Senior Specialist, Clinical Data Management - Hybrid Job at Merck & Co., Rahway, NJ

dzB6UjNDTHRCeUZkMVhwc2JmWit3a2t2UlE9PQ==
  • Merck & Co.
  • Rahway, NJ

Job Description

Job Description

Primary activities include, but are not limited to:
  • 40% Oversees and coordinates clinical database activities for multiple clinical programs.- Interface with CDS manager/supervisor to assure consistency of technical and process strategies. Acts as a technical resource to other members of the group.- Plans appropriately to ensure adherence to timelines.- Interface with members of study teams, including external CROs/Vendors where applicable, to integrate study team requirements into all deliverables.--
  • 20% Creates and develops clinical databases and data transfer files according to written specifications. Ensures adherence to clinical database standards, SOPs and Process Guidelines. Leads and participates in the review of eCRFs and edit checks, database development, programming of edit checks, and scripts to aid in transfer of electronic data files into the Clinical Data Management System (CDMS).
  • 20% Trains new hires and participates in the interview process. Provide ongoing training and development to Clinical Database Developers on existing standards. Helps to develop a customer oriented and can-do attitude in the group and contributes as subject matter expert for trouble-shooting findings.--
  • 15% Leads and participates in extra activities including, but not limited to, task forces, 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.
  • 5% Assist clinical database manager/supervisor in project planning, manpower projections and resource allocations across therapy areas.- Interface with clinical database manager/supervisor to assure consistency of technical and process strategies across all therapy areas.
Education:-
  • A B.A. or B.S. degree, preferably in mathematics, science, a healthcare-related discipline, or computer science; or relevant skills and experience.
Required Experience and Skills:--
  • 4 years of database development or data cleaning programming experience, at least 3 of which including clinical databases and programming.
  • Demonstrated strong technical proficiency in a Clinical Data Management System. Particularly Veeva EDC, Central Designer, SQL-PL/SQL.
  • At least 4 years' experience with Oracle databases and SQL.
  • 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. * Strong sense of urgency and customer focus. * Project Management skills * Ability to present in a group environment * Leadership, verbal and written communication, interpersonal and organizational skills * Desire and ability to learn new processes and technologies * Broad knowledge of Clinical Development and Regulatory Affairs requirements * Ability to multi-task, work independently, and good communication skills * Understanding of drug discovery process, FDA regulations, GxP guidelines, ICH guidelines, clinical database cleaning process, and 21 CFR Part 11.---
clinicaltrialjobs -

EligibleforERP

#GDMS

Required Skills:
Adaptability, Clinical Database Programming, Clinical Data Management, Clinical Programs, Clinical Research, Communication, Data Analysis, Data Quality Assurance, Data Reporting, Data Review, Data Validation, Good Clinical Practice (GCP), Medical Terminology, Project Management, Teamwork

Preferred Skills:

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.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement•

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

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

The salary range for this role is
$117,000.00 - $184,200.00

This 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 .

You can apply for this role through (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

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:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Hybrid

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
No

Job Posting End Date:
08/5/2026
*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.

Requisition ID: R408717

Job Tags

Full time, For contractors, Local area, Relocation, Visa sponsorship, Flexible hours, Shift work

Similar Jobs

SpringHill Suites Orange Beach at The Wharf

Maintenance Technician - Hotel Job at SpringHill Suites Orange Beach at The Wharf

Maintenance Technician - HotelWe are seeking a skilled and reliable Maintenance Technician-Hotel to support the overall upkeep and functionality of our property. This role includes performing routine maintenance, addressing guest requests, and ensuring all systems operate... 

Cherokee County Health and Rehabilitation Center

Clinical Outreach Liaison Job at Cherokee County Health and Rehabilitation Center

 ...Representative to drive our community outreach and healthcare provider partnerships. In this role, you will bridge the gap between clinical care and community engagement-building trust with hospital physicians, guiding families through healthcare options, and... 

Value Fusion

Senior Accounting Manager Job at Value Fusion

 ...Senior Accounting Manager Remote | Full-Time | $90K-$120K Total Compensation About the Role Value Fusion is hiring a Senior Accounting...  ...a multi-client environment ~ Direct experience in a CAS, outsourced accounting, or firm-based client services practice ~ Track... 

NBCUniversal

Sr Publicist-NBC Sports Job at NBCUniversal

 ...global theme park destinations, consumer products, and experiences. We own and operate leading entertainment and news brands, including NBC, NBC News, NBC Sports, Telemundo, NBC Local Stations, Bravo, and Peacock, our premium ad-supported streaming service. We produce and... 

AtWork Personnel Durant OK

Auto Mechanic Job at AtWork Personnel Durant OK

 ...Description We are looking for a dependable and experienced Auto Mechanic to join our team! The ideal candidate will be responsible for diagnosing, repairing, and maintaining a variety of vehicles while providing quality workmanship and excellent customer service....