Principal Trial Manager

Job Description

The Principal Trial Manager is responsible for leading projects and initiatives to improve the quality and compliance of the data management functional areas in addition to the regular responsibilities as an individual Trial Manager.

Will interact with Trial Managers as SME, Mentor and Trainer within areas of expertise and provide project leadership to help develop knowledge within the department.

Will be able to work independently or as a team member or leader with equal effectiveness.

The Principal Trial Manager is responsible and accountable for the successful execution of the clinical data management strategy for one or more drug or vaccine trials within the TM role.-Will be responsible for leading and/or representing data management functional areas in cross-functional initiatives and project teams as deemed appropriate. Principle Trial Managers will possess end-to-end data management knowledge with strong project management and leadership skills which are transferable from pipeline to process to special initiatives.

Primary activities include, but are not limited to:

• Lead Special Projects and Initiatives within the team;
• Act as a SME, mentor, and trainer on data management, project management, leadership and other areas of expertise;
• Support Training & Development programs to promote Trial Manager end-to-end proficiency;
• • Support and provide input to the functional process owners / potentially serving as an SME to support process implementation;
• Partner with functional area representatives to assess and promote consistency in the use of database standards and trial design/peer review support as needed;
• Identifies, defines and implements improvements to data collection, data and project management processes and tools;
• Support audits and inspections as necessary;
• Functional & cross-functional special project management;
• Complex Risk Management;

Education/Experience:

B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline, with at least 6 years' experience in Clinical Data Management or a mix between Data Management and Clinical Research and at least 3 years' experience working with formal project management tools and processes.

Knowledge and Skills:

• Experience in Oncology Therapy Area is required.
• Demonstrated accomplishments through all phases of the Study Life Cycle.

• Proficient overall working knowledge on the clinical development process.

• Knowledge of applicable regulations and policies.

• Be able to work under pressure in a changing environment with flexibility.

• Ability to work independently and accept and act with appropriate accountability with minimal guidance by management.

• Ability to coordinate the work of others and drive decision making.

• Exceptional communication skills (oral and written) with the ability to communicate with both the technical and business areas.

• Exceptional demonstrated organizational, problem-solving and negotiating skills.

• Demonstrated excellent project management and leadership skills.

• Demonstrated ability to coach and mentor others.
• Demonstrated ability to lead a cross functional Initiative with broad impact to Quality and Compliance

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Required Skills:
Adaptability, Adaptability, Clinical Database Programming, Clinical Data Management, Clinical Data Standards, Clinical Development, Clinical Research, Computer Science, Data Analysis, Data Quality Assurance, Data Reporting, Data Validation, Detail-Oriented, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Interpersonal Relationships, Mentoring Staff, Pressure Management, Project Information Management, Project Leadership, Project Management, Project Management Information Systems (PMIS), Project Management Software (PMS), Project Management Support, Project Management System {+ 2 more}

Preferred Skills:

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Current Contingent Workers apply HERE

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:
No Travel Required

Flexible Work Arrangements:
Hybrid

Shift:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
N/A

Job Posting End Date:
08/11/2026
*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: R410293