I am working on behalf of a Global Pharmaceutical Company in Germany for the position of a Senior Data management Programmer. Our client is very keen to speak to those with direct experience as either an SAS Programmer or Data Management Programmer within either Pharma or CRO. Previous experience within a Clinical Data Management Group with hands on Programming and additionally loading laboratory Data in phases I to III would be advantages.  

Key Responsibilities: 

Performing Data Management programming and tool support

o Setup of the clinical study database in close cooperation with the EDC database developer and data manager.
o Setup of Data Management tools for study conduct (e.g. edit checks, validity tool, coding call, SAE etc.)
o Full study programming and validation support
o Develop programs for transformation of the acquisition data from the EDC system \ data management system to the 
o Operational Acquisition Database (OAD) to meet CLIENT project standards.

Implementing Strategy
o Support programming functional projects and initiatives within Project and Clinical Data Management

Developing People
o Adhere to clear performance targets 
o Most tasks are done under supervision of higher level SAS programmers to develop skill set
o Foster an effective and cohesive team environment among Clinical Data Centre staff members

Managing Key Interfaces
o Ensure close collaboration and communication with partners outside of data management, e.g., Statistics, Study  Management, Monitoring, Medical Writing and CROs specifically within all assigned studies.

Ensuring Compliance
o Ensure 21 CFR Part 11 compliance for all systems used in Data Management
o Ensure rapid access to all data from clinical trials at any time to meet the requirements of the EU Clinical Trials 

Directive, independent medical review bodies (and pending FDA requirements) for all assigned studies 
o Ensure compliance with all relevant SOPs, GxP and ICH guidelines, as well as with legal and ethical standards

Professional/Technical Role Expectations:

Technical Expertise
o Building and Maintaining fundamental knowledge in own discipline and broaden skills
o Applying and Anticipating knowledge and skills to a variety of standard activities

Customer/Business Orientation
o Customer Response to non-standard requests from customers; investigate with assistance from others as needed
o Business Understanding the key business drivers; use this knowledge in own work
o Financial Responsibility control costs related to own work

Creating and Delivering Solutions
o Problem Solving a range of problems in straightforward situations; analyze possible solutions and assesses each using standard procedures
o Planning and Organizing own work to meet deadlines

Working Relationships
o Communicating, Negotiating and Influencing information and persuade others in straightforward situations
o Teamwork Apply team effectiveness skills; contribute to the achievement of team goals

Fluency in English: Essential

Qualifications/Education:

Bachelor’s degree (or equivalent) Preferred

You may leave the list at any time by sending the command

SIGNOFF allstat

to [log in to unmask], leaving the subject line blank.