Hiring company: Merck
Job Description
New hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.
Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
Primary Responsibilities
- 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:
- Responsible for the clinical database design activities for startup of a protocol which include design and implementation of clinical database for electronically captured data.
- Participates 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 implements them.
- Work effectively among team to communicate issues and ideas to improve the business.
- Interface with members of study teams, including external CROs/Vendors where applicable, to integrate study team requirements into all deliverables.
- Supports technical investigation and resolution of clinical database issues.
- Under proper change management, responsible for change requests and incidence correction for clinical databases.
- Provides technical and impact analysis support for change requests.
- Participate in extra activities including, but not limited to, study improvement task forces, automations, initiatives, testing of new systems, training and mentoring.
- Ongoing support in a dynamic and matrix organization.
Education Minimum Requirement
- B.A. or B.S. degree, preferably in computer science, information technology, life-sciences, or other healthcare related discipline.
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 2-4 years of database development including C#, Java, SQL, PL/SQL programming experience; EDC build experience (InForm).
- 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.
Preferred Experience and Skills
- InForm Architect, Central Designer, Oracle Clinical, MediData, 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.
#EligibleforERP
#MRLGCTO
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And 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., Kenilworth, 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.
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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.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
Shift:
Not IndicatedValid Driving License:
Hazardous Material(s):
Number of Openings:
1