Associate Director, Document Management

Summary of Responsibilities

The Associate Director, Document Management (AD, Doc-M) is responsible for the strategic and tactical operations of the Document Management Department and is a leadership position. The AD effectively manages all aspects of Document Management, including hiring, training and coaching of Doc-M staff. This individual serves as a subject matter expert (SME) for effective document lifecycle management in an electronic TMF environment, including ensuring the quality and compliance of trial master file (TMF) plans, procedures, and content. The AD, Doc-M participates in relevant business development opportunities, project scope and budget activities, and provides oversight to achieve and maintain TMF inspection-readiness through cross-functional collaboration and analysis of key performance indicators related to clinical trial documentation and the electronic TMF (eTMF) system.

Essential Functions

  • Operational Document Management Responsibilities
    • Understand Advanced Clinical's overall financial plan and contribution in supporting corporate strategic goals.
    • Maximize department productivity to exceed AC budget goals.
    • Supervise and ensure the efficient work and productivity of Document Management team members.
    • Identify and implement process improvements and strategies in Document Management.
    • Hire, mentor, monitor and supervise Doc-M team members.
    • Ensure Doc-M team members are qualified through experience and appropriate training.
    • Understand and manage resourcing demand and capacity for the department.
    • Make appropriate and timely resourcing assignments to projects.
    • Manage employee performance, and conduct periodic performance evaluations for direct reports.
    • Ensure development of, and adherence to, project-specific TMF Plans.
    • Understand project deliverables and ensure Doc-M related milestones are met (in addition to supporting other project related deliverables).
    • Ensure staff are meeting defined workload and quality metrics through regular review and reporting of findings.
    • Prepare for, and participate in, internal or external audits/inspections, including facilitation of inspector access to TMFs and support audit responses as required.
    • Serve as subject matter expert for TMF related topics (e.g. content, systems and processes).
    • Monitor and analyze key performance indicators (i.e. metrics) related to team member productivity, production of quality work output and eTMF system use.
    • Demonstrate technical and strategic knowledge of applicable regulatory requirements, including electronic technology industry standards, e.g., 21CFR11, etc., and contribute to development and review of Standard Operating Procedures.
    • Perform other duties as requested by management.
  • Business Development Responsibilities
    • Assist with RFP/RFI completion
    • Attend sales meetings as requested by Business Development.
    • Provide input into budgeting assumptions for items related to Document Management.

Education
  • Bachelor's degree in a health-care or scientific discipline with 6 years of industry experience working with clinical trial documentation and 4 years of experience in a senior leadership capacity; or equivalent combination of education, training and experience.

Training
  • On the job or professional training in ICH GCP and regulatory records management required. Familiarity with clinical systems including electronic content management systems strongly preferred

Experience:

The ideal candidate should have:
  • Exceptional leadership skills and proven industry experience.
  • Efficient and effective time management skills with ability to successfully drive and manage competing priorities.
  • High level of attention to detail and commitment to follow through.
  • The ability to establish and maintain effective working relationships with executive management, coworkers, managers and clients.
  • Excellent organizational and problem solving skills.
  • Advanced knowledge of, and ability to apply GCP/ICH and all applicable regulations and guidelines.
  • Advanced knowledge of TMF industry standards, including TMF Reference Models.
  • Superior written and verbal communication skills including excellent command of English with computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.
  • Ability to travel, as required, up to 20%
  • Certification - None required. Certification in an electronic content management system preferred.

Advanced Group is proud to be an Equal Opportunity Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, disability, sexual orientation, ancestry, marital or veteran status.


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