Associate Director, Clinical Data Management

Merck Gruppe - MSD Sharp & Dohme; Rahway (NJ); On-site; USD 130,000 - 190,000; Full time

Job summary

Merck Gruppe - MSD Sharp & Dohme seeks a Principal Trial Manager to lead data management initiatives, drive quality and compliance, and supervise cross-functional trial teams across drug or vaccine trials. You will mentor others, coordinate PM activities, and partner with functional area reps to ensure high standards in database design and trial execution.

The role requires end-to-end data management knowledge and strong leadership to oversee complex projects, risk management, and QA activities

Qualifications

• B.S. in life sciences or related discipline; strong background in clinical data management.
• Experience with project management tools and processes; able to lead cross-functional teams.
• Knowledge of GCP/regulatory requirements and quality/compliance expectations.

Responsibilities

• Lead and manage data management projects and initiatives within GDMS.
• Act as SME, mentor and trainer on data management, PM and leadership topics.
• Support and input to process owners; promote consistency in database standards and trial design support.
• Identify and implement improvements to data collection, data management processes and tools.
• Support audits and inspections as necessary; manage complex risk and cross-functional projects.

Skills

Clinical Data Management

Project Management

Leadership

GCP

Communication

Mentoring

Cross-functional Collaboration

Risk Management

Quality & Compliance

Education

Bachelor of Science in Life Sciences/related field

Master’s degree in Life Sciences or related field

Job description

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.

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 or GDMS 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.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 and will be able to work independently or as a team member or leader with equal effectiveness.

Primary activities include, but are not limited to:

• Lead Special Projects and Initiatives within GDMS.
• 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 (PO)/ 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.
• All required activities outlined in the TM job description.

Education/Experience (ex-Us, subject to local requirements):

• 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:

• 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.

clinicaltrialjobs

EligibleforERP

#GDMS

Required Skills:

Ability to Coordinate, Clinical Data Management, Clinical Data Standards, Data Management, Detail-Oriented, Good Clinical Practice (GCP), Influencing Skills, Mentoring Staff, Project Management Leadership, Strategic Thinking

Preferred Skills:

Cross-Functional Teamwork, Decision Making, Deliverables Management, Leadership, Leading Project Teams

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 if you need an accommodation during the application or hiring process.

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:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

No

Job Posting End Date:

08/28/2026

*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:

R413072