Assoc. Dir, Clinical Data Mgmt (Hybrid)

MSD • Rahway, NJ

1d • Hybrid

About The Position

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 (TM). They 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. Will be responsible for leading and/or representing data management functional areas or Global Data Management & Standards (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. Primary activities include, but are not limited to: Lead Special Projects and Initiatives within Global Data Management & Standards (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 Trial Manager 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.
• Associate's degree with at least 7 years’ professional experience in clinical data management.
• High School Diploma (or equivalent) with at least 10 years’ professional experience in clinical data management.
• Knowledgeable in working with Contract Research Organization (CROs) E2E data management.
• Experience in Infectious Disease Therapeutic Area.
• 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.
• 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

Nice To Haves

• Clinical Research Organizations (CRO) Management
• End to End Management
• End-to-End Planning

Responsibilities

• Lead Special Projects and Initiatives within Global Data Management & Standards (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 Trial Manager job description.

Benefits

• medical, dental, vision healthcare and 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: Director