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!
THE ROLE
As a Senior Data Operations Programmer/Senior Clinical Data Coordinator, you will be play an important role in our FSP team - supporting one of our excellent US based pharmaceutical clients. The successful candidate will focus on answering queries on Veeva CDM and programming the backend dataset listings. The successful candidate will not be involved in the end-to-end programming.
Responsibilities
Employees may be required to perform some or all of the following...
- Perform senior review of database specification documents created by study teams, such as eCRF specifications and Data Review Convention specifications
- Build clinical study database CRF database screens per CRF/database specifications provided by the study team
- Create/Program edit checks, special action and derivations as per the Data Review Convention specifications
- Ensure non -eCRF technologies for data capture (e.g., ePRO, coding, IWRS/RTSM) are deployed as per requirements, including integrations with other systems, platforms or reporting environments with timelines for consumable data outlined
- Work closely with the study team to ensure all programming issues are resolved in a timely manner
- Complete study database updates as specified per database modification documents and procedures
- Trouble-shoot, solve study-building issues, and edit check-programming issues
- Configure and program additional system features, as required
- Create advanced custom programs as per Data Review Convention specifications as required
- Program reports and listings and contribute to the standardization of process and reports used for data review and analysis for external partners/vendors
- Perform senior review of critical document/deliverable (CDASH eCRFs, SDTM Annotation, SDTM datasets) to ensure Data Standards are used consistently and support creation of the eCRF
- 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
- Work as part of a study team to produce quality data· Take responsibility for data operations programming deliverables within reporting teams for complex studies
- Work independently as a database lead builder
- Support data operations study teams with archiving of study documentation: archiving trial databases
- Lead database build teams for projects of significant complexity to ensure quality and timely deliveries on Phastar projects or client studies
- 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
- Liaise with stakeholders to ensure successful project delivery
Qualifications
- Life Science degree, nursing qualification or equivalent experience
- Experience within a CRO setting or the pharmaceutical industry to have a good awareness of clinical trial issues, design and implementation, GCP and regulatory requirements
- Must have 2+ years of experience in Veeva CDB/CDM
- Must have experience using Medidata Rave
- CQL experience
- Inform DMW experience (desirable)
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!
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.
