Senior Specialist, Clinical Data Management, Hybrid

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

1. Execute COA systems development process from Kickoff to system go live, ongoing system change control, system closeout and database lock activities.

2.-Defines/redesigns COA development processes across vendor base. Identifies areas for process improvement and leads improvement activities

3.-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

4.-Performs peer-review of the COA systems specific documentations for quality (e.g. comparing paper COA measures with Developer version etc.)

5.-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.

6.-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.

7. 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.

8.-Provides support for successful integration of our Company and vendor systems.

9.-Provides support for problem resolution between COA vendors and our Company's Clinical Trial Team.

10.-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.

11.-May provide support for the development / maintenance of relevant documentation, including applicable SOPs, job aids, and guidance documentation.

12.-May mentor new staff.

13.-May lead a continuous improvement special project or any other project or perform any other COA related task deemed appropriate by management.

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Education: -

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

Experience:

• 6 years' experience in Clinical Data Management with at least 4 years' of COA working experience

Knowledge and Skills: -

• 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 to 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

Required Skills:
Change Management Training, Clinical Data Management, Clinical Development, Process Improvements, Project Management, Project Risk and Issue Management, Regulatory Compliance, Stakeholder Communications, Third Party Vendor Management, User Acceptance Testing (UAT)

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:

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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.

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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):
N/A

Job Posting End Date:
06/15/2026
*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: R401896