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MSD Associate Specialist m/f/d Clinical Data Management GDO CDMs Kenya, Nairobi County, Nairobi 482396622
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Job Description
r Team asto be based in our new office in Zürichis the1st of September 2024.
Under the direction of the applicable management, the Associate Specialist (m/f/d), Clinical Data Management GDO is responsible for executing end to end data management activities pertaining to clinical trials, including but not limited to; data management tool and system development, validation and maintenance, data collection, data integrity review and reconciliation, query management, medical coding, and database lock preparation, in compliance with our company Standard Operating Procedures (SOPs) and ICH-GCP guidelines.
THE PRIMARY ACTIVITIES INCLUDE BUT ARE NOT LIMITED TO:
Participates in the development and change request implementation of data management tools and systems for the clinical trial data management activities under the direction of the SCDM/LCDM
Runs data integrity check reports in accordance with data review plans and relevant SOPs
Raises questions to investigational site staff and internal and external vendors, reviews responses and corresponding data corrections to confirm identified issue resolution
Responsible for the execution of user acceptance testing of data management tools under the guidance of the SCDM/LCDM
Escalates overdue items, including but not limited to outstanding questions and missing visits
Assists the Senior/Lead CDM with data management activities to resolve all identified data issues prior to study database lock
Complete trial level archiving activities under the direction of the SCDM/LCDM including, but not limited to, filing of essential documentation
Maintains compliance with standard key performance indicators according to process expectations at the protocol level
Monitors data quality and cycle-time performance measures to maintain compliance, performs root cause analysis and implements action plans as needed
Proactively communicates with Senior/Lead CDM to share project status, risk assessment and outstanding item resolution status
Education and Experience:
B.A. or B.S. degree completed or currently enrolled, preferably in Medicine, Pharmacy, Nursing, Biological Sciences, or health care related discipline. Will also consider some coursework (without completion) with relevant professional experience
Knowledge and Skills:
Self-motivated, excellent in work planning, time management and multi-tasking
Fluent oral and written English skills
Good sense and awareness of regulations and policies
Able to work under pressure and in a changing environment with flexibility
Good communication skills with the ability to communicate with both the technical and business areas
Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards
Current Contingent Workers apply
*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
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