BA/BS in Life Sciences with 12+ years or Master's degree with 10+ years in Clinical Data Management (CDM)
Experience with Electronic Data Capture (EDC) systems, specifically Medidata Rave and OmniComm TrialMaster
Minimum of 8 years in a direct line management role
Strong understanding of clinical trial conduct regulations and ICH E6 Good Clinical Practice
Knowledge of medical terminology and drug nomenclature
Responsibilities
Support the creation of Clinical Data Management Global Standard Operating Procedures (GSOPs)
Prepare study-specific fee estimates and communicate project progress to stakeholders
Execute resource planning and identify technology needs while mitigating risks
Direct CDM team activities to ensure project deliverables meet quality standards
Supervise and mentor CDM staff to foster independence and skill refinement
Provide timely feedback for performance reviews of project team members
Maintain open lines of communication with internal and external stakeholders
Benefits
Supportive corporate culture that encourages professional development
Opportunities for mentoring and leadership skills enhancement
Engaging role that allows for interaction with clients and stakeholders
Access to advanced data management technology and systems
Dynamic work environment that promotes independence and resourcefulness
Full Job Description
Essential Functions:
Support the development of CDM Global Standard Operating Procedures (GSOPs)
Prepare and defend study specific fee estimates to clients, present CDM capabilities to clients, and communicate project progress, staffing and resource allocation to Senior Director, Data Management
Plan and execute a resource plan that supports the business; identify technology needs or other gaps; identify and communicate risks to the business and develop solution-oriented approaches to address or mitigate risk; trouble-shoot responsibility by resolving critical issues that impact optimal functioning of the team
Provide direction of activities of Clinical Data Management (CDM) team members regarding completion of project deliverables to ensure they are on schedule according to quality standards, requirements, and project budget from study start-up through archival
Provide direct supervision, guidance, and mentoring to CDM staff while encouraging independence and refining skills of staff
Provide effective and timely feedback to management for performance reviews of project team members on an ongoing basis
Maintain open communication with internal and external customers by contacting sponsor counterpart on agreed-upon schedule, responding to correspondence promptly and within agreed upon timeframes, and choosing method of communication based on urgency and type of information including governance calls with Sponsors
Evaluate team requests by considering factors such as efficiency, quality, budget, resources, and customer relations before committing to an action; seek out existing knowledge prior to developing new methods
Competencies:
Excellent verbal and written communication skills
Knowledge of Data Management systems including Medidata Rave, OmniComm TrialMaster, and IBM Clinical Development
Knowledge of regional regulations relative to clinical trial conduct, as well as ICH E6 Good Clinical Practice
Base background / knowledge regarding medical terminology and drug nomenclature
Ability to work independently and be self-motivated
Base background / knowledge of the drug development and clinical research process
Demonstrated ability to lead project teams
Required Education/Experience:
BA/BS in Life Sciences with at least 12 years of experience in CDM or Master's degree with at least 10 years of experience
Experience with EDC systems including Medidata Rave and OmniComm TrialMaster
At least 8 years direct line management experience
