About this role
Essential Functions:
- Provide overall direction of the activities of CDM team members regarding the completion of project deliverables to ensure they are on schedule according to quality standards, requirements, and project budget from study start-up through archival
- Perform Lead Data Management role and/or oversee the performance of other Data Management staff in the planning, database design and execution of several Phase I-IV clinical trials and Real World Evidence projects
- Assist in the development of Standard Operating Procedures (SOPs)
- Ensure staff receives proper and adequate department SOP training, study / protocol-specific training, and job skills training
- Develop and conduct training for new employees; mentors and assists junior level staff
- Monitor quality of work performed by the project team and ensures compliance with SOPs
- Recommend alternative work processes to improve the quality or speed of customer deliverables and responds to questions on Clinical Data Management processes, timelines, and quality
- Manage and communicate project progress, staffing, and resource allocation to the Director or Assistant Director, Clinical Data Management, as needed
- Provide overall direction of the activities of CDM team members regarding the completion of project deliverables to ensure they are on schedule according to quality standards, requirements, and project budget from study start-up through archival
- 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 being communicated
- 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
- Continuously evaluate timelines in relation to work completed and communicate the impact on milestones to CDM management, project team members and sponsor
- Maintain CDM project budget by identifying CDM activities outside the scope of contracted work, obtaining agreement from sponsor or CTI management prior to performing out of scope tasks, preparing, or reviewing budget and cost analysis documentation routinely and following scope issues through to resolution
- Prepare in advance for internal and external meetings, complete action items within required timeframe and attends internal meetings regularly, providing input, and demonstrating respect for opinions of others
- Conduct a post-mortem analysis after study completion to determine positive and negative factors affecting the project and provide this information along with study metrics to CDM management
- Conduct regular meetings with Clinical Data Management staff
- Provide direct supervision, guidance and mentoring to Clinical Data Management staff while encouraging independence and refining of skills of staff
Competencies:
- Demonstrated ability to lead project teams
- Base background/knowledge of the drug development and clinical research process
- Excellent written and communication skills
- Ability to work independently and be self-motivated
Required Education/Experience:
- BA/BS in Life Sciences with at least 6 of experience in Clinical Data Management
or a Masters degree with at least 4 years of experience in Clinical Data Management
- 2 years of relational database experience
- Experience with Data Management systems including Medidata Rave, Anju TrialMaster, Merative Zelta, and Viedoc
- Experience providing knowledge of regulatory guidelines