Merck Senior Specialists, IRT COA in West Point, Pennsylvania

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. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

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.

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 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.

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 4 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

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.

If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com .

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Job Clinical Data Management

Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Other Locations: NA-US-NJ-Rahway

Title: Senior Specialists, IRT COA

Primary Location: NA-US-PA-West Point

Requisition ID: CLI007409