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Job DescriptionNew hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.Oversees and coordinates Clinical Database activities for clinical programs including the review of eCRFs, edit check specifications, and database development. Ensures adherence to clinical database standards, SOPs and Process Guidelines. Plans appropriately to ensure adherence to timelines for all Clinical Database services deliverables and escalate risks to management. Interface with members of study teams to integrate study team requirements into all deliverables. Interface with CDS manager/supervisor to assure consistency of technical and process strategies. Aligns others around a positive direction. Develops challenging but achievable objectives that clearly support stated organizational goals. Interacts and communicates clinical database processes and requirements to external vendors.Leads and participates in extra activities including, but not limited to, improvement task forces, automations, testing of new systems and helps coordinate CDS technical initiatives. Contributes strategies, innovative and creative solutions to enhance processes and increase productivity of the group. Provides ongoing clinical database support to other departments. When necessary, may perform development activities such as database development or Peer Review.Provides oversight to Clinical Database Developers. Participates in mentoring and training of new hires and ongoing technical development of Clinical Database Developers. Provides input into the performance appraisals of Clinical Database Developers to management. Ensures the adherence to standards in the development, documentation and maintenance of data dictionaries.Performs as a Subject Matter Experts (SME) of clinical database and Electronic Data Capture activities including the creation of clinical databases and data transfer files. Increases functional effectiveness by supporting departmental efforts to simplify and standardize procedures to the greatest extent possible, sharing best practices and leading continuous improvement efforts.Position Qualifications :Education Minimum Requirement:B.A. or B.S. degree, preferably in computer science, information technology, life-sciences, or other healthcare related discipline.Required Experience and Skills:Educational exposure to software design, procedure language, development theory and techniques, testing methodologies, and software documentation.
At least 7 years of database development including InForm, DMW, C#, SQL, PL/SQL and programming fundamentals experience.
Solid knowledge of MS Windows/Office software and exposure to web based applications.
Ability to work independently, multi-task, and complete development activities in a highly dynamic, fast paced work environment.
Effective communicator (in written and verbal form) with proven ability to maintain productive, customer focused working relationships with both technical and non-technical areas.
Possesses desire to continuously learn and innovate; has participated on cross-functional process and technology improvement initiatives.
Working knowledge applying CDISC CDASH standards.
Possesses knowledge and understanding of clinical development, FDA regulations (21 CFR Part 11), and GCP/ICH guidelines.
2-3 years project management experience.
#EligibleforERP#MRLGCTOWe 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., Kenilworth, 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.Current Employees apply HERE (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)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. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.For more information about personal rights under Equal Employment Opportunity, visit:EEOC Poster (https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf)EEOC GINA SupplementOFCCP EEO Supplement (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf)Pay 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.Search Firm Representatives Please Read CarefullyMerck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:Flexible Work Arrangements:Flex Time, Remote WorkShift:Valid Driving License:Hazardous Material(s):NoNumber of Openings:1Requisition ID: R163361
