Specialist - Clinical Data Services job in Rahway
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|Employer:|| Merck & Co.|
|Category:||Clinical Data Management|
|State:||New Jersey (NJ)|
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.
Assumes the responsibilities for Clinical database development deliverables including database set-up and edit check programming to support multiple clinical programs. Coordinates and participates in the following activities:
• Responsible for the clinical database design activities for startup of a protocol which include design and implementation of clinical database for electronically captured data. Participates in the review of eCRFs and edit checks, database development, programming of edit checks. Review the technical feasibility of study team proposed edit checks and technically implements them. Work effectively among CDS team to communicate issues and ideas to improve the business.
• Interface with members of study teams, including external CROs/Vendors where applicable, to integrate study team requirements into all deliverables.
• Supports technical investigation and resolution of clinical database issues. Under proper change management, responsible for change requests and incidence correction for clinical databases. Provides technical and impact analysis support for change requests.
• Participate in extra activities including, but not limited to, study improvement task forces, automations, initiatives, testing of new systems, training and mentoring. Ongoing support in a dynamic and matrix organization.
Education Minimum Requirement:
B.A. or B.S. degree, preferably in computer science, information technology, life-sciences, or other healthcare related discipline.
Required Experience and Skills:
• Educational exposure to software design, procedure language, development theory and techniques, testing methodologies, and software documentation.
• A minimum of three (3) years of database development and programming experience, at least 2 years of which is in clinical database development.
• Proficient in developing and supporting Clinical Data Management System.
• Solid knowledge of MS Windows/Office software and exposure to web based applications.
• Ability to work independently, multi-task, and complete development activities in a highly dynamic, fast paced work environment.
• Effective communicator (in written and verbal form) with proven ability to maintain productive, customer focused working relationships with both technical and non-technical areas.
• Possesses desire to continuously learn and innovate; has participated on cross-functional process and technology improvement initiatives.
• Possesses knowledge and understanding of clinical development, FDA regulations (21 CFR Part 11), and GCP/ICH guidelines.
Preferred Experience and Skills:
• InForm Architect, Central Designer, Oracle Clinical, DMW, PL/SQL, C-Sharp
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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Visa sponsorship is not available for this position.
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