Senior Specialist, Clinical Data Management

MSD

Senior Specialist in Clinical Data Management overseeing clinical database activities and ensuring adherence to standards. Collaborating with study teams and providing ongoing training and support.

Posted 7/22/2026full-timeRahway • New Jersey • 🇺🇸 United StatesSenior💰 $117,000 - $184,200 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Clinical Database Development and Management, with strong technical proficiency in Veeva EDC, SQL, and Oracle databases. Capable of leading teams, ensuring adherence to clinical standards, and fostering effective communication across functional areas.

Highest-signal resume keywords

Clinical Database DevelopmentVeeva EDCSQL-PL/SQLProject ManagementClinical Data Management System

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Database DevelopmentData Cleaning ProgrammingOracle DatabasesClinical Database StandardsECRF ReviewEdit Check ProgrammingData Transfer FilesClinical Database SupportRegulatory Affairs KnowledgeGxP Guidelines

Soft Skills

LeadershipCommunication SkillsInterpersonal SkillsOrganizational SkillsCustomer Focus

Tools & Technologies

MS WindowsMS OfficeWeb-Based ApplicationsClinical Data Management System

Industry Keywords

Clinical DevelopmentFDA RegulationsICH GuidelinesDrug Discovery Process21 CFR Part 11

Tech Stack

Tools & technologies

OracleSQL

About the role

Key responsibilities & impact

Oversees and coordinates clinical database activities for multiple clinical programs.
Interface with CDS manager/supervisor to assure consistency of technical and process strategies.
Acts as a technical resource to other members of the group.
Plans appropriately to ensure adherence to timelines.
Interface with members of study teams, including external CROs/Vendors where applicable, to integrate study team requirements into all deliverables.
Creates and develops clinical databases and data transfer files according to written specifications.
Ensures adherence to clinical database standards, SOPs and Process Guidelines.
Leads and participates in the review of eCRFs and edit checks, database development, programming of edit checks, and scripts to aid in transfer of electronic data files into the Clinical Data Management System (CDMS).
Trains new hires and participates in the interview process.
Provide ongoing training and development to Clinical Database Developers on existing standards.
Helps to develop a customer oriented and can-do attitude in the group and contributes as subject matter expert for trouble-shooting findings.
Leads and participates in extra activities including, but not limited to, task forces, testing of new systems and helps coordinate CDS technical initiatives.
Contributes strategies, innovative and creative solutions to enhance processes and increase productivity of the group.
Provides ongoing clinical database support to other departments.
Assist clinical database manager/supervisor in project planning, manpower projections and resource allocations across therapy areas.

Requirements

What you’ll need

4 years of database development or data cleaning programming experience, at least 3 of which including clinical databases and programming.
Demonstrated strong technical proficiency in a Clinical Data Management System. Particularly Veeva EDC, Central Designer, SQL-PL/SQL.
At least 4 years’ experience with Oracle databases and SQL.
Solid knowledge of MS Windows/Office software and exposure to web-based applications.
Ability to establish and maintain good working relationships with different functional areas.
Strong sense of urgency and customer focus.
Project Management skills
Ability to present in a group environment
Leadership, verbal and written communication, interpersonal and organizational skills
Desire and ability to learn new processes and technologies
Broad knowledge of Clinical Development and Regulatory Affairs requirements
Ability to multi-task, work independently, and good communication skills
Understanding of drug discovery process, FDA regulations, GxP guidelines, ICH guidelines, clinical database cleaning process, and 21 CFR Part 11.

Benefits

Comp & perks

medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays
vacation
compassionate and sick days