USA - Pennsylvania - West Point, United States of America
Hybrid
Job Description
Position Overview:
Under the direction of the applicable management, the Clinical Data Manager (CDM) is responsible for executing end to end data management activities pertaining to clinical trials, including but not limited to; data management tool and system development, validation and maintenance, data collection, data integrity review and reconciliation, query management, medical coding, and database lock preparation, in compliance with our Company's Standard Operating Procedures (SOPs) and ICH-GCP guidelines.
Primary activities include, but are not limited to:
Participates in the development and change request implementation of data management tools and systems for the clinical trial data management activities under the direction of the SCDM/LCDM
Runs data integrity check reports in accordance with data review plans and relevant SOPs.
Raises questions to investigational site staff and internal and external vendors, reviews responses and corresponding data corrections to confirm identified issue resolution.
Responsible for the execution of user acceptance testing of data management tools under the guidance of the SCDM/LCDM.
Escalates overdue items, including but not limited to outstanding questions and missing visits.
Assists the Senior/Lead CDM with data management activities to resolve all identified data issues prior to study database lock.
Complete trial level archiving activities under the direction of the SCDM/LCDM including, but not limited to, filing of essential documentation.
Maintains compliance with standard key performance indicators according to process expectations at the protocol level.
Monitors data quality and cycle-time performance measures to maintain compliance, performs root cause analysis and implements action plans as needed.
Proactively communicates with Senior/Lead CDM to share project status, risk assessment and outstanding item resolution status.
Qualifications, Skills & Experience:
High School Diploma (or equivalent).
Preferred B.A. or B.S. degree, in Medicine, Pharmacy, Nursing, Biological Sciences, or health care related discipline.
Knowledge and Skills:
Self-motivated, excellent in work planning and time management.
Fluent oral and written English skills.
Good sense and awareness of regulations and policies.
Able to work under pressure and in a changing environment with flexibility.
Good communication skills with the ability to communicate with both the technical and business areas.
MSJR
GDMS
clinicaltrialjobs
eligibleforERP
Required Skills:
Adaptability, Analytical Problem Solving, Clinical Data Cleaning, Clinical Data Management, Communication, Data Analysis, Data Documentation, Data Entry, Data Processing, Data Quality, Data Reporting, Data Review, Data Validation, Data Visualization, Good Clinical Practice (GCP), Root Cause Analysis (RCA), TeamworkPreferred Skills:
Adobe Acrobat, Adobe Forms, Adobe Sign, Microsoft Applications, Microsoft Excel, Microsoft Office, Microsoft Windows, VLOOKUP FunctionCurrent 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:
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
$71,900.00 - $113,200.00This 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
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:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
N/AJob Posting End Date:
06/23/2026*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.
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