Mujtaba Mohammed

A passionate, positive, proficient, and dedicated individual with a desire to achieve, excel and evolve in Clinical Database Management, Validation with experience in multiple EDC tools like Medidata Rave, Veeva Vault, In-Form 6.0, 6.1, with strong knowledge of clinical trial, research, and life science domain. Expertise as a Data management Analyst on Study specific database design and build activities adhering to the timelines established by the project team and indicated by the contract. Conduct DM activities required for all global clinical trial. Experience in Edit Checks Programming, Dynamics Requirements, Derivations, Subject Fields Configurations. Accountable for accurate and timely Resolving Queries, Data Collection, Data Documentation, Data Entry, and Data Reporting and Statistical analysis of Clinical Data. Experience in the development of data management artifacts such as CRF specifications, Data Validation specifications, Data transfer specifications according to the Protocol of the study. Experience in building clinical studies on CDMS (clinical data management systems). Good knowledge and worked on different Oncology studies. Good Knowledge and understanding on RECIST. Performed UAT and Validation on Veeva Vault. Proficient in managing the data for pre-clinical, phase I and II clinical trial with therapeutic areas on Oncology, Hematology, Cardiovascular and Central nervous system, Immunology. Works collaboratively with Clinical Programmers, Statistical Programmers, Biostatistics, Clinical Research, Regulatory and Project Management staff to meet project deliverables and timelines for moderately complex clinical data acquisition, quality checking and reporting. Reviews designs for compliance and feasibility within the database system and consistency with any current standards and sponsor specification and meets with study teams on a regular basis during initial study setup to ensure effective communication and accuracy in design. Involved in study set up activities by Uploading e-CRF Filling/Completion Guidelines, PDF Generator, clinical views, limited updating/access in Configuration Areas, Submitting support tickets, SAS on Demand, Reports. Experience building tables using SQL. Knowledge and understanding of CDISC standards (CDASH, SDTM, ADAM), GCP standards, FDA ICH guidelines, 21 CFR Part 11 and recommended best practices. Able to practically apply solid information on the government guidelines overseeing the assurance of human subjects for example FDA, GCP/ICH rules, OHRP and HIPAA guidelines. Sound understanding of medical coding using MEDRA and WHO Drug dictionaries. Excellent project management skills, interpersonal, organizational, written/verbal communication skills, teamwork skills, and problem-solving skills. Ability to establish and maintain effective working relationships with co-workers, managers. Extensively strategic, detail oriented, multi-tasking, creative and quality-oriented approach.

CDMS Tools Experience: RAVE classic, Medidata, VeeVa Vault Central Designer 2.0 & 2.1 SDTM work knowledge In Form 6.0 and 6.1 MS Office, MS Visual, Tableau OCRDC Activities SQL, my SQL e-CRF design, DMP, UAT, Data Analysis, Data Review, Data entry validation, UAT, Data reporting, SAE reconciliation, External vendor data reconciliation, Data base freeze and lock. Intelligent and qualified Validation Engineer with extensive experience assessing software systems for alignment with specifications and project goals. Talented at documenting and reporting for accurate recordkeeping. Enthusiastic professional with focus on effectively analyzing test results.

• Used Microsoft Excel to develop inventory tracking spreadsheets.
• Documented and resolved complex issues which led to desired results.

• Certificate of basic life support and airway management from international trauma care, Trauma care international foundation - may 2015
• CPR, Trauma care international foundation
• Certificate of registration under dentist act 1948, TS Dental state council.