Job Description

Under the direction of the applicable management, the Senior Clinical Data Manager (SCDM) 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 integrity review and reconciliation, query management, and database lock preparation/execution, in compliance with Company's Standard Operating Procedures (SOPs) and ICH-GCP guidelines. 

Responsibilities:

• Execute end-to-end data management activities pertaining to clinical trials.

• Develop, validate, and maintain data management tools and systems.

• Ensure data collection, data integrity review, and reconciliation.

• Manage queries, medical coding, and database lock preparation.

• Assume data management responsibilities for larger, more complex, or higher priority protocols.

• Ensure that ¨Risk-based Data Validation QC¨ is executed in compliance within the protocol requirements.

• Coordinate general ad-hoc Sponsor Data Entry (SDE) process for the protocol.

• Provide protocol-specific training of SDE Process to Clinical Data Managers (CDM).

• Triage, research, discuss, and resolve report outputs provided by Clinical Development Scientists (CDS) and Statisticians.

• Prepare, create, validate, and review data management tool specifications and tools.

• Coordinate User Acceptance Testing (UAT) of the Clinical Database Repository.

• Communicate, track global status, and resolve issues at the study level with Lead Clinical Data Manager (LCDM).

• Support LCDM in interaction and communication with internal and external customers and stakeholders.

• Communicate with Clinical Trial Operations team regarding site level issues on a protocol.

• Monitor protocol level cycle time performance (metrics) and follow up on specific countries/sites metrics issues.

• Assess, report, and communicate study level status with LCDM.

• Coordinate and mentor CDMs and other Senior Clinical Data Managers (SCDMs) to maintain compliance with SOPs, data management plans, and data review plans.

• Be assigned to special responsibilities related to process maintenance, data quality assessment, staff training, and mentoring.

• Contribute to special activities such as supporting Data Management Center (DMC) Process Owner (PO) Models.

• Participate in cross-functional technical or process improvement projects.

Education and Experience:

At least B.A. or B.S. degree, preferably in life science, or health care related discipline with at least 2-year professional experience in clinical data management;

• Two years’ professional experience in clinical data management (CDM)

• Self-motivated, excellent in work planning and time management.

• Able to work under pressure and in a changing environment with flexibility.

• Proven leadership skills, specifically the ability to coordinate the work of others and influence team and management on decision making.

• Demonstrates a deep understanding of GDMS-CDM core processes and how they relate to key daily activities

Required Skills:

Adaptability, Adaptability, Clinical Data Cleaning, Clinical Data Management, Clinical Trials, Customer-Focused, Data Analysis, Database Development, Data Processing, Data Quality, Data Quality Assessments, Data Quality Assurance, Data Review, Data Validation, Data Visualization, Decision Making, Electronic Data Capture (EDC), Good Clinical Practice (GCP), Learning Agility, Management System Development, Medical Codes, Medical Insurance Coding, Pharmacovigilance, PL/SQL (Programming Language), Pressure Management {+ 1 more}

Preferred Skills:

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Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

no

Job Posting End Date:

08/5/2026

*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.