Specialist, Clinical Data Management - Hybrid
EyeBio
Job Description
Primary activities include, but are not limited to:
Assumes the responsibilities for all clinical programming (including reporting and analytics) deliverables including Oracle, Veeva platforms along with the external data captured in support of the clinical studies.
Coordinates and participates in the following activities:
Design, build, maintain, test, and document data review based on written specifications established by Global Clinical Data Management, Clinical Research and Global Safety.
Review the technical feasibility of study team proposed programming/reporting and technically implements them.
Work effectively among team to communicate issues and ideas to improve the business along with understanding of Protocol .
Support the development & reporting for data cleaning, medical review, clinical monitoring, and safety reports for quality and timely availability in support of our customer needs.
Perform ongoing support for In-Life Reports. Change Requests and Incident Reports are fully documented, signed off, tracked, and reported to upper management.
Participate in extra activities including, but not limited to, study improvement task forces, automations, initiatives, testing of new systems, and ongoing training and mentoring.
Education:
B.A. or B.S. degree, preferably in mathematics, science, a healthcare-related discipline, or computer science; or relevant Pharma skills and experience.
Knowledge and Skills:
4+ years’ experience in a. SQL, PL-SQL, PowerBI
Expected to have a strong technical proficiency in a Clinical Data Management/Reporting
Systems like Databricks, Python, SAS, etc along with AI related tools.
Solid knowledge of MS Windows/Office 365 suit software and exposure to web-based applications.
Solid knowledge of System Development Lifecycle Management / system validation knowledge
Ability to establish and maintain good working relationships with different functional areas.
Strong sense of urgency and customer focus.
Possesses excellent communication skills and interacts effectively with Study Team along with Strong organizational and problem-solving skills.
Desire and ability to learn new processes and technologies
Ability to multi-task, work independently, and good communication skills
Understanding of drug discovery process, FDA regulations, GxP guidelines, ICH
clinicaltrialjobs
EligibleforERP
#GDMS
Required Skills:
Adaptability, Adaptability, Clinical Data, Clinical Databases, Clinical Data Cleaning, Clinical Data Management, Clinical Physiology, Clinical Research, Computer Science, Customer-Focused, Data Analysis, Database Development, Data Processing, Data Quality Assurance, Data Review, Data Validation, Data Visualization, Drug Discovery Process, Electronic Data Capture (EDC), FDA Regulations, Learning Agility, Medical Review, Nephrology, Pathophysiology, Pharmacovigilance {+ 2 more}Preferred Skills:
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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, Monday - 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 salary range for this role is
$87,300.00 - $137,400.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
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Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
1st - DayValid Driving License:
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NoJob Posting End Date:
04/18/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.