Lead RaM Mapping Programmer

Job Description

Position Description

Lead RaM Mapping Programmer

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, or other healthcare related discipline. Master’s degree is proferred.

Required 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.

• At least 5 years of database development and programming experience, at least 3 of which in clinical database development.

• Proficient in developing and supporting Clinical Data Management System. Including experience with InForm, InForm Architect, Central Designer, and SQL-PL/SQL, XML, Java and Contivo.

• Good experience 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.

Preferred Experience and Skills:

• InForm Architect, Central Designer, Oracle Clinical, DMW, SQL, PL/SQL, C-Sharp.

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We 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 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.

For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.

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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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Under New York City law, the Company is required to provide a reasonable estimate of the salary range for this job. 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 salary range:

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Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R215162