Merck Lead CDS Developer , Global Clinical Data Integration (GCDI) in Rahway, New Jersey
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
Primary activities include, but are not limited to:
40% 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.
30% 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.
20% 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).
10% 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.
Education Minimum Requirement:
- Bachelor’s degree in computer science or equivalent educational exposure to software design, procedure language, development theory and techniques, testing methodologies, and software documentation.
Required Experience and Skills:
- A minimum of four (4) years of clinical database development and programming experience.
Preferred Experience and Skills:
Demonstrated strong technical proficiency in a Clinical Data Management System. Particularly Inform, Inform Architect, Central Designer, DMW, SQL-PL/SQL, C#
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.
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Job Clinical Data Management
Title: Lead CDS Developer , Global Clinical Data Integration (GCDI)
Primary Location: NA-US-NJ-Rahway
Requisition ID: CLI008189