Senior Specialist, Lead Database Programmer - Clinical Database Services

at Merck in Dover, Delaware, United States

Job Description

Job Description

Activities may include, but are not limited to:

+ 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 into the Clinical Data Management System (CDMS)

+ Leads and participates in the review of electronic case report forms (eCRF) and edit checks, database development, programming of edit checks, and scripts to aid in transfer of electronic data files into the Clinical Data Management System (CDMS).

+ Interface with members of study teams, including external CROs/Vendors where applicable, to integrate study team requirements into all deliverables.

+ Leads and participates in developing transformation logic, and scripts to aid in the flow of data downstream for Analysis and Reporting.

+ Interface with CDS 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.

+ 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.

+ Participates in extra activities including, but not limited to, task forces, 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.

+ Assist clinical database manager/supervisor in project planning, manpower projections and resource allocations across therapy areas. Interface with clinical database manager/supervisor to assure consistency of technical and process strategies across all therapy areas.

Minimum education required:

+ Bachelor’s degree in computer science or equivalent professional experience to software design, procedure language, development theory and techniques, testing methodologies, and software documentation.

Required experience and skills:

+ Minimum 4 years of database development or data programming experience (Oracle PL/SQL).

+ At least 2 years of clinical databases development or programming experience.

+ Demonstrated strong technical proficiency in a Clinical Data Management Systems (i.e., Inform, Inform Architect, Central Designer, Medidata Rave).

+ Solid knowledge of MS Windows/Office software and exposure to web-based applications.

+ Ability to establish and maintain good working relationships with different functional areas.

+ Strong sense of urgency and customer focus.

+ Project Management skills * Ability to present in a group environment.

+ Leadership, verbal and written communication, interpersonal and organizational skills

+ Desire and ability to learn new processes and technologies.

+ Broad knowledge of Clinical Development and Regulatory Affairs requirements

+ Ability to multi-task, work independently, and good communication skills.

+ Understanding of drug discovery process, FDA regulations, GxP guidelines, ICH guidelines, clinical database cleaning process, and 21 CFR Part 11.





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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.

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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 fo

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Job Posting: JC251059915

Posted On: Nov 11, 2023

Updated On: Jan 27, 2024

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