Validation Manager

Overview

THE COMPANY

Phastar is a multiple award-winning global biometric Contract Research Organization (CRO) that is accredited as an outstanding company to work for by Best Companies. We partner with pharmaceutical, biotechnology and medical device organizations to provide the expertise and processes to manage and deliver on time, quality biostatistics, programming, data management and data science services. With offices across the UK, US, Germany, Denmark, Kenya, Australia, India, China and Japan, Phastar is the second largest specialized biometrics provider globally, and the largest in the UK.

Our unique approach to data analysis, “The Phastar Discipline”, has led us to build a reputation for outstanding quality. With this as our core focus, we’re looking for talented individuals who share our passion for quality and technical expertise to join our team.

WHY PHASTAR

Accredited as an outstanding company to work for, Phastar is committed to employee engagement, workplace satisfaction and ensuring a healthy work-life balance. We offer flexible working, part-time hours, involvement in developing company-wide initiatives, structured training and development plans, and a truly supportive, fun and friendly environment.

What’s more, when you join our team, Phastar will plant a tree in your honour, as one of our Environmental, Social and Governance (ESG) initiatives. So, not only would you get your dream job, you’ll also be helping to save the planet!

Responsibilities

• Lead and manage the validation process for data platform projects, ensuring compliance with regulatory standards and industry best practices
• Develop and execute validation plans, protocols, and reports for data sources including pharmacovigilance data from ARGUS, complaint systems, and other safety systems
• Create and manage test cases to ensure thorough testing of data transformations and integrations
• Collaborate with cross-functional teams including data engineers, data scientists, and pharmacovigilance experts to understand validation requirements and deliver effective solutions
• Monitor and document the validation activities, ensuring traceability and transparency throughout the process
• Identify and mitigate risks associated with data validation and transformation processes
• Ensure data quality, integrity, and security by implementing robust validation practices

Qualifications

• Bachelor’s degree in Computer Science, Information Technology, Life Sciences, or a related field
• Proven experience as a Validation Manager, preferably in the pharmaceutical industry
• Strong understanding of pharmacovigilance data and safety systems such as ARGUS
• Proficiency in developing and executing validation plans, protocols, and reports
• Experience with data validation, data transformations, and creating test cases
• Familiarity with regulatory requirements and industry standards for data validation in the pharmaceutical sector
• Excellent problem-solving skills and attention to detail
• Strong communication and collaboration skills

Preferred Qualifications:

• Master’s degree in a related field
• Certification in validation or quality assurance
• Experience with additional data tools and programming languages such as SQL, Python, or R
• Knowledge of data platforms and big data technologies

APPLY NOW

With the world’s eyes focused on clinical trial data, this is a fantastic time to join an award-winning specialized biometric CRO that is renowned for its technical expertise, outstanding quality and cutting-edge data science techniques. We offer flexible working, part-time hours, structured training and development plans, continuous learning opportunities, and a competitive salary and benefits package. We’re committed to ensuring our employees achieve a healthy work-life balance, within a supportive, fun and friendly working environment.

Should you feel that you have the right skill set and motivations for this position, please apply! Please note Candidates will need to be on-site in Copenhagen. We will happily speak to candidates willing to relocate from other countries.

Phastar is committed to the principles and practices of equal opportunities and to encouraging the establishment of a diverse workforce. It is our policy to employ individuals on the basis of their suitability for the work to be performed and their potential for development, regardless of age, sex, race, colour, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion, or belief. This includes creating a culture that fully reflects our commitment to equal opportunities for all.

Important notice to Employment businesses/Agencies

Phastar does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Phastar's Head of Talent Acquisition to obtain prior written authorization before referring any candidates to Phastar. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Phastar. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Phastar. Phastar shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.