Senior Clinical Data Co-ordinator

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

Work as a Senior Data Manager across multiple clinical studies; supporting data management activities; validating clinical data to excellent quality whilst adhering to deliverable timelines. Good knowledge of CDASH implementation guidelines; producing, reviewing and updating data handling manual; creating eCRF specifications, building and User Acceptance Testing of clinical databases. Mentoring Data Coordinators in their work, performing senior review of data management documentation and output deliveries, providing oversight and advising on best practices approach to clinical data processing. Creating and reviewing SOPs; tracking performance metrics; involvement in CAPA processes and ensuring implementation of quality processes. Act as a subject matter expert. Preparation of proposals and quotes and change orders for prospective and existing clients.

Responsibilities

• Preparing stable draft eCRF specification for database build. Finalising eCRF specification and obtaining approvals. Performing QC of eCRF specification. Creating project level or therapeutic area level standards

• Preparing eCRF UAT scripts and performing UAT according to scripts. Creating standard CDASH eCRFs from a library
• Creating study specific / complex eCRFs. Checking protocol requirements are met. Approving release of database. Performing senior review summary of UAT findings for complex studies
• Specifying edit checks and performing senior review of the Data Review Conventions. Preparing edit check UAT scripts and performing UAT according to scripts. Programming study specific / complex edit checks
• Producing and reviewing data listings for data anomalies and performing sight review of eCRF data
• Reviewing edit check outputs and actioning as appropriate. Actioning data query responses. Raising manual data queries within the study database. Resolving issues arising with data queries
• Reviewing and entering normal ranges for local laboratory data, managing annual updates and raising issues with sites on local laboratory data
• Defining and generating key study metric reports for periodic review by client, including QC. Overseeing progress of data entry by sites, monitoring by CRAs and responses to data queries
• Producing key study metric reports and KRIs for RBM approach. Reporting monitoring and mitigating actions in the issues tracker
• Preparing, performing senior review / QC and updating documents for the data handling manual. Performing senior review of data handling manual and giving advice for complex study procedures. Compiling all documents in the DHM and obtaining client approval
• Assigning dictionary codes to medical terms, performing QC of coded terms and reviewing coded data listings for consistency. Liaising with study Medical Physician to resolve coding issues
• Preparing documents for third party data, performing senior review, QC and update of those documents. Establishing test and live data transfer processes through liaison with third party vendors. Liaising with third party vendors and / or client for resolution of process or contract issues
• Reviewing reconciliation outputs and resolving data issues with client and / or third party vendors

Qualifications

• Life Science degree, nursing qualification or equivalent experience
• Experience within the pharmaceutical industry to have a good awareness of clinical trial issues, design and implementation, GCP and regulatory requirements
• Good experience of data management software systems and coding dictionaries including MedDRA and WHODrug
• Extensive experience of leading data processing activities within a regulated environment

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.