Offer summary
Qualifications:
Master's degree in a science field, 5 years data management experience, Knowledge of clinical data coding systems.Key responsabilities:
- Lead SPM and UAT meetings
- Create Data Management Plan
- Train users on eDC system
Match score not available
Priority access
Match score not available
Clinical Data Manager
72% Flex
UNLIMITED HOLIDAYS - EXTRA HOLIDAYS - EXTRA PARENTAL LEAVE - LONG REMOTE PERIOD ALLOWED
51 - 200
Employees
Job description
Your missions
Responsibilities:
- Conduct Study Preparation Meeting (SPM).
- Create and Validate Data Management Report Specifications.
- Work with Database Engineer to create the EDC database specification.
- Upload preliminary testing data into database.
- Conduct User Acceptance Testing (UAT).
- Create CRF Completion Guidelines.
- Create and sign-off on the Data Management Plan (DMP).
- Drive the use of data standards (i.e., CDISC).
- Participate in Study Element Team Meetings.
- Train end users on eDC system.
- Grant User Access for eDC system.
- Adds and/or updates external users' ids in GAMA.
- Contributes to departmental process improvement initiatives.
Requirements:
- Master's degree in a science related field.
- At least three (5) years data management and/or related work experience in a medical device or pharmaceutical Company.
- Working knowledge within areas of Good Clinical Practices, Good Clinical Data Management Practices, Design and Conduct of Clinical Trials/Studies, and related regulatory requirements and terminology.
- Experience working within a Clinical EDC system (e.g., OpenClincia, Medrio, Medidata Rave).
- Exposure to clinical data coding classification systems, e.g., MedDRA, LOINC, WHO-Drug, Data Standardization (CDISC STDM &/or ADAM), Meta-Data Repository.
- Programming knowledge Python or R is desired.
- Strong interpersonal, organizational, and communication skills.
- Excellent attention to detail and problem-solving skills.
- Ability to work effectively work in a team setting.
Required profile
Experience
Level of experience: Senior (5-10 years)
Industry :
Pharmaceuticals
Spoken language(s):
English
Check out the description to know which languages are mandatory. Soft Skills
- Interpersonal Skills
- Attention to Detail
- Problem Solving
- Teamwork
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