Maria P. Ladd Email & Phone Number

Raleigh, Nc, Us

During my time with Precision for Medicine, I expanded my leadership experience to a global team in NA, WEU and EEU, operating as the head of the Clinical Support Specialist (CSS) Management function. I provided oversight, management and career development within the CSS leadership team of two Associate Directors and eight Line Managers, with a reporting line exceeding a hundred global staff. I served as support to senior and executive leadership for utilization reporting, departmental budgeting, departmental information for upstream reporting, organizational workstreams/initiatives and served as the CSS escalation and resolution point of contact for study issues.Some key contributions:• Led a team of three legacy groups of Clinical Support Specialists (CSS) into a cohesive and integrated global team• Updated integrated team title and family of job descriptions to reflect growing body of responsibilities, developed a new role within the job family• Managed and oversaw the development of tools and processes for integration, globalization, and overall process improvement of CSS activities• Managed and oversaw the development of quarterly and monthly utilization tracking and reporting

Integrate CSS function across three legacy organizationsAssess functional processes in North America for optimization, consistency and efficiency

Morrisville, Nc

During my time at Aperio, I managed the clinical support staff and brought my maintenance and TMF expertise to the forefront by working closely with teams in closing out several paper TMF trials. I strove to grow the confidence and skill set of the clinical support staff by working with them to develop training to present to cross-functional teams. As the Clinical Study Support department head, I authored several new SOPs and revised existing SOPs, along with all associated templates, tools and work instructions. Some key contributions:• Worked with the team on the implementation of an eTMF and a CTMS, including the development of user guides and training materials • Developed a practice package for CSS staff for Essential Regulatory Document review and one for Informed Consent Form review, and all applicable tools to complete the entire cycle of those review types• Organized SOCRA examination for local office

During my time with inVentiv (which became Syneos), I worked in a variety of roles, each increasing in responsibility and contribution to the organization. I began by working directly with sites in both start-up and maintenance and moved into lead roles that culminated in a global lead. I used that experience and expertise to move into managing staff working in start-up and maintenance, working to guide their careers while supporting their successes in meeting study goals. I discovered a passion and affinity for working with processes and process improvement as I broadened my footprint in the Associate Director role, working on several departmental initiatives.Some key contributions:• Led a team to develop a unique centralized resourcing model for maintenance activities in North America• Developed and conducted training on the centralized resourcing model for maintenance, as well as entry-level CRA training on start-up. Developed site-facing staff task training such as essential document review regulatory , informed consent review and performing accurate projections to sponsors• Organized SOCRA examination for local office

I started my career at PPD in an administrative role, assisting colleagues ramping up sites for clinical research. Once I knew the ropes, I began working directly with sites in start up. I performed essential regulatory document review and informed consent review, and mentored new employees as I increased my skills in these tasks.