Data Quality Manager

Location
Bochum
Salary
Competitive
Posted
11 Jan 2019
Closes
08 Feb 2019
Ref
synexus/TP/25546/1627
Discipline
Quality, QA / QC
Contract Type
Contract

Are you looking to advance your career in the clinical trial space?

Do you want to work for a leading multinational organisation, renown throughout the industry for its meteoric rise to success and dependability to deliver on global contracts across multiple therapeutic areas and phases?

Are you looking to play an integral role in the future of medicine across the globe?

We are currently looking to recruit a Data Quality Manager for our dedicated research site in Bochum.

This is a 12 month temporary contract and will be responsible for driving operational quality and process improvement initiatives to ensure long term business success.

It will involve supporting the site’s Quality Management System, resolving CAPAs, the preparation for internal / external audits and operational compliance checks.

The Data Quality Manager will also lead & develop a team of data coordinators on the site, training and supporting them to improve capability.

Package description

Attractive salary + benefits

30 day paid vacation

Interesting & varied role

Detailed training & development

Work with a motivated and reliable team

Free beverages & fruit!

Main responsibilities

Key roles and responsibilities of a Data Quality Manager are as follows -

Operational Quality Compliance

  • Prepare individual/site Operational Compliance plans and perform quarterly operational compliance check activities
  • Prepare associated reports and follow up on quality issues from all sources and related CAPAs
  • Perform regular quality control and oversee that quality of data is accurate, on time and adhere to Synexus SOPs, COP’s standards, GCPs, Local Regulatory and protocol
  • Validate and check quality of essential documents, participant files and site study data ensuring accuracy of data entered and source documents.
  • Report and follow up with Site Director / Site Manager and operational staff on the status of quality activities and projects
  • Develop, maintain and produce a dashboard for tracking patients, flow of CRFs and queries ensuring that this is provided in a timely manner.
  • Lead Data Coordinator on projects and deliver projects on time and to the client’s satisfaction.

Training and Development                        

  • Check Quality and Training processes to ensure appropriate timelines are met
  • Identify gaps in processes to improve clinical performance
  • Provide guidance on functional GCP, and other compliance and quality related topics, as required to improve quality and expertise within the operation of the regional research centres

Safety and Risk Management   

  • CAPA reporting and basic root cause analyses knowledge.
  • Responsible for audit preparation and ensure audit readiness of site files
  • Responsible for maintenance of studies status trackers if lead DC on a study
  • Identify trends in data queries
  • Support Synexus QA with regard to notifications, preparations and facilitation of client audit and regulatory inspections, investigations of quality issues and tracking and follow up of local CAPA status

Leadership         

  • Line management of the Data Coordinators Team, set goals and objectives and measure their performance. Deliver effective performance, talent and career management processes for the DC team
  • Prioritize daily workload for optimum quality and productivity in the DC team
  • Manage underperformance proactively in line with company policy

Compliance, Regulations and Governance          

  • Ensure quality and patient safety are at the forefront of all activities through review and interpretations of audit reports, quality statistics and operating procedure robustness and follow-up on Quality Issues.
  • Ensure that there is a compliant, consistent  working environment through robust implementation and oversight of  standard operating procedures and work instructions

Ideal candidate

To be considered for this opportunity you will need the following skills and experience:

  • Relevant work experience with data and/or quality management
  • Industry knowledge of quality compliance within a regulated industry
  • Team leadership experience, the ability to engage, develop and lead people
  • Proven knowledge of SOPs, GCPs and local/international regulations
  • Ability to analyze data, share information and make recommendations for improvements
  • Appropriate MS Office skills, EDC, eCRF and possibly IT/SQL skills but not essential
  • German & English language skills
  • Proficient in decision making, problem-solving, prioritising, critical thinking and analytical skills

If you are interested please apply ASAP

About The Company

“Our Dedicated Research Sites are where high quality staff engagement and top of the class facilities meet with the client expectation for fast enrolment and delivery."

Dr Radoslaw Janiak (President & COO)

Our success is based on a simple, but crucial, principle. We place the patient at the heart of everything we do. Synexus is a world class Site Network Organisation with global expertise spanning patient recruitment, trial planning, management and patient retention.

We recruit and retain more engaged patients, at fewer sites, and in less time than traditional centres, enhancing the quality and efficiency of our customers’ drug development programmes.

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