Associate Director, Clinical Data Management, Hybrid

MSD • Atlanta, PA

4d • Hybrid

About The Position

The Principal Trial Manager (PTM) 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 PTM will interact with Trial Managers as a Subject Matter Expert (SME), Mentor, and Trainer within areas of expertise and provide project leadership to help develop knowledge within the department. The PTM 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. They will be responsible for leading and/or representing data management functional areas or GDMS in cross-functional initiatives and project teams as deemed appropriate. Principal 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 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, and all required activities outlined in the TM job description.

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 -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 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

Nice To Haves

• Audit Readiness
• Clinical Data Management
• Communication
• Cross-Functional Leadership
• Data Standards
• GxPs
• Inspection Readiness
• Mentor Coaching
• Process Improvements
• Project Management
• Regulatory Experience
• Risk Management

Responsibilities

• 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

Benefits

• medical
• dental
• vision healthcare
• other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Senior