Assoc. Dir, Clinical Data Mgmt (Hybrid)

Job Overview Principal Trial Manager — responsible for leading projects and initiatives to improve the quality and compliance of data management across clinical drug and vaccine trials. Works collaboratively with Trial Managers as SME, mentor, and trainer to enhance data management expertise within the department. Responsibilities Execute the clinical data management strategy for one or more drug or vaccine trials. Represent data management functional areas or Global Data Management & Standards (GDMS) in cross‑functional initiatives and project teams. Lead special projects and initiatives within GDMS, acting as SME, mentor, and trainer on data management, project management, and leadership. Support training and development programs to promote trial manager end‑to‑end proficiency. Provide input to functional process owners and serve as SME for process implementation. Partner with functional area representatives to promote consistency in database standards and trial design support. Identify, define, and implement improvements to data collection, data and project management processes and tools. Support audits and inspections as necessary. Manage complex risk, incorporating all activities outlined in the Trial Manager job description. Education & Experience B.A. or B.S. in life sciences, computer science, or related discipline with at least 6 years’ experience in Clinical Data Management or a mix of Data Management and Clinical Research, and at least 3 years’ experience working with formal project management tools and processes. Or Associate’s 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 & Skills Experience working with Contract Research Organizations (CROs) and E2E data management. Experience in the Infectious Disease therapeutic area. Demonstrated accomplishments throughout the study life cycle. Proficient overall working knowledge of the clinical development process. Knowledge of applicable regulations and policies. Ability to work under pressure in a changing environment with flexibility. Strong communication (oral and written) and interpersonal skills. Exceptional organizational, problem‑solving, and negotiating skills. Proven project management and leadership skills. Ability to coach and mentor others and lead cross‑functional initiatives with broad impact on quality and compliance. Required Skills Adaptability Clinical Database Programming Clinical Data Management Clinical Data Standards Clinical Development Clinical Research Data Analysis Data Quality Assurance Data Reporting Data Validation Good Clinical Data Management Practice (GCDMP) Good Clinical Practice (GCP) Interpersonal Relationships Mentoring Staff Project Information Management Project Leadership Project Management Project Management Information Systems (PMIS) Project Management Software (PMS) Project Management Support Project Management System Project Management Tools Project Resource Management Strategic Thinking Preferred Skills Clinical Research Organizations (CRO) Management End to End Management End‑to‑End Planning Benefits Salary range: $142,400.00 – $224,100.00. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable. Benefits include medical, dental, vision, health care and other insurance for employee and family; retirement benefits including 401(k); paid holidays, vacation, and compassionate and sick days. Equal Employment Opportunity Statement We are an Equal Employment Opportunity Employer and provide equal opportunities to all employees and applicants for employment. We 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 United States Equal Opportunity Employment laws, visit the EEOC website. #J-18808-Ljbffr MSD Malaysia