Peachtree BioResearch Solutions is hiring a
Director Clinical Data Management in United States

Summary

Peachtree BioResearch Solutions is seeking a Director, Clinical Data Management. This is a fully remote position open to US-based candidates. The selected individual will manage a data management team, mentor staff, provide leadership, support bid defense activities, and ensure compliance with regulations and standards.

Requirements

• Minimum 10 years clinical data management experience, preferably in pharmaceutical research and development or related field
• 5 years managerial experience
• Bachelor’s degree, preferred
• Experience with a variety of EDC systems
• Working knowledge of medical terminology, federal regulations, Good Clinical Practice, CDISC standards and Good Clinical Data Management Practices
• Prior experience leading large-scale initiatives involving developing, documenting, and training data management processes, practices, and procedures
• Excellent communication, organization, problem solving and project management skills
• Experience and ability to work independently, as well as handle several diverse projects simultaneously, under tight time constraints
• Ability to engage and demonstrate cooperative behavior to lead team efforts
• Experience in responding rapidly to changing priorities and in managing aggressive deadlines
• Excellent written and verbal communication skills. Extensive experience in communicating with all levels of personnel, in domestic and international environments
• Demonstrated experience in leading and participating in collaborative work teams
• Strong leadership abilities and interpersonal skills
• Proficiency in English
• Ability to travel, both domestically and internationally, as the business necessitates

Responsibilities

• Manage a data management team that performs the activities associated with the acquisition, documentation, review, cleaning, and processing of clinical data
• Act as a single consistent liaison between the Sponsor Company and all other data management staff allocated to the project
• Mentor data management staff to foster efficient collaboration with all interfaces and ensure the delivery of reliable and comprehensive databases in a timely fashion
• Provide leadership and direction to other managers by establishing clear directives and communicating team goals
• Support Bid Defense activities, serving as a subject matter expert for data management
• Ensure that processes, SOPs, and standardized training/tools exist to facilitate consistent, efficient, and compliant data management deliverables
• Managing the responsibilities associated with the acquisition, documentation, review, cleaning, and processing of clinical data collected for marketed and investigational drugs, in clinical trials
• Establishing and measuring quality performance targets for CDM activities
• Ensuring the accuracy and consistency of Case Report Forms and databases designed according to Sponsor specifications, and Clinical Protocol
• Reviewing the Data Management documentation while ensuring consistency with the Clinical Trial Protocol and are in compliance with internal or sponsor procedures, international or national regulations and Good Clinical Practices
• Projecting, planning, developing, implementing, and delivering quality results in a timely manner. Coordinating and managing the activities of a CDM trial team
• Participating in Clinical Data Management initiatives, to contribute to the continuous improvement of the processes and technologies utilized within the department
• Ensuring Data Management tasks are performed according to the schedule of services, which describes the specific CDM activities and timeframe for completion, contracted with the Sponsor Company and other data vendors, while ensuring adherence to federal regulations, Good Clinical Practice and Good Clinical Data Management Practices
• May be required to act as the leading study data manager

Benefits

• Medical, Dental, Vision coverage (Company contributes significantly to premiums)
• 20 days PTO + 13 Paid Holidays
• 100% employer matching 401(k)
• Short & Long-term disability benefits