Job Abstract

Job Description

Primary activities include, but are not limited to:

• Responsible for clinical database design and development activities supporting startup of a clinical trial.

• Activities supported may include standards technical component development and the design and implementation of the clinical study database.

• Reviews technical feasibility of proposed forms, edit checks, data reports and other database capabilities used for review, cleaning and verification activities of clinical data captured in clinical trials and technically implements them.

• Under proper change management, responsible for change requests and incidence correction into clinical database.

• Ongoing support in a dynamic and matrix organization. Works effectively among Clinical Database Services (CDS) staff to communicate issues and ideas to improve quality and efficiency.

• Participate in extra activities including, but not limited to, study improvement task forces, automations, initiatives, testing of new systems, and ongoing training and mentoring.

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.

Qualifications, Skills & Experience

• A minimum of 2 years of database development and/or data cleaning programming experience, procedure language, development theory and techniques, testing methodologies, and software documentation

• Demonstrated strong technical proficiency in SQL or PL/SQL, C#.

• Preferably have other programming languages like Python, Java knowledge and experience.

• Desire and ability to learn new processes and technologies.

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

• 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.

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

#EligibleforERP

MRLGCTO

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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 separationpackage, 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 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”.

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Expected salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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