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. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
IRT & COA Sr. Specialist is responsible for providing end-to-end IRT & COA systems project management support including, but not limited to, gathering study-specific user requirements, executing UAT tasks, managing project timelines, managing and enforcing IRT & COA systems Standards. IRT & COA Sr. Specialist also monitors system change requests and acts as Merck's IRT & COA systems subject matter expert while liaising with external vendors. Accountable for making decisions regarding IRT & COA process, issue resolution, and deviations from standards.
Applies IRT & COA systems expertise on day-to-day activities when issues are escalated. Communicates with internal and external stakeholders and escalates risks. May participate and lead in process improvement initiatives, standards development and maintenance. Responsible for creating and enforcing IRT & COA systems standards, managing vendor performance, and supporting training &education of stakeholders.
- Execute IRT & COA systems development process from Kickoff to system go live, ongoing system change control, system closeout and database lock activities.
- Defines/redesigns IRT & COA development processes across vendor base. Identifies areas for process improvement and leads improvement activities
- Creates and enforces the use of IRT & COA systems standards. Responsibilities may include creation / revision of IRT & COA systems standards, collaboration with vendors and internal stakeholders to define requirements, and monitoring standards utilization rate.
- Performs peer-review of the IRT & COA systems specific documentations for quality (e.g. comparing paper COA measures with Developer version etc).
- Manages vendor performance and relationship(s). Responsibilities may include defining and implementing process with vendor representatives, monitoring and analyzing vendor and Merck performance metrics, performing root cause analysis and identifying corrective actions, and serving as point of escalation for vendor issues.
- Serves as project manager of all IRT & COA systems activities for protocols assigned. Uses interpersonal, negotiating, and project management skills to perform the following tasks:
- Project plan development, execution, and change control. Coordinates resolution & risk mitigation of all IRT & COA systems related issues and end of study vendor deliverables
- Activity definition and sequencing, duration estimation, schedule development, and schedule control.
- Risk management planning (i.e., risk identification, analysis, and response planning, as well as risk monitoring and control).
- Communication planning, information distribution, performance reporting, and project closure.
- Obtains internal and external stakeholder feedback; this may include meeting with vendor project managers and/or meeting with subject matter experts or representatives from stakeholder functional areas.
- Provides support for successful integration of Merck and vendor systems.
- Provides support for problem resolution between IRT & COA vendors and Merck Clinical Trial Team.
- May participate in training and education for stakeholders. May develop, or assist in development of, reference and/or training material. May provide cross-functional internal and external communication as needed.
- May provide support for the development / maintenance of relevant documentation, including applicable SOPs, job aids, and guidance documentation.
- May mentor new staff.
- May lead a continuous improvement special project or any other project or perform any other IRT & COA related task deemed appropriate by management. 5
Education Minimum Requirement:
- B.A. or B.S. degree, preferably in life sciences, computer science, engineering or related discipline.
Required Experience and Skills:
- 6 years' experience in Clinical Data Management with at least 3 years' of IRT and/or COA working experience.
Preferred Experience and Skills:
- Demonstrate knowledge of IRT & COA systems development processes.
- Knowledge of the clinical development process, preferably through submission; thorough knowledge of clinical data management.
- Effective written and verbal communication skills.
- Ability independently perform and manage multiple tasks at one time and meet deadlines in a complex environment working both internal to Merck and external to Merck.
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