Senior Interactive Response Technology Coordinator
Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.
Summary, Focus and Purpose
The IRT and COA Senior Coordinator is responsible for providing end-to-end IRT (Interactive Response Technology) and 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 and COA Systems Standards. IRT and COA. The successful candidate also monitors system change requests and acts as our Company’s IRT and COA systems subject matter expert while liaising with external vendors. Accountable for making decisions regarding IRT and COA process, issue resolution, and deviations from standards.
Applies IRT and COA systems expertise on day-to-day activities when issues are escalated, communicates with internal and external stakeholders and escalates risks and is responsible for creating and enforcing IRT and COA systems standards, managing vendor performance, and supporting training and education of stakeholders.
Implement IRT and COA systems development process from kickoff to system go live, ongoing system change control, system closeout and database lock activities
Defines/redesigns IRT and COA development processes across vendor base. Identifies areas for process improvement and leads improvement activities
Creates and enforces the use of IRT and COA systems standards | Responsibilities may include creation/revision of IRT and COA systems standards, collaboration with vendors and internal stakeholders to define requirements, and monitoring standards utilization rate
Completes peer-review of the IRT and 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, driving 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 and COA vendors and our Company's Clinical Trial Team
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
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, any other project or conduct any other IRT and COA related task deemed appropriate by management
Serves as project manager of all IRT and COA systems activities for protocols assigned. Uses interpersonal, negotiating, and project management skills
Project plan development, execution, and change control. Coordinates resolution and risk mitigation of all IRT and 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. degree required | Preferably in life sciences, computer science, engineering or related discipline
Demonstrate knowledge of IRT and COA systems development processes
Knowledge of the clinical development process
Effective written and verbal communication skills
Independently conduct and manage multiple tasks at one time and meet deadlines in a complex environment with internal and external
Four years IRT and/or COA working experience
Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.
Who we are …
We are known as Merck & Co., Inc., Rahway, 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.
For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.
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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Under New York City law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected salary range:$96,700.00 - $164,500.00
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Flexible Work Arrangements:Hybrid, Work Week
Shift:1st - Day
Valid Driving License:Yes
Number of Openings:1