ResearchEd

Data Scientist

• Oversee, lead, manage and provide technical expertise within the assigned projects.
• Provide fully independent and autonomous leadership of data management services (start up, conduct and close out) across multiple complex global projects/programs.
• Ensure appropriate resources are allocated to complete all DM activities on time and budget.
• Prepare DM trial documentation (DMP, DB Specifications, Edit check specifications, CCGs, DTAs).
• Write external vendor reconciliation specifications for programming reconciliation outputs.
• Oversee data cleaning activities.
• Produce metrics to monitor progress of trial activities.
• Ensure all database lock activities are completed on time.
• Represent WorldWide DM at both internal and external study meeting calls.
• Monitor project scope, budgets and risks and alert DM Management of any concerns.
• Liaise with DM Management regularly to discuss progress and issues outstanding.
• Collaborate with internal Worldwide departments working on the same project.
• Provide training, support and mentorship to other members of the DM department.

Senior Clinical Data Manager

Vice President

• Provide executive oversight on multiple clinical research projects and client relationships.
• Provide senior management support for broad-based projects such as NDA submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations.
• Provide advanced technical expertise, in conjunction with internal and external team members, to design, implement, validate, and maintain project reporting applications that are supported by the department.
• Represent the department and company in a multi-disciplinary setting, including project team meetings, client meetings/presentations, bid defense meetings, and be on the podium at industry events.
• Set strategy, develop, lead, and oversee the global department.
• Develop and track metrics on productivity and quality, and create strategies and best practices.
• Hire, supervise, and mentor biostatistics and programming leaders to effectively manage projects and staff.
• Develop and maintain Standard Operating Procedures and other departmental processes and procedures in accordance with guidelines and regulations to ensure quality deliverables.
• Drive commercial growth for the business and partner with commercial colleagues effectively.
• Provide strategic input to technology for current and future state.
• Develop study-specific bids that demonstrate an understanding of each client’s needs in a creative, innovative, efficient, and effective manner.
• Oversee operational execution of biostatistics and programming activities within the scope of the contract.
• Maintain an awareness of project issues and support teams as needed to maintain a positive relationship with clients.
• Act as a point of escalation as needed.
• Provide financial oversight for the Biostatistics and Programming department.
• Develop and oversee departmental staff (activities to include interviewing, terminations, promotions, training, personnel growth and retention plans, performance appraisals, goal setting, and salary adjustments).
• Supervise and mentor reporting staff in tasks and activities to develop the team structure and enhance departmental and project performance.

Vice President, Biostatistics & Programming

• Set strategy, develop, lead, and oversee global data management department.
• Develop and track metrics on productivity and quality, and create strategies and best practices.
• Hire, supervise, and mentor data management leaders to effectively manage projects and staff.
• Develop and maintain Standard Operating Procedures and other departmental processes and procedures in accordance with guidelines and regulations to ensure quality deliverables.
• Provide strategic input to business development activities, such as capabilities/bid defense presentations and Requests for Proposals (RFP’s).
• Provide strategic input to technology for current and future state.
• Develop study-specific bids that demonstrate an understanding of each client’s needs in a creative, innovative, efficient, and effective manner.
• Oversee operational execution of data management activities within the scope of the contract.
• Maintain an awareness of project issues and support teams as needed to maintain a positive relationship with clients.
• Act as a point of escalation as needed.
• Provide financial oversight for the Data Management department.
• Develop and track metrics on productivity and quality, and create strategies and best practices.
• Develop and oversee departmental staff (activities to include interviewing, terminations, promotions, training, personnel growth and retention plans, performance appraisals, goal setting, and salary adjustments).
• Supervise and mentor reporting staff in tasks and activities to develop the team structure and enhance departmental and project performance.
• Represent the department and company in a multi-disciplinary setting, including project team meetings, client meetings/presentations, bid defense meetings, and be on the podium at industry events.
• Review and approve non-billable travel requests for the data management team and maintain department utilization.
• Act as a data champion within the company.

Senior Clinical Data Manager

Vice President, Biostatistics & Programming

Vice President – Data Management