Associate Director, Data Management

1 day ago

Cambridge, United States Prometrika LLC Full time
Job DescriptionJob Description

PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the innovations we help bring to market. Our clients include national and international biopharmaceutical and medical device companies of all sizes.

RESPONSIBILITIES

The Associate Director, Data Management is responsible for supporting the Director, Data Management with the overall DM strategy and implementation for high profile programs, as well as the management and mentorship of DM staff. Provides operational leadership and takes full accountability for the direction, execution, design, collection and handling of all clinical data to the highest quality standards.

FUNCTION MANAGEMENT/LEADERSHIP

  • Lead and mentor a team of Data Managers and provide oversight in all data management activities for multiple clinical development programs:
    • Work with direct reports to develop and implement individual career development and training plans
    • Assign projects to team members and effectively delegate tasks
    • Plan resources and monitor project status
    • Provide timely constructive feedback and frequent positive reinforcement
    • Prepare and present yearly merit performance reviews
    • Collaborate with team members to facilitate problem solving for complex issues
    • Maintain high employee engagement
    • Utilize proactive management style to ensure team members’ growth and project success
  • Collaborate with Director, Data Management on team development, contributing to department goals
  • Participate in process development
  • Ensure availability of relevant training for direct reports
  • Advise the team and the client on implementation of best practices for CRFs and electronic CRFs) design. Collaborate with the teams to ensure that project deliverables are met on time, effectively and efficiently
  • Ensure timely development and implementation of comprehensive data management plans for phase I through phase IV clinical trials including manual review guidelines, edit check specifications, self-evident correction lists, data/query flow guidelines, etc.
  • Provide input from the data management perspective regarding the design of protocols and case report forms for clinical trials
  • Provide strategic input to the department and company goals
  • Propose and lead key departmental goals and initiatives in collaboration with the Director, Data Management
  • Actively work to foster an environment of collaboration amongst colleagues and external partners
  • Assist in the development and update on an ongoing basis data management SOPs and training manuals
  • Perform other duties as assigned

THOUGHT LEADERSHIP

  • Proactively contribute to PROMETRIKA’s newsletters, thought leadership blogs, and other publications as appropriate
  • Contribute materials and present at Lunch and Learns within PROMETRIKA to cross-train and share Data Management expertise within our organization
  • Find innovative approaches to increase PROMETRIKA’s Data Management footprint within the Life Sciences industry

BUSINESS DEVELOPMENT SUPPORT

  • Actively collaborate and partner with the Innovations team on the implementation of new data management technologies and initiatives that drive PROMETRIKA’s competitive advantage
  • Oversee and/or participate in the validation process of new or upgraded data management software
  • Proactively reach out to and collaborate with Business Development on potential, new opportunities
  • Participate in bid defense meetings, capability presentations, and client audits

EDUCATION/EXPERIENCE

  • Bachelor’s degree in a scientific, technical, computer science or related field
  • Minimum of 10 years of experience in clinical trials is required
  • Minimum of 5 years management experience is required
  • Experience in Phase I-IV clinical trials is strongly preferred

SKILLS

  • Demonstrated expertise in leading and supervising a team of people, and in providing guidance and mentorship
  • Excellent written and verbal communication skills
  • Excellent organizational skills
  • Demonstrated ability to accurately identify and resolve problems
  • Demonstrated ability to effectively manage and assign project resources
  • Excellent leadership and interpersonal skills and ability to work collaboratively cross-functionally and to build credibility and trust inside and outside the Company
  • Knowledge of FDA regulations, GCP Guidelines, UAT, drug development process and practices from study startup to submission
  • Ability to drive strong collaboration and teamwork, effective planning and organizing
  • Ability to demonstrate alignment with PROMETRIKA’s Core Competencies is essential
  • Knowledge of EDC systems is critical

PHYSICAL REQUIREMENTS

Incumbents generally must be able to, with or without accommodation, have the proficient use of both sensory perception/clarity and muscle control/coordination. This may include vision (near, far, color, glare control), hearing (auditory attention, sound localization), speech, strength, agility, dexterity flexibility, steadiness or reaction time.


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