Our client, a young science driven biopharma company with early stage product development pipeline, due to rapid expansion they now have approval for a permanent Clinical Data Manager (CDM) role for their standalone role. Reporting to the Director of Clinical Operations, the CDM will be a member of the Clinical Operations team with Sponsor company, working closely with the Clinical Project Managers and Clinical Sciences team.
The CDM will work closely with their CRO counterpart to ensure the data management (DM) process on each new project is setup, quality controlled, and managed robustly, in line with ICH / GCP guidelines, company SOPs and all applicable regulations.
The CDM will be responsible for providing data outputs to all ongoing projects, to maintain oversight of dataflow and support with issue resolution. The CDM is directly responsible for performing data checks/reconciliations, and presentation of data tor Senior Management.
Person fit: Ideal candidate will be a Clinical Data Management professional, who is highly motivated, self-driven and adaptable to changing priorities, working in a fast-paced dynamic environment.
- Serve as the Lead CDM and primary contact responsible for overseeing day-to-day DM activities from study start-up through final database lock, including, but not limited to:
- Creation and maintenance of the Data Management Plan
- Development and design of Case Report Forms (CRFs)
- Develop Database Build Specifications and coordinate database build and testing activities with database programmers.
- Define and test edit checks.
- Perform data review and query generation/resolution.
- Track study progress and issue periodic status reports
- Process/reconcile electronic data received from other data sources, e.g., CIMS, Safety database, labs, IRT
- Oversee database lock and transfer process.
- Ensure the data cleaning and transfer processes on each new project are setup, quality controlled, and managed robustly.
- Attend and participate in meetings as requested.
- Act as the escalation point and point of contact for the Sponsor for all DM activities.
- Perform QC on all aspects of work related to DM activities to ensure that data quality and integrity is maintained.
- Work with the CRO counterpart to run and perform routine ad hoc data cleaning checks on data, identify errors, inconsistencies, and discrepant data for resolution.
- Track outstanding issues and follow-up until resolution.
- Maintain, organize, complete, and update study documentation, including reviewing Data Transfer Agreements and Image Transfer Agreements and configure associated extracts for data transfer output.
- Write project-specific transfer work instructions and perform test/production transfers.
- Perform UAT activities.
- Assist in standardising and documenting DM procedures.
- Participate/lead internal sponsor meetings as required, working directly with the assigned project manager and team to provide DM support.
- Ensure approved study documentation is maintained and properly stored in the trial master files as per the Sponsor’s filing structure.
- Manage project resources per budget and within expected timeframes.
- Work alongside the Quality department to create applicable Standard Operating Procedures (SOPs) pertaining to DM activities.
- Develop and maintain effective working relationships with all team members.
- Ensure the maintenance, tracking, and accuracy of operational data and milestones and facilitates the reporting of these to the Senior Management team.
- Primary day-to-day contact for DM-related activities to ensure delivery against contracted scope of work.
- Develop or provide operational input to the development of study documents, including study protocols, case report forms, and project plans.
- Oversee the collation of feedback on study level documentation and ensure appropriate updates are made.
Requirements for this role:
- Bachelor's degree in Computer Science, Life Sciences, or related field preferred.
- 4+ years' experience of working in Data Management within the Pharmaceutical, Biotech or CRO industry in Phase I, II and III clinical studies working to ICH / GCP guidelines and regulatory requirements.
- Strong IT skills (working within cloud-based database systems desirable) and demonstrate experience of working with a variety of data formats.
- Experience working with Microsoft Office tools in particular Excel.
- Ability to learn other computer systems, including databases.
- Demonstrated knowledge of GCPs, ICH guidelines, CFR Part 11 and computer systems validation.
- Demonstrates ability to build and maintain effective relationships with others and establish collaborative partnerships with internal and external stakeholders.
- Strong working knowledge of MS Office and Outlook.
- Excellent communication, organization and decision-making skills
- Flexible in reacting to changing priorities in projects without compromising timelines and/or quality.
- GCP certification is considered a bonus.
For further details, contact Larry on +353 1-2302400 / email@example.com
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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