MSD
Job title:
Associate Director, Clinical Systems Implementation
Company
MSD
Job description
Job DescriptionJoin our team at our company, a premier research-intensive biopharmaceutical company. We are seeking an Associate Director, Clinical Systems Implementation to manage activities related to the successful implementation and use of multiple applications. This role is an opportunity to work at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.ResponsibilitiesManage activities related to the successful implementation and use of multiple applications.Represent Global Clinical Trial Operations (GCTO) (business) in application related decisions that may or may not have a global impact.Ensure compliance to Company, local laws and agency regulations and related guidance around technology.Apply data stewardship and data governance principles in the management of the application.Collect, assign, track, and prioritize requests from users requiring modifications to existing systems.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 SDLC documentation.Review and approve appropriate validation documentation.Partner with the IT Product Manager & Business Analyst to enable new system enhancements.Provide subject matter expertise to business users of the application and system owners of the integrated applications.Ensure business has appropriate training materials and process documentation to support the use of the system.Communicate system functionality changes and impact to existing processes to the users in a concise and timely manner.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.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.Manage UAT related activities such as assessing UAT needs, developing and communicating high-level UAT plans.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.QualificationsEducation Requirement:BS degree with 12 years of professional experience.OrMS/MBA/JD degree with 10 years of professional experience.OrPhD with 5 years of professional experience.Experience Required: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.Experience with critical clinical systems such as CTMS, eTMF, Electronic Data Capture (EDC) system, clinical portal and basic reporting and MS Office tools.PreferredFive years of experience in clinical research/clinical development.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.#EligibleforERP
ResearchandDevelopmentGCTONOTICE FOR INTERNAL APPLICANTSIn accordance with 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.Current Employees applyCurrent Contingent Workers applyUS 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 if you need an accommodation during the application or hiring process.We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: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.U.S. Hybrid Work ModelEffective 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, Monday – 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”.The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. 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 US salary range: $135,500.00 – $213,400.00Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed .San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance OrdinanceLos 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 OrdinanceSearch 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: RegularRelocation: No relocationVISA Sponsorship: NoTravel Requirements: 10%Flexible Work Arrangements: Not ApplicableShift: 1st – DayValid Driving License: NoHazardous Material(s): NoJob Posting End Date: 11/6/2024*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Expected salary
Location
Gwynedd, PA – Wales
Job date
Thu, 24 Oct 2024 04:45:15 GMT
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