Senior Data Operations Analyst

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

RESPONSIBILITIES:

• Provide expert advice for Data Operations project innovation - report progress, risks and issues to senior management
• Lead the implementation, accreditation and validation tasks for new software required to conduct Data Operations tasks
• Perform risk and impact assessment of new releases to software and provide input into change management plans
• Receive and process feedback from project teams.
• Lead the development and maintenance of CDASH compliant global eCRF libraries ensuring efficient mapping to current SDTM standards
• Lead the development, update and retiral of CDASH compliant therapeutic area eCRF libraries ensuring efficient mapping to current SDTM standards
• Participate in study specific eCRF programming strategy meeting at study set up
• Perform senior review of eCRF specifications created by the study teams
• Build clinical study database CRF database screens per CRF/database specifications provided by the study team
• Complete study database updates as specified per database modification documents and procedures
• Trouble-shoot, solve study-building issues
• Work independently as a database lead builder
• Work closely with the study team to ensure all programming issues are resolved in a timely manner
• Configure and program additional system features
• Take responsibility for data operations programming deliverables within reporting teams for complex studies
• Technical support for lab administration tools
• Technical support for autoencoding tools
• Support data operations study teams with archiving of study documentation: archiving trial databases

Qualifications

SKILLS AND EXPERIENCE REQUIRED:

• Certified Medidata Rave builder in EDC and Coder
• Proven ability to design Screens & program Edits and Custom Functions in Medidata RAVE EDC
• Design and program Custom Functions in Medidata RAVE EDC (Ideally accredited in Custom Function and use of C#)
• University/college degree (life science, computer science, programming, pharmacy or related subject preferred), or certification in a related profession from an appropriately accredited institution (e.g., nursing certification, computer science, medical or laboratory technology)

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 that we are considering candidates located anywhere in the UK as this role can be carried out remotely.

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.