Senior Coordinator, Interactive Response Technology (IRT) ( MERCUSR150370ENUS)
New hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.
Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
IRT & COA Senior Coordinator is accountable for providing end-to-end IRT (Interactive Response Technology) & COA (Clinical Outcome Assessment) 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. Coordinator also monitors system change requests and acts as our Company’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. Speaks with internal and external stakeholders and escalates risks. May participate and lead in process improvement initiatives, standards development and maintenance. Accountable 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 our Company's performance metrics, performing root cause analysis and identifying corrective actions, and serving as point of escalation for vendor issues.
- 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 our Company's and vendor systems
- Provides support for problem resolution between IRT & COA vendors and our Company's 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
- 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
- B.A. or B.S., preferably in life sciences, computer science, engineering or related discipline.
- 6 years’ in Clinical Data Management with at least 4 years’ of IRT and/or COA working experience
- Knowledge 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 and external to our Company.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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