Clinical Data Manager/Programmer

Our Company Ergomed was founded in 1997 by Dr Miroslav Reljanovic. In 2014 the company was added to the LSE and became a PLC. Ergomed is a full service CRO with offices across the globe. Ergomed’s other divisions also offer co-development services and a specialist pharmacovigilance consultancy. The CRO part of the business employs around 300 people whilst the entire group numbers around 800. Ergomed believes its approach to clinical trials is differentiated from that of other providers by its innovative Study Site Management model and the use of Study Physician Teams, resulting in a close relationship between Ergomed plc and the investigational sites involved in clinical trials. Ergomed works with some of the largest pharmaceutical companies to many small and mid sized organisations. It has successfully managed clinical development from phase 1 through to late phase programs. Our therapeutic experience includes many successful Oncology, neuroscience pain, and rare disease trials as well as many trials in other indications.

Data Manager Position summary: Data Managers (DM) within the ERGOMED Data Management (DM) department are responsible for operational activities of the DM part of a project, and takes an active role in creating, updating and filing project-related documentation. In close cooperation with the Project manager (PM) the DM is involved in communication with the sponsor. The Data Manager within ERGOMED DM represents a position under direction of the Head of Data Management.

Duties and responsibilities of the Data Manager are:

• Provide oversight and coordination of all DM activities in a project.
• Coordinate the Data Entry Clerks (DEC) and Database Developers (DBD) allocated to a project.
• Development of Case Report Forms (CRFs) for data collection.
• Creation, update and filing of project-related documentation (e.g. Data Management plan (DMP), Data Validation Plan (DVP), Data Entry Guideline, Database Specification Document (DBSD), Database Report (DBR)) in the DM TMF.
• Performing and documenting periodic QC of DM TMF files and follow up on all action items until closure.
• Perform clinical database development, including data entry screen design, testing and validation based on the DBSD.
• Program, test and validate edit checks.
• Create the annotated CRF and other database-related documentation.
• Combine external data with the clinical database in cooperation with the Statistical Programmer.
• Perform initial coding of verbatim entries on adverse events, medical history and medications according to MedDRA and WHO-Drug dictionaries in the clinical database and forward to medical expert for quality control.
• Export data from the clinical database to authorized recipients (e.g. in CDISC SDTM format).
• Generation of queries based on edit checks or errors and omissions identified during data entry and manual data review to resolve identified problems.
• Provide material for Data Review Meeting (DRM) and participate in DRM if required.
• Perform database lock and unlock procedures.
• Provide validated data exports from the EDC system or the clinical database to authorized recipients (e.g. related to SAE Reconciliation and medical coding where applicable).
• Communication with the sponsor in close cooperation with the PM.
• Attend meetings with project team and/or client.

Duties and responsibilities of the Senior Data Manager include all those of a Data Manager and in addition:

• Provide the Project Management Report in case the PM group is not involved in the project.
• Develop, review and revise ERGOMED SOPs within their area of expertise (upon assignment from Head of DM) in order to ensure consistency with Good Clinical Practices and other applicable regulatory standards / requirements.
• Contribute to ERGOMED training programs to enhance knowledge of Good Clinical Practices, Good Clinical Data Management Practice, related guidance documents, ERGOMED SOPs and Working procedures.
• Deliver training and mentorship to DM and other operational staff as applicable.