Data Management Specialist

Role Summary

To make up our team, we are looking for professionals who want to contribute to our mission of improving the lives of more and more people.

If you have an innovative profile, think outside the box, and enjoy working in a modern and dynamic environment, this position is for you.

Come with us and be part of this journey. #VemSer Synvia

We count on you to

Assist with data management activities in clinical research (Data Management);

Control, creation and maintenance of Excel spreadsheets, Word documents and Power point presentations;

Preparation of the Query Plan.

Database cleaning (Data Cleaning).

Queries Management (creation, control, analysis of responses).

eCRF/IWRS programming in specific software.

Support for study users (Questions, user creation, access control to the EDC).

Creation of Data Management documentation (Ex. DMP, UAT, DBL, User Manual, PSI Dispensing Manual)

Meet the deadlines established for the studies under your responsibility.

Carry out all necessary training.

Be the contact person (internal and external) for the studies that are under your responsibility in relation to data management.

Conducting training on the use of eCRF when requested.

Unit of work

Home Office

Work Scale

5x2 - 8am to 5pm

Requirements

What we look for

Completed higher education in Computer Science, Information Systems, Statistics, Administration, health areas (Biomedicine, Pharmacy, Nursing, Biology, Biological Sciences and related areas) or related areas;

• Experience in data management in clinical research (Data Management), preferably in CROs, research centers or pharmaceutical industry;
• Experience in designing and configuring eCRF (CRF Design) in EDC systems;
• Experience with preparing Query Plans, Data Cleaning and Database Lock;
• Knowledge in implementation and management of IWRS/IRT;
• Mastery of good practices and regulatory requirements applicable to clinical research (ICH-GCP, ANVISA).
• Intermediate/advanced English for reading protocols and regulatory documentation.

Benefits

What benefits we offer you

• Transport Voucher;
• Parking (depending on availability);
• Health Plan at no monthly cost to the employee, with co-participation in exams and consultations;
• Dental Plan with monthly payment co-participation;
• Life Insurance at no cost to the employee;
• Flexible food/meal voucher;
• Pharmacy Agreement;
• SESC Partnership;
• Physical health program - TotalPass;
• Day Off – Health professional;

Childcare allowance (according to internal policy).