Senior Coordinator, Interactive Response Technology - Hybrid

Merck

West Point (PA)

Hybrid

USD 117,000 - 184,000

Full time

7 days ago

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Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k) plan

Paid holidays and vacation

Bonuses and long-term incentives

Job summary

Merck is seeking an IRT Senior Coordinator to lead end-to-end IRT systems projects, from requirements gathering to go-live and post-implementation support. You will manage change control, vendor interactions, and process improvements to ensure standards are followed and risks are mitigated.

The role requires 4 years of IRT experience, strong knowledge of IRT development processes, and excellent communication skills to liaise with internal teams and external vendors.

Qualifications

4 years’ of IRT working experience preferred.
Demonstrate knowledge of IRT 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.

Responsibilities

Execute IRT systems development process from kickoff to system go live, ongoing system change control, system closeout and database lock activities.
Defines/redesigns IRT development processes across vendor base. Identifies areas for process improvement and leads improvement activities.
Creates and enforces the use of IRT systems standards. Responsibilities may include creation / revision of IRT systems standards, collaboration with vendors and internal stakeholders to define requirements, and monitoring standards utilization rate.
Performs peer-review of the IRT systems specific documentations for quality
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 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 related task deemed appropriate by management
Serves as project manager of all IRT 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 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

Skills

Clinical Development

Clinical Information Systems

Communication

Data Management

Good Clinical Practice

Interactive Response Technology

Project Management

Stakeholder Management

Standards Compliance

Teamwork

Education

B.A. or B.S. degree

Job description

Job Description

IRT Senior Coordinator is responsible for providing end-to-end IRT (Interactive Response Technology) systems project management support including, but not limited to, gathering study-specific user requirements, executing UAT tasks, managing project timelines, managing and enforcing IRT systems Standards. IRT Sr. Coordinator also monitors system change requests and acts as our Company’s IRT systems subject matter expert while liaising with external vendors. Accountable for making decisions regarding IRT process, issue resolution, and deviations from standards.

Applies IRT 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 systems standards, managing vendor performance, and supporting training &education of stakeholders.

Primary Activities

Execute IRT systems development process from kickoff to system go live, ongoing system change control, system closeout and database lock activities.
Defines/redesigns IRT development processes across vendor base. Identifies areas for process improvement and leads improvement activities.
Creates and enforces the use of IRT systems standards. Responsibilities may include creation / revision of IRT systems standards, collaboration with vendors and internal stakeholders to define requirements, and monitoring standards utilization rate.
Performs peer-review of the IRT systems specific documentations for quality
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 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 related task deemed appropriate by management
Serves as project manager of all IRT 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 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

Education

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

Experience

4 years’ of IRT working experience preferred

Knowledge And Skills

Demonstrate knowledge of IRT 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.

Required Skills

Clinical Development, Clinical Information Systems, Communication, Data Management, Good Clinical Practice (GCP), Interactive Response Technology, Project Management, Stakeholder Management, Standards Compliance, Teamwork

Preferred Skills

Deliverables Management, Identifying Risks, Project Management Operations

US And Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

Requirements

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

Benefits

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Salary

The salary range for this role is $117,000.00 - $184,200.00

Recruiter Policy

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

Travel Requirements

10%

Flexible Work Arrangements

Hybrid

Shift

1st - Day

Valid Driving License