Merck & Co, Inc

Sr. Spclst, Clinical Data Mgmt

Merck & Co, Inc • $117K — $184K *
West Point, PA 19486In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • 6+ years in Clinical Data Management, including 4+ years with COA experience
  • Deep understanding of COA systems development processes
  • Familiarity with the clinical development lifecycle, preferably through submission
  • Expertise in clinical data management practices
  • Strong written and verbal communication capabilities
  • Must be adept at multitasking and meeting deadlines in a dynamic environment

Responsibilities

  • Gather study-specific user requirements and manage project timelines
  • Monitor system change requests and act as COA systems subject matter expert
  • Enforce COA processes and resolve issues or deviations
  • Lead process improvement initiatives in COA system development
  • Manage vendor performance and relationships effectively
  • Facilitate stakeholder communication and risk escalations
  • Develop and enforce COA systems standards and documentation

Benefits

  • Hybrid work arrangement for flexibility
  • Focus on professional development with opportunities for training
  • Possibility to participate in mentorship programs
  • Engagement with diverse projects fostering career growth
  • Access to a supportive and inclusive company culture
Full Job Description
Job Description

COA Sr. Specialist is responsible for providing end-to-end COA systems project management support including, but not limited to:
  • Gathering study-specific user requirements, executing UAT tasks, managing project timelines, managing and enforcing COA systems Standards.
  • COA Sr. Specialist also monitors system change requests and acts as our Company's COA systems subject matter expert while liaising with external vendors.
  • Accountable for making decisions regarding COA process, issue resolution, and deviations from standards.
  • Applies COA systems expertise on day-to-day activities when issues are escalated.
  • Communicates with internal and external stakeholders and escalates risks.
  • May participate and lead in process improvement initiatives, standards development and maintenance.
  • Responsible for creating and enforcing COA systems standards, managing vendor performance, and supporting training &education of stakeholders.


Primary Activities
  • Execute COA systems development process from Kickoff to system go live, ongoing system change control, system closeout and database lock activities.
  • Defines/redesigns COA development processes across vendor base. Identifies areas for process improvement and leads improvement activities
  • Creates and enforces the use of COA systems standards. Responsibilities may include creation / revision of COA systems standards, collaboration with vendors and internal stakeholders to define requirements, and monitoring standards utilization rate
  • Performs peer-review of the COA systems specific documentations for quality (e.g. comparing paper COA measures with Developer version etc.)
  • Manages vendor performance and relationship(s). Responsibilities may include defining and implementing process with vendor representatives, monitoring and analyzing vendor and our Company's performance metrics, performing root cause analysis and identifying corrective actions, and serving as point of escalation for vendor issues.
  • Serves as project manager of all COA systems activities for protocols assigned. Uses interpersonal, negotiating, and project management skills to perform the following tasks:
    - Project plan development, execution, and change control. Coordinates resolution & risk mitigation of all COA systems related issues and end of study vendor deliverables
    - Activity definition and sequencing, duration estimation, schedule development, and schedule control.
    - Risk management planning (i.e., risk identification, analysis, and response planning, as well as risk monitoring and control).
    - Communication planning, information distribution, performance reporting, and project closure.
  • Obtains internal and external stakeholder feedback; this may include meeting with vendor project managers and/or meeting with subject matter experts or representatives from stakeholder functional areas.
  • Provides support for successful integration of our Company and vendor systems.
  • Provides support for problem resolution between COA vendors and our Company's Clinical Trial Team.
  • May participate in training and education for stakeholders. May develop, or assist in development of, reference and/or training material. May provide cross-functional internal and external communication as needed.
  • May provide support for the development / maintenance of relevant documentation, including applicable SOPs, job aids, and guidance documentation.
  • May mentor new staff.
  • May lead a continuous improvement special project or any other project or perform any other COA related task deemed appropriate by management.


Education:
  • B.A. or B.S. degree, preferably in life sciences, computer science, engineering or related discipline.


Required Experience and Skills:
  • 6 years' experience in Clinical Data Management with at least 4 years' of COA working experience
  • Demonstrate knowledge of COA systems development processes
  • Knowledge of the clinical development process, preferably through submission.
  • Thorough knowledge of clinical data management
  • Effective written and verbal communication skills
  • Ability independently perform and manage multiple tasks at one time and meet deadlines in a complex environment working both internal to our Company and external to our Company.


#eligibleforERP
#clinicaltrialjobs

#GDMS

Required Skills:
Adaptability, Clinical Data Management, Clinical Information Systems, Communication, Data Validation, Good Clinical Practice (GCP), Project Management, Stakeholder Analysis, Standards Compliance, Teamwork, Vendor Management

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.

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:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
N/A

Job Posting End Date:
09/2/2026
*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.

About Merck & Co, Inc

Schering-Plough Corporation is a major U.S.-based manufacturer of pharmaceuticals. It operates in three segments: Prescription Pharmaceuticals, Animal Health, and Consumer Health Care. Schering-Plough develops products targeting on allergy, cancer, hepatitis, cardiovascular, central nervous system, respiratory system, and more.  It was founded in 1851 by Ernst Christian Friedrich Schering as Schering AG in Germany. Schering-Plough manufactured several pharmaceutical drugs, the most well-known of which were the allergy drugs Claritin and Clarinex, an anti-cholesterol drug Vytorin, and a brain tumor drug Temodar. It also developed drugs targeting on central nervous system and the respiratory system. Schering Plough also owned and operated the major foot care brand name Dr. Scholl's and the skin care line Coppertone. These also became a part of the new company. Schering-Plough was a full member of the European Federation of Pharmaceutical Industries and Associations (EFPIA), a membership which is also maintained by the new Merck.

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Join the visionary team at Merck & Co, Inc, a global leader in healthcare dedicated to advancing the world of medicine. As part of our professional community, you'll find dynamic job opportunities that foster innovation and leadership across various fields. Merck & Co, Inc is not just a company; it's a place where you can make a difference.

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We understand that our employees are our greatest asset, which is why we offer competitive benefits designed to support the health and well-being of you and your family. From comprehensive health care coverage and retirement plans to flexible working conditions and wellness programs, our benefits package is designed to meet the diverse needs of our team members.

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Learn more about Merck & Co, Inc
Size
68,000 employees
Market Cap
$282.6 billion
Industry
Pharmaceuticals & Biotech
Net Income
$7 billion
Founded
1668
5 Year Trend
+4.1%
Revenue
$47.9 billion
NASDAQ
MRK
* Ladders Estimates

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