andré sygulla

medizinischer dokumentar

About

Experienced Clinical Data Analyst with more than 24 years in Data Management. Broad background in clinical trials management of phase I/II/III trials in various indications including coordination of Data Management activities, clinical data review, edit check review and data clarifications on complex projects. Significant expertise in Clinical Coding.

Country

germany

City

berlin

Industry

pharmaceuticals

Skill

Experience

medizinischer dokumentar

professional reorientation

2017-4 - Present · 9 yrs 6 mos

clinical data manager

parexel

1993-10 - 2009-6 · 15 yrs 9 mos

data entry coordinator

parexel

1992-3 - 1993-9 · 1 yr 7 mos

senior clinical data analyst

parexel

2009-7 - 2017-3 · 7 yrs 9 mos

* Coordination of Data Management activities on international multi-center trials * Preparation of data review guidelines and data flow procedures * Assistance in developing and review of Case Report Forms * Review of data entries * Clarification of legibility of medical text entries * Documentation, clarification and integration of data queries * Translation of medical data * Reconciliation of AEs and SAEs in cooperation with the Medical Safety department * Medical plausibility control of clinical data * Preparation and consistency control of study specific patient profiles * Completion of relevant audit trail materials * Tracking and reporting data management status * Coding of medical data according to international coding systems (e.g. MedDRA, WHO-DD) * Coding consistency and quality control * Providing internal training on MedDRA and WHO-DD coding, coding tool application and standard coding processes * Site Coding Consultant, Data Management Berlin