Associate Director, Clinical Systems Implementation

Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.Brief Description of PositionAssociate Director, Clinical Systems Implementation will manage activities related to the successful implementation and use of multiple applications. The candidate will represent Global Clinical Trial Operations (GCTO) (business) in application related decisions that may or may not have a global impact, including but not limited to: the design, development and deployment of the process using the application, and work in close collaboration with the IT departments within our Research & Development Division. The Candidate will ensure compliance to Company, local laws and agency regulations and related guidance around technology. The Candidate will apply data stewardship and data governance principles in the management of the application.Responsibilities but not limited to:* Collect, assign, track, and prioritize requests from users requiring modifications (upgrades or bug fixes) to existing systems;* Develop business case in collaboration with process owners/stakeholders and our Research & Development Division IT for new solutions.* Approve change requests for upgrades/bug fixes/data changes and coordinate release planning and assessment for the business in collaboration with IT.* Ensure business needs and criticality of functionality are correctly documented in System Development Life Cycle (SDLC) documentation.* Review and approve appropriate validation documentation.* Represent business users and a voice of reason for Business users during discussions with the system vendors & IT Product Manager to ensure right enhancements are proposed & identified Partner with the IT Product Manager & Business Analyst to enable new system enhancements.* 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.* Provide subject matter expertise to business users of the application and system owners of the integrated applications, assessing their need for data Ensure business has appropriate training materials (training manuals/e-learnings/Job Aids) and process documentation (SOP''s/Guidelines) to support the use of the system.* Periodically assess and update if needed Communicate system functionality changes and impact to existing processes to the users in a concise and timely manner.* Communicate and coordinate the implementation of system changes to Business Process/Sub-process Owners, requestors, and stakeholders* 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.* Facilitate trainings to ensure users are appropriately trained in the use of the system* Collaborate with IT to ensure internal Service Level Agreement (SLA) is created for the application, reviewed and updated once a year.* 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 UAT related activities such as assessing UAT needs, developing and communicating high-level UAT plans* Coordinate UAT by identifying testers for UAT, ensuring proper training is completed, develop test cases, track issues during testing and ensure proper 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.* Responsible for completion of risk and privacy assessments and ensure adherence to risk and privacy policies.* 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.* Supporting Specimen Lifecycle Management department.Position Qualifications:Education Minimum Requirement:* BS degree > +12 years experience; or* MS/MBA/JD degree >+10 years experience; or* PhD +5 years experience.Required Experience and Skills:* Five to ten years of experience in clinical research/clinical development* At least five years of experience in technology implementation, business process improvement, project management, systems analysis or systems maintenance/support* Basic understanding of System testing & providing training to user communities* Deep knowledge and understanding of Clinical Trial processes as well as quality management and control tools is required.* Basic knowledge of Site Monitoring, Study Start up, Data Management, Pharmacovigilance, Essential Document Management, and Investigator/ Study Coordinator roles/ responsibilities.* Critically evaluate process implications of system changes and deal with conflict and bring to resolution.* Able to identify critical input and outputs that drive business processes and dependencies on process (workflow) vs. technology (dataflow).* Experience with critical clinical systems such as CTMS, eTMF, Electronic Data Capture (EDC) system, clinical portal and basic reporting and MS Office tools.* Excellent teamwork and leadership skills, including conflict resolution expertise and discretion.* Customer service orientation and the ability to work effectively with clients, third party vendors, quality and IT management/staffs* Skilled in MS Access, MS Excel, SQL or other database/query tools a plus.* Recognized as ''team player''* Possess good project management skills* Committed to continuous improvement* Analytical ability, good judgment, ability to multi-task* Strong verbal & written communication skills* Ability to proficiently interact with all levels of management and exert influence to achieve results.* Specimen lifecycle management experience preferred.EligibleforERPMRLGCTOONEGDMSWe are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we ''follow the science'' that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.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 APPLICANTSIn 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.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.Residents of ColoradoClick here to request this role''s pay range.New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.Current Employees apply HERECurrent Contingent Workers apply HEREUS 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. Please click here if you need an accommodation during the application or hiring process.For more information about personal rights under Equal Employment Opportunity, visit:EEOC PosterEEOC GINA SupplementOFCCP EEO SupplementPay Transparency NondiscriminationWe 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.Residents of Colorado:Click here to request this role''s pay range.Search Firm Representatives Please Read CarefullyMerck & 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:RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:10%Flexible Work Arrangements:HybridShift:Valid Driving License:Hazardous Material(s):Number of Openings:1Requisition ID:R198123

Created: 2025-09-06