelines/Work Instructions/System Life Cycle methodologies, ICHGCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application. 

Written and oral fluency in English.

Strong ability to lead and collaborate with global teams and work independently.  Motivate/guide virtual teams across multiple time zones and cultures to work effectively.

Strong interpersonal, oral and written communication skills using concise phrasing tailored for the audience with a diplomatic approach.

A flexible attitude with respect to work assignments and new learning; ability to adjust rapidly to changing environments.

Customer focus to interact professionally and respectfully within Parexel and all external colleagues to build rapport and trust.

Proficient presentation skills.

Good business awareness/business development skills (including financial awareness). 


2022-11-17 00:05:20

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