Senior Coordinator, Interactive Response Technology (IRT)

Job Description

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.

Primary Activities:

• 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

(Hybrid Work Arrangement)

Prerequisites:

• B.A. or B.S., preferably in life sciences, computer science, engineering or related discipline.

• 4 years’ of IRT and/or COA working experience preferred.

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.

#EligibleforERP

MRLGCTO

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NOTICEFORINTERNALAPPLICANTS

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 separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Under New York State, Colorado State, Washington State, and California State 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:

$107,600.00 - $169,400.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

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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.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

No

Requisition ID:R268884