RaM Mapping Programmer II
RaM Mapping Programmer II
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.
Our 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.
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 preferred.
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 2 years of database development and programming experience, at least 1 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.
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.
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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.
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Expected salary range:$80,320.00 - $126,500.00
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