CTMS Process Senior Specialist Job
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.
It is critical that Merck receives high quality data regarding clinical trial operations. Merck’s CTMS is the system of record for clinical trial operations for trials sponsored by Merck & Co., Inc. Appropriate use of the system is intended to ensure good quality and traceability of study conduct. This role is designed to ensure proper documentation and communication of system use in alignment with business processes.
CORE Accountabilities and Responsibilities:
- Work closely with the Process Leads to understand global clinical processes that the CTMS system supports and help to evaluate how process changes may impact system requirements and suggest possible CTMS enhancements that can improve process quality and efficiency.
- Work with IT, Business System Owner (BSO) of CTMS and other integrated systems, Process Leads and the general User Community to develop & maintain the CTMS Process documentation.
- Assist BSO with testing of new functionality or bug fixes for CTMS as per System Development Life Cycle Policy 13.5.
- Assist CTMS BSO with development and maintenance of documentation in support of the use of CTMS.
- Support CTMS related department, organizational and regulatory deliverables and ensure adherence to Merck policies and procedures.
- Partner with and train global CTMS SMEs and reference data administrators to ensure quality, consistency and completeness of CTMS data.
- Develop & maintain CTMS SYNC community and ensure communication is timely and appropriate.
- Draft and send communications and present CTMS topics via on-line or Face to Face meetings, as required.
- Support corporate and departmental audits and regulatory inspections by providing documentation or CTMS data as needed, assess and determine corrective actions related to CTMS Process documentation or training material to address findings.
- Training: Actively collaborate with MRL Learning and Development for the development and implementation of training to support CTMS processes.
- Bachelor's degree
- Five years of overall clinical trial operations experience and at least two years of experience in clinical trial management.
- Deep knowledge and understanding of Clinical Trial processes as well as quality management is required.
- Experience delivering effective process improvement solutions.
- Basic understanding of Clinical Trial Management System.
- Requires project management and leadership skills, analytical ability, good judgment, ability to multi-task.
- Customer service orientation and the ability to work effectively with clients, third party vendors, quality and IT management/staff.
- Requires experience in training user communities.
- Strong verbal & written communication skills.
- Excellent teamwork and leadership skills, including conflict resolution expertise and discretion.
- Ability to proficiently interact with all levels of management and exert influence to achieve results.
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 Research Generic
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck