Peachtree BioResearch Solutions

Business Development Rep

• Utilize market intelligence and technologies to identify and develop contacts
• Penetrate new accounts - Inside sales will help, but BD Directors should also be setting new meetings
• Meet specified targets including quarterly and yearly sales goals
• Prepare, maintain, and update sales and marketing plans for your territory - track in CRM
• Participate in proposal development to ensure the proposal speaks to key decision makers and drivers for project award
• Manage as well as drive internal teams throughout sales process
• Stay current on news, trends, and other topics that impact sponsor prospects / clients
• Participate in conferences, trade shows, and other industry events

Business Development Director

QA Engineer

• Initiates and executes internal, site and vendor audits and assessments to assess quality standards, and creates Annual Audit Program
• Provides QA advice on complex procedures to Clinical staff
• Performs quality review of QMS documents
• Responsible for testing and assessing the quality objectives
• Identifies need for project-specific QAMPs, creates, maintains and executes QAMPs and coordinates updates of QAMPs
• Mentor for new QA staff
• Identifies improvement possibilities for continuous development of Julius clinical and initiates and executes project teams working on improvements to processes
• Initiates and executes implementation of new regulations within company
• Collects and interprets data on quality of study conduct and identifies points that require improvement on the basis of the data; Initiates and creates annual department reports
• Is responsible for the application of new quality technologies and methods
• Coordinates and hosts sponsor audits and regulatory inspections
• Coordinates and maintains the CAPA Program
• Assists Global Director Quality Management

QA Manager

Clinical Operations

• Managing, supporting, and mentoring CRAs, including but not limited to continued oversight of CRA performance metrics including monitor visit scheduling/conduct, visit reporting, accurate time sheet entry, and compliance with Peachtree travel policy.
• Partnering with Business Development/Sales to present in various business development/sales meetings, representing Peachtree monitoring resourcing and strategy, and support with proposal and budget development from monitoring perspective.
• Assist in the development and implementation of strategy for Clinical Operations and O&C as it relates to contracts, vendor selection, and vendor management.
• Responsible for reviewing and interpreting available department and project finance dashboard data as oversight of CRA resourcing and compliance with study specific site management and monitoring budgets, in support of project teams.
• Work with Clinical Operations leadership and Finance to develop and implement budgets that will maximize profitability.
• Overseeing and partaking, if needed, in the selection of sites through the Qualification and Site Eligibility processes.
• Providing support to the Project Team and assuming additional roles as needed
• Attending pre-study visits, initiation visits, interim monitoring visits, and closeout visit as Contract allows.
• Perform CRA Oversight visits to evaluate CRA performance, as needed.
• Working with Project Manager to review all monitoring reports and follow-up letters in a timely manner and ensuring that the CRAs are submitting their monitoring reports and follow-up letters per the study/Peachtree guidelines.
• Attending study team teleconferences/meetings as needed.
• Attending Investigator meetings and providing support as needed.
• Conducting Monitor Assessment visits as needed.

Manager, Clinical Operations

Data Scientist

• Responsible for all data management activities associated with the acquisition, documentation, review, cleaning and processing of clinical data in clinical trials
• Relay information regarding data management status, knowledge regarding area of discipline, and timelines affecting Data Management deliverables as a member of the clinical study team
• Ensure the Case Report Form is designed according to the Clinical Protocol, utilizing Data Standards where possible, and document deviations if necessary
• Create the Data Management Plan, Data Cleaning Plan, Quality Control Plan, and Data Management Report ensuring consistency with the Clinical Trial Protocol and compliance with internal or sponsor procedures, regulations and Good Clinical Practices
• Project, plan, develop, implement and deliver quality results in a timely manner using facts, data, measurements and a systematic approach
• Interpret the Clinical Protocol to ensure the accurate and efficient design of the CRF
• Analyze metrics surrounding activities associated with acquisition, documentation, review, cleaning and processing of clinical data
• Interpret study timelines and prioritize workload appropriately
• Assist with Clinical Data Associate activities during times of peak workload

Business Development Director

QA Manager

Manager, Clinical Operations

Clinical Data Manager