Assoc. Spclst, Clinical Data Mgmt (Hybrid)

MSD•Rahway, PA

1d•Hybrid

About The Position

Under the direction of the applicable management, the Clinical Data Manager (CDM) 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's Standard Operating Procedures (SOPs) and ICH-GCP guidelines.

Requirements

High School Diploma (or equivalent).
Self-motivated, excellent in work planning and time management.
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.
Adaptability
Analytical Problem Solving
Clinical Data Cleaning
Clinical Data Management
Communication
Data Analysis
Data Documentation
Data Entry
Data Processing
Data Quality
Data Reporting
Data Review
Data Validation
Data Visualization
Good Clinical Practice (GCP)
Root Cause Analysis (RCA)
Teamwork

Nice To Haves

P referred B.A. or B.S. degree, in Medicine, Pharmacy, Nursing, Biological Sciences, or health care related discipline.
Adobe Acrobat
Adobe Forms
Adobe Sign
Microsoft Applications
Microsoft Excel
Microsoft Office
Microsoft Windows
VLOOKUP Function

Responsibilities

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.