Associate Specialist, Clinical Data Management

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.  

• 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.  

• High School Diploma (or equivalent).
• Preferred: B.A. or B.S. degree, in Medicine, Pharmacy, Nursing, Biological Sciences, or health care related discipline. 

• 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.

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Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.