Closing date for applications: 31 August 2020
MAC Clinical Research manages clinical trials for the pharmaceutical industry and we are seeking to appoint a Data Manager to join our biometrics team and make a positive impact in a world-leading Clinical Development Organisation. We are happy to be flexible with regards to location in the UK, so any of our clinical site locations may be considered.
This role would suit candidate with background or keen interest in life sciences, medicine or pharmacy.
The focus of this role is to provide Clinical Data Management support to Clinical Operations and/or study projects, Clinical Data Management and Biostatistics functions both internal to MAC and with associated Vendors.
Provide Clinical Data Management support to Clinical function, Clinical Data Management function and Biostatistics function participating in the review of Clinical research documents (e.g. Protocols, Case Report Forms, Reports and Statistical Analysis Plans).
Lead and support development and management of Biometrics documentation, including Data Management Plan (DMP), maintain DMP throughout lifecycle of study project and ensure DMP is followed according to study design and requirements.
Develop Case Report Form (CRF), electronic and/or paper as required; clinical trial data specifications, including eCRF design, User Requirements, validation checks and query logic.
Lead and support development of EDC database specification processes.
Develop and manage Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs.
Reconcile electronic data transfers from vendor to Sponsor as appropriate.
Develop test scripts and execution logs for User Acceptance Testing (UAT).
Coordination of UAT of eCRF build and validation documents, included but not limited to: edit check document, issue logs, UAT summary report.
Maintenance/tracking of EDC User Management and other Clinical databases across allocated Clinical trials, including but not limited to, compiling master user lists and activating/deactivating user accounts.
Lead and support training on study trial for EDC and create user guides.
Ensure clinical data maintained within EDC is of appropriate level of quality to Lock/Unlock and Freeze/Unfreeze as appropriate for statistical review, interim review, and/or Final Database Lock.
Lead and support defining and/or create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.
Co-ordinate the archiving of study databases and related documents.
Perform close-out audit, as specified, for closing of study trial in EDC or other Clinical Data Management tools.
Assist in reconciling AE/SAE data in Safety database(s) and/or other Clinical Data Management tools.
Assist and co-ordinate management of MedDRA and WHODRUG coding with internal stakeholders and external vendors.
Co-ordinate and communicate with vendors on a consistent basis with respect to project plans, eCRF development activities and other associated activities.
A working knowledge of clinical database applications, which may include (but not limited to) Medrio, Oracle Clinical, Medidata, SAS is desirable.
Experience with working on Phase I- IV study trials within the medical device and/or pharmaceutical industry (minimum of 1 year is desirable).
An awareness of Medical Dictionary Coding is desirable.
Excellent oral and written communication skills.
Self-motivated with the ability to work with minimal supervision.
Demonstrates a sound knowledge of ICH-GCP.
Strong planning, organisational and time management skills.
Strong analytical and problem-solving ability.
Understanding of the importance of study Protocols and the ability to interpret.
Understand how to capture required data.
Able to meet deadlines and escalate where appropriate.
Understanding and experience of eCRF data capture systems (desired).
Highly numerate with developed computer skills and logical, structured approach to assigned activities.
Competitive salary in keeping with pharmaceutical industry standards and will reflect experience
Free onsite parking
25 days annual leave plus bank holidays (increasing in increments to 30 days after 6 years long service)
Your birthday off work
Regular hours (including Christmas Day, Boxing Day and New Years Day off)
MAC Clinical Research invites applications from highly motivated candidates, with a desire to achieve their full potential. You will be working with an organisation that sees you as an investment and is keen for you to achieve your career aspirations.
Please note that if we receive a high volume of applications this date may be brought forwards.
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