2 Clinical Informatics jobs in Egypt
Clinical Data Management Associate
EGP90000 - EGP120000 Y
DataClin Group
Posted today
Job Viewed
Job Description
Location
: Hybrid – 3 days per week at Dataclin office, Dokki (Giza, Egypt).
Employment Type
: Full-time
Key Responsibilities
- Create project files for new studies and maintain project files for ongoing studies according to DATACLin's SOPs and/or contractual obligation to sponsor.
- Ensure accurate maintenance of files and documents in their specified location according to DATACLin's SOPs
- Track, scan, code, and retrieve documents as required for project team members.
- Provide Technical support in assigned projects, for example, downloading, copying, and keeping records of all electronic data.
- First and second tracking of received paper CRFs and DCFs.
- Ensure up-to-date study documents in the tracking system.
- Perform first and second entry of clinical trials data into the appropriate database, as per study-specific convention.
- Resolution of received query responses and update the database accordingly.
- Updating self-evidence correction lists generated in the relevant database.
- Perform archive procedures and prepare copies of project files as required by the Sponsor.
- Maintain a working knowledge and ensure compliance with applicable ICH-GCP, local regulatory requirements, and DATACLin SOPs and study-specific procedures.
- Complete routine administrative tasks promptly (e.g., Metrics and Reports)
- Respect for the Company's values and code of ethics.
Mandatory Requirements
- Bachelor's degree and/or other medical qualification.
- 0 - 1-year relevant experience in a clinical data management department in a biopharmaceutical setting or preferably a CRO (as per qualification and organization need).
- Knowledge of GCP and ICH guidelines.
Knowledge / Skills
- Experience with medical terminology
- Competent in written and oral English.
- Good computer skills are included, but not limited to, the knowledge of Clinical data management systems, knowledge of MS-Office products such as Excel, and Word.
- High interpersonal skills
- Show commitment to and consistently perform high-quality work.
- Meticulous, time management, teamwork, stress management, and punctuality.
This advertiser has chosen not to accept applicants from your region.
0
Senior Clinical Data Manager
EGP120000 - EGP180000 Y
DataClin Group
Posted today
Job Viewed
Job Description
Location
: Hybrid – 3 days per week at Dataclin office, Dokki (Giza, Egypt).
Employment Type
: Full-time
Key Responsibilities
Perform all data management activities as assigned, including but not limited to:
- Input data management relevant sections in study outlines and study protocol.
- Participate in CRF design and CRF completion guidelines
- Fully responsible for the completion of project files of assigned projects.
- Ensure accurate maintenance of files and documents in their specified location according to DATACLin's SOPs.
- Manage and track CRF flow and scanning, and input required data.
- Perform tracking, compare, and update.
- Ensure up-to-date study documents in the tracking system.
- Ensure that up-to-date received query responses are documented in the relevant tracking system and update the database accordingly.
- Build, test, and validate study database (paper-based or EDC)
- Development and validation of Edit checks and Edit checks development plan.
- Ensure and facilitate efficient study start-up.
- CRF annotation
- DB specification
- Data entry guidelines.
- Prepare study plans (Data validation plan, validation listing, Self-evidence correction plan, and Data management Plan).
- Guarantee that user acceptance testing and data transfer requirements are well defined.
- Generate Self-evidence correction lists and update the database accordingly
- Discrepancy management steps, including query generation, listing, and action. (Paper-based or EDC)
- Perform archive procedures and prepare copies of project files as required by the Sponsor.
- Prepare NSAE and SAE listing for reconciliation.
- Database coding using coding dictionaries (e.g. MedDRA)
- Responsible for final Database QC as an independent Data Manager.
- Perform Database lock and freezing activities.
- Represent Data management in audit, inspections, and meetings as required.
- Assist in developing and executing SOPs, departmental guidelines, and data standards to guarantee database quality control and data management compliance.
- Provide guidance and advice in addition to on-the-job training to the Data Administrator.
- Develop summary reports and graphs.
- Prepare and submit daily activities for the Data Administrator to facilitate and enhance company KPIs.
- Maintain a working knowledge and ensure compliance with applicable ICH-GCP, local regulatory requirements, and DATACLin SOPs and study-specific procedures.
- Complete routine administrative tasks promptly (e.g,. Metrics and Reports).
- Respect for the Company's values and code of ethics.
Mandatory Requirements
- Bachelor's degree and/or other medical qualification.
- 3 – 5 years relevant experience in a Clinical data management department in a biopharmaceutical setting or preferably a CRO. (As per qualification and organization need).
- Knowledge of GCP, ICH guidelines, GCDMP, and CDASH/CDISC data standards.
- Data management in clinical research.
- All Data Manager activities.
Knowledge / Skills
- Experience with medical terminology
- Competent in written and oral English.
- Good computer skills include, but are not limited to, the knowledge of Clinical data management systems, knowledge of MS-Office products such as Excel and Word.
- High interpersonal skills
- Seeks opportunities to develop experience and knowledge.
- Ability to organize and plan tasks.
- Sense of urgency in completing assigned tasks.
- Must be able to work independently but seek guidance when necessary, escalating issues as required.
- Shows commitment to and performs consistently high-quality work.
- Meticulous attention to detail.
- Effective time management I order to meet daily metrics or team objectives
- Ability to work in a team environment
- Stress management and punctuality.
This advertiser has chosen not to accept applicants from your region.
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