• Job Description

  Req#: R264123

  Job Description

  RaM Mapping Programmer I

  The Mapping Programmer (MP) is responsible for ensuring the timely and quality delivery of SDTM and Contivo mappings to ensure data migrate from the InForm™ Reporting database to the Clinical Data Repository (CDR) as specified. Collaborates with the Clinical Database Services (CDS) Developers, Global Clinical Data and Standards (GCDS), Technical Services (TS) and BARDS colleagues on technical requirements. Programs the SDTM mappings. Collaborates with the Clinical Database Testing (CDT) Analyst to ensure quality delivery. The MP acts as a point of escalation for any issues or delays to timeline associated with SDTM Mapping, CDR Metadata Setup, CDR UAT, Contivo, and data flow to CDR.

  Assumes the responsibilities for Clinical database development deliverables including database set-up and edit check programming to support multiple clinical programs. Coordinates and participates in the following activities:

  Creates and develops clinical databases and data transfer files according to written specifications. Ensures adherence to clinical database standards, SOPs and Process Guidelines. Leads and participates in the review of eCRFs and edit checks, database development, programming of edit checks, and scripts to aid in transfer of electronic data files.

  Oversees and coordinates clinical database activities for multiple clinical programs. Interface with RaM Mapping manager/supervisor to assure consistency of technical and process strategies. Acts as a technical resource to other members of the group. Plans appropriately to ensure adherence to timelines. Interface with members of study teams, including external CROs/Vendors where applicable, to integrate study team requirements into all deliverables.

  Trains new hires and participates in the interview process. Provide ongoing training and development to Clinical Database Developers on existing standards. Helps to develop a customer oriented and can-do attitude in the group and contributes as subject matter expert for trouble-shooting findings.

  Leads and participates in extra activities including, but not limited to, task forces, testing of new systems and helps coordinate RaM/CDS Mapping 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. Provides technical and impact analysis support for change requests.

  Position Qualifications :

  Education Minimum Requirement:

  • B.A. or B.S. degree, preferably in computer science, information technology, life-sciences, Data Science or other healthcare related discipline. Master’s degree is preferred.

  Experience and Skills**:

  • Bachelor’s degree in computer science or equivalent educational exposure to software design, procedure language, development theory and techniques, testing methodologies, and software documentation required.

  • 1 years of database development and programming experience preferred.

  • Knowledge of clinical database development.

  • Knowledge in developing and supporting Clinical Data Management System.

  • Experience with InForm, InForm Architect, Central Designer, and SQL-PL/SQL, SAS, R Programming, XML, Java, Python, data analytics and Contivo preferred.

  • Knowledge in CDISC Standards (SDTM, CDASH, Define.XML). SDTM controlled terminology especially in Oncology, Vaccines and other priority therapeutic areas. Good knowledge in data dictionaries, libraries and MDR etc.

  • 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.

  • Possesses knowledge and understanding of clinical development, FDA regulations (21 CFR Part 11), and GCP/ICH guidelines.

  #EligibleforERP

  MRLGCTO

  #ONEGDMS

  NOTICE FOR INTERNAL APPLICANTS

  In 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.

  Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

  Current Employees apply HERE

  Current Contingent Workers apply HERE

  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 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:

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  Pay Transparency Nondiscrimination

  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.

  Learn more about your rights, including under California, Colorado and other US State Acts

  U.S. Hybrid Work Model

  Effective 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, generally Tuesday, Wednesday and either Monday or 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”.

  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:

  Regular

  Relocation:

  No relocation

  VISA Sponsorship:

  No

  Travel Requirements:

  10%

  Flexible Work Arrangements:

  Hybrid

  Shift:

  1st - Day

  Valid Driving License:

  Yes

  Hazardous Material(s):

  No

• About the company

  Merck & Co., Inc.,

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