Associate Specialist, Clinical Data Management

Merck & Co.

West Point (PA)

Hybrid

USD 72,000 - 113,000

Full time

3 days ago

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Benefits offered by this job

401(k) retirement benefits

Paid holidays, vacation and sick days

Hybrid work arrangement

Job summary

Merck & Co., Inc. is seeking a Clinical Data Manager (CDM) in the West Point, PA area.

You will oversee end-to-end data management activities for clinical trials, including tool development, data integrity review, query management, coding, and database lock preparation, while adhering to SOPs and ICH-GCP guidelines. Key responsibilities include implementing data management tools, running integrity reports, and coordinating with sites and vendors.

Qualifications

End-to-end data management for clinical trials.
Knowledge of SOPs and ICH-GCP guidelines.
Ability to work under pressure in a changing environment.

Responsibilities

Develop and implement data management tools and change requests under guidance.
Run data integrity check reports per data review plans.
Raise questions to sites/vendors and verify data corrections.
Execute user acceptance testing of data management tools.
Monitor data quality and cycle-time, escalating issues as needed.
Support study database lock preparation and archiving activities.

Skills

Adaptability

Analytical Problem Solving

Clinical Data Cleaning

Clinical Data Management

Data Collection Methods

Data Documentation

Data Integrity

Data Processing

Data Reporting

Data Review

Data Validation

Document Management

Good Clinical Practice (GCP)

Project Management

Teamwork

Education

High School Diploma

B.A. or B.S. in Medicine/Pharmacy/Nursing/Biological Sciences/Health care

Job description

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.--

Education Requirement

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

Required Skills

Adaptability
Analytical Problem Solving
Clinical Data Cleaning
Clinical Data Management
Data Collection Methods
Data Documentation
Data Integrity
Data Processing
Data Reporting
Data Review
Data Validation
Document Management
Good Clinical Practice (GCP)
Project Management
Teamwork

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.

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 primary location for this posting is:

USA - Pennsylvania - West Point

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

$71,900.00 - $113,200.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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 .

Additional location(s):

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

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

Travel Requirements

No Travel Required

Flexible Work Arrangements

Hybrid

Shift

1st - Day

Valid Driving License