Senior Specialist, Lead Database Developer

Job Description

Clinical Database Developer

Are you ready to leverage your skills in a role that plays an integral part in advancing healthcare and touching lives? At our company, we're shaping the future of health. We're seeking a Clinical Database Developer who will be instrumental in creating and developing clinical databases and data transfer files. This role provides a unique opportunity to contribute to a team that is delivering innovative solutions for the prevention and treatment of diseases in both humans and animals.

Your Core Responsibilities

• Your primary role will be to create and develop clinical databases and data transfer files, ensuring they align with written specifications.

• You'll be expected to uphold our clinical database standards, SOPs, and Process Guidelines.

• You will have the opportunity to lead and participate in the review of electronic case report forms (eCRF) and edit checks, database development, programming of edit checks, and scripts that facilitate the transfer of electronic data files into the Clinical Data Management System (CDMS).

• A key aspect of your role will be to collaborate with members of study teams, including external CROs/Vendors, to incorporate study team requirements into all deliverables.

• You will also be involved in developing transformation logic, and scripts that aid in the streamlining of data for analysis and reporting.

• One of the rewarding aspects of this role is the chance to provide ongoing training and development to other Clinical Database Developers on existing standards.

• You will be part of various activities, including task forces, testing new systems, and coordinating CDS technical initiatives.

• Supporting the clinical database manager/supervisor in project planning, manpower projections, and resource allocation across therapy areas will be another key responsibility of yours.

Who You Are

You are ready if you have:

• A bachelor’s degree in computer science or equivalent professional experience in software design, procedural language, development theory and techniques, testing methodologies, and software documentation.

• A minimum of 4 years of database development or data programming experience (Oracle PL/SQL and Object-Oriented Programming).

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

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

• Working knowledge of MS Windows/Office software and exposure to web-based applications.

• A strong sense of urgency and customer focus, coupled with the ability to establish and maintain good working relationships across different functional areas.

• Solid project management skills.

• Excellent leadership, verbal and written communication, interpersonal, and organizational skills.

• A strong desire and ability to learn new processes and technologies.

• Broad knowledge of Clinical Development and Regulatory Affairs requirements.

• The ability to multi-task, work independently, and communicate effectively.

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

#EligibleforERP

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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 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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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”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. 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.

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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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