Associate Director, Clinical Data Management, Hybrid

Overview Principal Trial Manager (PTM) leads projects and initiatives to improve the quality and compliance of data management activities, in addition to the standard responsibilities of a Trial Manager. The PTM serves as a SME, mentor and trainer within data management and project leadership, and can work independently or as a team member or leader with equal effectiveness. The PTM is responsible for the successful execution of the clinical data management strategy for one or more drug or vaccine trials within the Trial Manager role, and may lead or represent data management functional areas or GDMS in cross-functional initiatives and project teams. Principle Trial Managers possess end-to-end data management knowledge with strong project management and leadership skills, transferable from pipeline to process to special initiatives. Responsibilities Lead special projects and initiatives within GDMS Act as 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 functional process owners and potentially serve as an SME to support process implementation Partner with functional area representatives to promote consistency in the use of database standards and trial design/peer review support as needed Identify, define and implement improvements to data collection, data management, and project management processes and tools Support audits and inspections as necessary Engage in functional and cross-functional special project management and complex risk management Qualifications and Experience B.A. or B.S. degree (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 with formal project management tools/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 Demonstrated accomplishments through all phases of the Study Life Cycle Proficient knowledge of the clinical development process Knowledge of applicable regulations and policies Ability to work under pressure in a changing environment with flexibility Ability to work independently with appropriate accountability and minimal guidance Ability to coordinate the work of others and drive decision making Exceptional communication skills (oral and written) with the ability to communicate with both technical and business areas Strong 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 GxP Inspection Readiness Mentor Coaching Process Improvements Project Management Regulatory Experience Risk Management Preferred Skills Current Employees apply here Current Contingent Workers apply here EEO statements and benefits: Our company is committed to inclusion, providing equal opportunities to all employees and applicants and prohibiting discrimination based on race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other protected characteristics. As a federal contractor, we comply with affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights, visit EEOC resources. The salary range for this role is $142,400.00 - $224,100.00. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive benefits package, including medical, dental, vision, retirement benefits, paid holidays, vacation, and sick days. More information about benefits is available at the company careers site. Applicants can apply online via the company website or Workday Jobs Hub. The application deadline is posted on the job posting. #J-18808-Ljbffr MSD Malaysia