Overview
Work as a data coordinator II on clinical and non-clinical trials; working as part of the study team, taking part in specifying, programming and User Acceptance Testing of eCRFs and edit checks; producing and reviewing sections of the Data Handling Manual. Contributing to clinical coding and processing of third party data, reviewing data listings and eCRFs and actioning queries in order to produce a clean database. Taking responsibility for all DM deliverables for non-complex studies. Excellent team work ethos, proactive at managing workload, willingness to help others and share skills
Client Specs:
Needs to have an understanding of the basics of programming in SQL, Python, R shiny and have the ability to join and manipulate data on cloud services. Jira experience is plus.
Huge benefit to have clinical experience (said they would be open to individuals with no industry) however individuals should have experience with blinded studies (know what is appropriate information to share or not)
Will require strong communication and project management skills as will be working closely with study team, data managers and data monitors.
Will need to write SOPs, learn and document as they go as no SOPs in place at the moment
Veeva CDB Experience is MUST
Responsibilities
Employees may be required to perform some or all of the following:· Performing QC of eCRF specification· Preparing eCRF UAT scripts and performing UAT according to scripts. Creating standard CDASH eCRFs from a library· Specifying edit checks in the Data Review Conventions. Preparing edit check UAT scripts and performing UAT according to scripts. Programming simple 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 and raising manual data queries within the study database· Entering normal ranges for local laboratory data· Generating key study metric reports including QC to ensure accuracy of content and flagging up any occurrences of untimely data entry, monitoring or data query responses as appropriate· Preparing draft templated and bespoke documents for the data handling manual and updating of documents (under supervision)· Reviewing coded data listings for consistency· Preparing draft documents for third party data, updating documents (under supervision) and reviewing reconciliation outputs· Reviewing safety data reconciliation outputs· Working as part of a study team to ensure allocated tasks are completed in a timely manner· Acting as the independent data manager for non-assigned studies and performing QC as specified in the study-specific QC plan. Inputting into the Database Lock Checklist and locking eCRFs· Exporting casebook PDFs and cataloguing for return to site· Working as part of a study team to produce quality data· Taking responsibility (under supervision) for data management aspects of study deliverables within reporting teams for non-complex deliveries. Preparing content of slides for Kick off Meetings· Working in a team to further data management initiatives· Working in a team to create articles, posters, presentations or publications· Filing and archiving own study documentation following instructions in supplied SOPs· Identifying any work-related obstacles and liaising with the Lead Data Manager to resolve these.· Taking responsibility (under supervision) for aspects of project deliverables within DM teams for non-complex deliveries on Phastar projects or client studies.· Managing own day-to-day workload to ensure all project goals are met · Prioritising quality in everything that you do. Ensure the principles in the PHASTAR checklist are followed rigorously · Helping network for potential recruits as and when required and representing the company at external events and conferences and presenting at conferences · Proactively identifying own areas for development/ improvement and sharing knowledge through attending and presenting and the Phastar forums · Helping others as and when required · Attending and assisting in development of internal training courses. Maintaining training record to accurately reflect course attendance · Implementing approaches that will result in error-free results · Understanding and working to the company SOPs. Implementing GCP standards
From Client:
Key Accountabilities:
- Configure data extraction and transformations in an individual contributor role across multiple data sources at the study level as defined by the Data Transfer Agreement and other specifications provided by Data Engineer
- Partner closely with internal/external stakeholders and data engineers in a collaborative manner
- Ensure accurate delivery of data format and data frequency with quality deliverables per specification
- Participate in the development, maintenance and training rendered by standards and other functions on transfer specs and best practices used by business
Additional Activities:
- Assists with quality review of above activities performed by a vendor, as needed.
- Adhere to SOPs for computer system validation and all GCP (Good Clinical Practice) regulations.
- Ensure compliance with own Learning Curricula, corporate and/or GxP requirements. Performs other duties as assigned within timelines
Qualifications
· Higher education qualification, nursing qualification or relevant experience· Some knowledge of the pharmaceutical industry with an awareness of clinical trial issues.· Familiarity with GCP and regulatory requirements· Experience of databases and data processing within a regulated environment
