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.
- 1 -2 years relevant experience in a Clinical data management department in a biopharmaceutical setting or preferably a CRO. (As per qualification and organization need).
- ·ICH-E6-GCP certificate.
- Knowledge of GCP, ICH guidelines, GCDMP, and CDASH/CDISC data standards.
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.
