Senior Clinical Data Base Developer

Job Description

Our IT Team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation.

We are seeking a Growth and Improvement minded Senior Clinical Data Base Developer that can help drive our Strategic Operating Priorities.

• Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs

• Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)

• Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape

• Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world

• Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us

Summary, Focus and Purpose

The Senior Clinical Data Base Developer (Senior CDBD) assumes the responsibilities for Clinical Database Development deliverables including database set-up and edit check programming to support multiple clinical programs. You will drive the clinical database design activities for startup of a protocol which include design and implementation of clinical database for electronically captured data and participate in the review of eCRFs and edit checks, database development, programming of edit checks, review the technical feasibility of study team proposed edit checks and technically implement them.

The successful candidate works effectively among the Clinical Database Services Team to communicate issues and ideas to improve the business, interact with members of study teams, including external CROs/Vendors where applicable, to integrate study team requirements into all deliverables and supports technical investigation and resolution of clinical database issues.

Under proper change management, responsible for change requests and incidence correction for clinical databases and provides technical and impact analysis support for change requests.

Key Functions

• Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion

• Leads and participates in extra activities including, but not limited to, improvement task forces, automations, 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 and when necessary, complete development activities such as database development or Peer Review

• Provides oversight to Clinical Database Developers

• Participates in mentoring and training of new hires and ongoing technical development of Clinical Database Developers

• Provides input into the performance appraisals of Clinical Database Developers to management

• Ensures the adherence to standards in the development, documentation and maintenance of data dictionaries

• Increases functional effectiveness by supporting departmental efforts to simplify and standardize procedures to the greatest extent possible, sharing best practices and leading continuous improvement efforts

Education

• Required | Bachelor of Arts or Science degree

• Preferred | Bachelor degree in computer science, information technology, life-sciences, or other healthcare related discipline or with relevant experience and skills

Experience | Skills | Knowledge

Required

• Educational exposure to software design, procedure language, development theory and techniques, testing methodologies, and software documentation

• At least 5 years of database development including EDC trial build, C#, SQL, PL/SQL and programming fundamentals experience

• 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

• Principled and effective communicator in written and verbal form with proven ability to maintain productive, customer focused working relationships with both technical and non-technical areas

• Motivation to continuously learn and innovate and has participated on cross-functional process and technology improvement initiatives

Preferred

• JAVA, VB Scripting, Python, AI, Oracle Clinical, MediData,InForm, DMW design and development skills

• Working experience applying CDISC CDASH standards

• Possesses knowledge and understanding of clinical development, FDA regulations (21 CFR Part 11), and GCP/ICH guidelines

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.

#OneGDMS

#EligibleforERP

MRLGCTO

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.

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.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

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, Washington State and California State 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:

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

Learn more about your rights, including under California, Colorado and other US State Acts

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R225484