Donna Marie McCabe

· Manages a team of 6-10 people.

· Ensures all work is carried out in strict accordance with the relevant protocols, Standard Operating Procedures, and in compliance with Good Clinical Practices.

· Performs supervisory duties including interviewing, hiring, training, intervention, discipline, and discharging of staff.

· Coaches and mentors staff including initiating and implementing appropriate staff development programs. Meets with staff on a routine basis to review goals and individual development plans.

· Motivates team to complete high quality work efficiently.

· Schedules team workflow and allocates work to staff to meet deadlines.

· Serves as Portfolio Lead for multiple sponsors.

· Ensures that the highest levels of client service are maintained.

· Overall responsibility for assuring timeliness and quality of work for studies for entire team.

· Ensures that staff levels are adequate in quality and quantity to meet the forecasted workload. Recommends changes if necessary and justifies them in accordance with company policy.

· Ensures that appropriate training programs are in place so that staff is adequately and properly trained for their job requirements.

· Ensures that all training files are up to date and complete in accordance with SOPs and ICH/GCP.

· Organizes, chairs, and records minutes for all meetings or delegates these responsibilities appropriately.

· Updates internal timelines for allocated projects in a timely manner and renegotiates timelines as appropriate. Provides senior management with updates on timelines and projects.

· Leads the review and amendment of departmental processes and supporting documentation.

· Ensures all appropriate documentation and procedures are performed upon project completion.

· Keeps senior management and/or client services informed of pertinent project or client related information (i.e., work scope changes).

· Collaborate with respective project sponsor and stakeholders to develop effective project plans to include scope, goals, deliverables, required resources, risks, issues and milestone timing.

· Effectively plan and execute multiple Data Management projects simultaneously. Provide updates directly to senior stakeholders as requested by line management.

· Participate in Business Development presentations and bid development.

· Support the production of bids and proposals development.

· Assign tasks and responsibilities within Data Management to team members, in a manner that: optimizes team capability; delivers timely and accurate results; and supports the needs of the business.

· Ensure that assigned team executes Data Management functions in accordance with Chiltern and/or sponsor Standard Operating Procedures (SOPs).

· Provide guidance to less-experienced Project Data Managers.

· Assess ongoing and future project resource needs on an ongoing basis with feedback to Line Management.

· Clearly communicate expectations to team members and stakeholders.

· Resolve any issues and solve problems throughout project lifecycle.

· Manage sponsor relationships and triage issues as appropriate.

· Ensure that project team member performance supports project budget and delivery requirements.

· Effectively manage project scope by ensuring any changes to scope are documented and approved through appropriate change management processes.

· Effectively lead a team of cross-functional associates towards common project goals. Proactively identify and address team cohesion obstacles to project success.

· Participate in and/or contribute to Sponsor and/or Regulatory audits/inspections.

· Participate/attend Sponsor requested meetings as required.

· Perform other duties as required by the Department.

· Project Leader on a project for Data Management, to include primary customer contact for all contracted Data Management and direct liaison with Finance and Contract department on required matters (e.g., invoicing, contract changes).

· Manage change of scope, budget, revenue recognition, and participation in monthly internal project reviews.

· Monitor and communicate project progress to the customer and project team including use of project status reports and tracking tools/metrics. Ensure timelines are communicated.

· Plan, manage, and request resource for assigned studies.

· Develop and maintain the Data Management Plan, Communication Plan, eCRF Guidelines, Quality Plan; and other plans as delegated/required.

· Maintain documentation on an ongoing basis and ensures that all filing is up to date and audit ready.

· Provide project specific training for CRA and site staff (to use EDC system), project team in project specific requirements.

· Review and approve project plan and guideline for data validation, electronic data interchange, coding, CRF/eCRF screen, database design, user testing, CRF tracking, CRF/eCRF completion and other applicable project plans as delegated/required; specifications for listings and summaries (other than for statistical reporting requirements) from CRF databases, and external data sources; output from listings and summaries (other than for statistical reporting requirements) from CRF databases, and external data sources.

· Participant in, and present at internal, customer, third-party, and investigator meetings.

· Plans for and create necessary documentation to support internal and external audits; participates in such audits.

· Participate in the development of departmental technologies, SOPs, processes, and procedures.

· Lead All activities for complex global clinical trials.

· Coordinate the work of global staff assigned to the project.

· Provide training on procedures and systems.

· Create project-related materials.

· Track project progress and issue status reports.

· Develop and maintain communication with colleagues in other departments.

· Ensure the achievement of key milestones relating to the function, such as completion of tasks towards final database.

· Attend sponsor related meetings.

· Participate in business development meetings.

· Service as the principal function specialist for the department for assigned projects.

· Assist in the creation and documentation of new or revised departmental procedures and guidelines.

· May participate in or lead process improvement initiatives.

· Responsible for performing activities that follow applicable Corporate and Divisional Policies, Standard Operating Procedures and Operating guidelines and performing other duties as assigned by management.

· Provided expert skills as part of a Clinical Data Management team to provide efficient, quality data management products that meet customer needs.

· Provided leadership to the team.

· Managed DM customer relationship for DM project team.

· Provided customer negotiations on complex timeline, budgetary and other issues.

· Provided marketing capabilities presentations and business development presentations.

· Managed deliverables through full data management process life-cycle.

· Managed project timelines, quality issues, resources, and SOW (scope of work) / budget.

· Provided justification for customer negotiations.

· Served as Project Manager for single service data management projects.

· Managed comprehensive data management tasks pertaining to the Data Management Plan.

· Managed comprehensive quality control procedures.

· Provided data management expertise and data coordination process improvement to CDM management.

· Mentored other team members and Lead Data Managers in training and developing data management expertise.

· Independently brought project solutions to the CDM team and the CDM Department.

· Managed a focus team or a best practice team.

· Managed the development and implementation of new technology/tool.

· Presented at professional conferences and/or publish articles in professional journals.

· Provided Data Management with technical expertise.

· Provided review and expert opinion in developing, revising, and maintaining core operating procedures and working instructions.

· Met objectives as assigned.

· Developed and maintain good communications and working relationships with CDM team.

· Served as Lead Clinical Data Manager for one or more studies, responsible for customer contact, functional, administrative, and financial oversight for allocated projects.

· Performed the Project Management role for projects without clinical services, or act as a Clinical Data Management Franchise Lead.

· Ensured the setup activities for a study are performed correctly and in a timely manner.

· Performed study specific training and ensure all staff adheres to current procedures.

· Represented Clinical Data Management at internal and external meetings.

· Conducted presentations for internal and external clients.

· Provided mentoring to junior staff by focusing on business awareness and developmental growth.

· Provided global training to all data management staff.

· Served as Lead Clinical Data Manager for one or more studies.

· Provided support to other Lead Clinical Data Manager(s) for one or more projects.

· Liaison with clients and colleagues in other function groups as required.

· Performed all data management cleaning activities in accordance with the Data Validation Manual (DVM), and/or client documentation.

· Designated tasks appropriately within the team to ensure all work conducted were completed to the acceptable quality in accordance with global Standard Operating Procedures (SOPs) and the DVM.

· Represented Clinical Data Management at internal and external meeting.

· Performed advanced aspects of the data cleaning process, with a high degree of accuracy and in accordance with GCPs and SOPs/WPDs.

· Key responsibilities were those of an Associate I, Data Listing Reviews, and reconciliation of Serious Adverse Events and Third-Party Vendor data.