Job Description

Associate Director, Clinical Systems Implementation manages activities related to the successful validation, implementation, and use of multiple small to medium size/complexity applications or large/highly complex application or a platform. 

The role effectively and efficiently engages stakeholders both internal and external, working with leaders throughout the business in Research & Development, Information Technology, Quality, and Regulatory in pursuit of clear and accurate enablement of digital and emerging technologies and innovation.

The role represents business users in application related discussions related to the design, development, and deployment of the application to support business process, and works in close collaboration with our Research & Development division-IT. 

The role ensures compliance to company policies, agency regulations and related guidance around technology and applies data stewardship and data governance principles in the management of the application.

Responsibilities: 

• Serve as a Subject Matter Expert (SME) on the use of the application and lead completion of various System Development Life Cycle (SDLC) activities.
• Lead collection, tracking and prioritization of requests from users requiring modifications (upgrades or bug fixes) to existing systems.
• Partner with various business functional stakeholders and our Research & Development division-IT to support creation of high-impact & high-value business cases for innovation opportunities and advance selected solutions from proof of concept to pilot and implementation at scale, ensuring required due diligence has been carried out, and the solution is audit/inspection ready, if applicable.
• Represent the business during discussions with the system vendor and Technical Lead as the primary contact and to ensure right business needs and enhancements are proposed & evaluated for feasibility.
• Collaborate with user experience experts and collect early and ongoing feedback from users to ensure solution being developed will provide optimum user experience once enabled.
• Partner with the Technical Lead & Business Analyst to document and approve requirements that have appropriate criticality assigned, are testable and will enable the desired functionality to support the business process.   
• As applicable, work with business users to identify study specific changes needed to the application and integration to connected systems; enable these changes with the help of our Research & Development division-IT, vendor, system owners of connected systems. 
• Identify and manage the Key Performance Indicators (KPIs) to measure outcomes and success of technology solutions being implemented to improve clinical operations productivity and site and patient experiences.
• Approve change requests for upgrades/bug fixes/data changes and coordinate release planning and assessment for the business in collaboration with IT.
• Work with solution provider to ensure appropriate enhancements are incorporated in vendor roadmap that not only supports current process/needs but also future vision and innovative technology options. 
• Establish a baseline for customer satisfaction, monitor customer satisfaction regularly through forums and surveys, and leverage the insights gained from customer feedback to refine the roadmap.
• Create appropriate training materials (training manuals/e-learnings/Job Aids) and process documentation (Standard Operating Procedures (SOP's)/Guidelines) to support the use of the system. Periodically assess and update if needed.
• Facilitate trainings to ensure users are appropriately trained in the use of the system.
• Communicate system functionality changes and impact to existing processes to the users in a concise and timely manner.
• Perform business process impact assessments for new applications or enhancements to existing application and provide details to Business Process/Sub-process Owners to make necessary updates to the processes.
• Contribute to the ongoing development of global standardized procedures for the use and maintenance of the application across functional groups and countries.
• Monitor support metrics and performance of the system on routine basis to assess needs for improvements (added resources or technology improvements). Work with business to ensure optimized use of product features.
• Partner with the IT Support Lead to coordinate downtime communications – content, timing, contacts, etc.
• Work with IT and support team to create user provisioning and deprovisioning process.
• Periodically audit user access to system to ensure only intended users have access.
• Manage User Acceptance Testing (UAT) related activities such as assessing UAT needs, developing high-level UAT plans, identifying testers for UAT, drafting test scripts, setting up data to support testing, conduct dry run of test scripts, make needed updates, perform testing, track issues during testing and ensure proper SDLC documentation is completed prior to deployment.
• Ensure proper process and guidelines are in place to share and exchange data between applications & apply record retention policy.
• Act as primary business contact for assigned systems during audits and inspections and collaborate with IT and process owners to respond to all audit and inspection related requests in a timely manner.

Experience & Skills:

• Bachelor's degree or higher with 5+ years of experience in Science, Clinical Research, Computer Science, or similar fields
• At least five years of experience in technology implementation, business process improvement, project management, systems analysis or systems maintenance/support
• Broad understanding of drug development -safety, clinical trials, trial design, data management, trial operations, regulatory, privacy, International Council for Harmonisation (ICH), and Good Clinical Practice (GCP) required.
• Ability to quickly gain thorough understanding and become subject matter expert in a new business area as needed, e.g. Risk Based Monitoring, Structured Content Authoring, clinical content standards.
• Strong verbal & written communication skills - able to present information confidentially and effectively to leadership, peers, and team.
• Ability to proficiently interact with all levels of management, exert influence to achieve results without authority and successfully manage senior/Executive level stakeholders.
• Project management experience is a plus.
• Deep knowledge and understanding of Clinical Trial processes as well as quality management and control tools. 
• Experience with critical clinical systems such as Clinical Trial Management Systems (CTMS), electronic Trial Master File (eTMF), Electronic Data Capture (EDC) system, clinical portal and basic reporting and MS Office tools.
• Understanding metrics and being able to identify trends.
• Fluency with the respective cross-functional interdependencies, roles and enabling tools/technologies. 
• Able to identify critical input and outputs that drive business processes and dependencies on process (workflow) vs. technology (dataflow).
• Exposure to a global environment, with multi-cultural and organizational operating models; appreciation for country requirements/needs vs. US standards.
• Requires management and leadership skills, analytical ability, good judgment, ability to multi-task, conflict resolution expertise and discretion.
• Customer service orientation and the ability to work effectively with clients, third party vendors, quality and IT management/staff.
• Experience in training user community.
• Experience in Risk Based Quality Management (RBQM) (Critical to Quality (CtQ), Key Risk Indicators (KRI), Quality Tolerance Limits (QTL), etc.)

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Required Skills:

Preferred Skills:

Current Employees apply

Current Contingent Workers apply

US and Puerto Rico Residents Only:

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

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

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 .

You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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. 

Employee Status:

Relocation:

VISA Sponsorship: