Freelance Clinical Data Manager - Europe
Location | Europe |
Discipline: | Biometrics |
Job type: | Contract |
Salary: | £€ DOE |
Contact name: | Harry Henson |
Contact email: | harry.henson@rbwconsulting.com |
Contact phone: | +44 (0)1293 364 092 |
Job ref: | 33177 |
Published: | 4 months ago |
Expiry date: | 16 Jul 2024 11:59 |
Startdate: | ASAP |
RBW Consulting are partnered with one of our regular CRO partners, a mid sized CRO with HQs in both the US and Europe, in their search for a Freelance Clinical Data Manager to be based remote, anywhere in Europe.
This role is 1 FTE, and a contract until the end of 2024, dealing with some urgent projects within the organisation.
The Freelance Clinical Data Manager will be responsible for and manage all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing.
Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs.
Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
May perform quality control of data entry
Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed.
Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
May assist in building clinical databases
Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications
Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.
Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.
Review and query clinical trial data according to the Data Management Plan
Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
Run patient and study level status and metric reporting
Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
Coordinate SAE/AE reconciliation
Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables
May assist with SAS programming and quality control of SAS programs used in the Data Management department
Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project
Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
May attend strategy meetings, bid defence prep meetings, bid defences, capability presentations, potential client engagement meetings
May review Request for Proposals (RFP), proposals, provide project estimates
Provide leadership for cross-functional and organization-wide initiatives, where applicable
Trains and ensures that all data management project team members have been sufficiently trained
Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues
May present software demonstrations/trainings, department/company training sessions, present at project meetings
Please apply here and Harry Henson will be in contact to discuss your application further!