ProClinical is seeking a Project Data Manager for a clinical-stage drug discovery and development company advancing innovative therapies to significantly advance the current standard of treatment for serious unmet medical needs. This Project Data Manager role is responsible for handling detailed Data Management issues for all phases of clinical trials including oversight of CRO data management activities. This is a permanent role based in Oxford, UK.
- Provide oversight to CRO data management activities.
- Aid in the development of the Scope of Work (SOW) for data management deliverables and expected timelines
- Work closely with Clinical Trial Managers, develop timelines and ensure data management objectives are met
- Provide data management input for Risk Based Monitoring activities
- Develop, define, and manage data management related timelines, deliverables, and performance metrics with the study team and external vendors. Communicate expectations and deliverables in terms of study milestones
- Review draft study protocol for consistency and assess the implications on data management activities (e.g., CRF design, identifying vendor data [PK, Labs, MRI, etc.])
- Participate in study planning and initiate data management start up activities (e.g eCRF design, edit check specification, user acceptance testing) in conjunction with the clinical study team
- Develop and revise Data Management Plan ensuring input and approval from relevant functions. The plan includes, but is not limited to: Quality Control Plan, Serious Adverse Event Guidelines, Edit Check document, and Coding Guidelines
- Ensure the databases are designed in a standard, accurate, complete and consistent format conducive to analysis by working with the lead CRO data manager
- Ensure all activities in the Data Management Plan either by "hands-on" activity or through coordination with the CRO are completed
- Monitor data transferred from external vendors into the clinical database for integrity, clarity, and consistency; ensure application of a consistent process for transfer and quality check.
- Analyse the results from quality control activities (e.g., metrics, discrepancy/ query analysis, data audits) to ensure that data quality is not put at risk and apply remediation activities if/when required
- Critically assess and forecast clinical trial progress - through metrics, timeline management, etc. - so that remediation activities can be applied if/when required
- Perform final checks for database consistency and completeness prior to database freeze and lock and ensure the subsequent database lock activities are completed (e.g., PK data loaded and other electronic data that may un-blind the study are loaded)
Skills and Requirements:
- A degree in a scientific discipline or equivalent
- Minimum of 6 years’ experience (3 years as a lead) as a Data Manager in a CRO or Pharmaceutical/Biotech company, and experience as a lead CDM managing studies from preparation through close-out (including data management activities related to study conduct, study completion, and archiving of study materials) including management of outsourced CDM activities.
- Ability to work independently with minimal supervision and excellent written and oral communication skills are required.
- Familiarity with coding of medications, medical conditions, and AEs/SAEs is necessary.
- Sound knowledge of all relevant regulations including GCP as well as general knowledge of industry practices and standards (CDISC, SDTM) is essential.
- Good understanding of clinical trial methodology, clinical trial data and databases.
- A team player with a keen eye for detail and quality focused
- In-depth knowledge of Data Management procedures, process, and best practices
- Excellent interpersonal and communication skills, self-motivated, clear thinker.
- Ability to plan and organise work, to work under pressure with high attention to detail, to independently evaluate and communicate development needs
- A dynamic self-starter in tune with the opportunities and constraints of working in a small company.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Sam Walker on +44 203 8569 336 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.