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Associate Director, Clinical Data Management, Hybrid

$142.4k - $224.1k

Merck

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. The Principal Trial Manager is also responsible for leading and/or representing data management functional areas or GDMS in cross‑functional initiatives and project teams as deemed appropriate. They 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 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: 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 -OR- Associates Degree with at least 7 years' professional experience in clinical data management -OR- High School Diploma (or equivalent) with at least 10 years' professional experience in clinical data management 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 Required Skills: Audit Readiness Clinical Data Management Communication Cross-Functional Leadership Data Standards GxPs Inspection Readiness Mentor Coaching Process ImprovementsProject Management Regulatory Experience Risk Management 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. 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. 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. The salary range for this role is $142,400.00 - $224,100.00. 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 The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. 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 07/16/2026 Requisition ID

R405313

#J-18808-Ljbffr Merck & Co.

Vacancy posted 2 days ago
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