David Tattle, M.S. Email & Phone Number

Boston, Ma, Us

Boston, Ma, Us

Boston, Ma, Us

-Monitor drug and ancillary supplies and place orders with the central depot to ensure adequate stock at sites-Consolidate dosing data from electronic source to ensure patient dosing compliance-Monitor clinical trial Insurance and license agreements across studies and work with vendors to ensure current agreements-Manage internal process for approval of contracts, purchase orders and invoices-Facilitate shipment of various samples defined in the protocols to third party labs-Manage Clinicaltrials.gov postings-Manage translations of study documents-Develop and maintain internal and external trackers-Assist in the development of study documents, including study and lab manuals

Boston, Ma, Us

• Serve as the main contact for Sponsors and/or CROs• Interact with internal cross-functional teams to develop trial database(s), procedures, and training programs to support assigned clinical trials, including creation of study specific documents• Ability to anticipate issues and prepare contingency plans with oversight, including change orders• Ensure all procedures for trial conform to the proper regulatory standards• Produce reports and presentations as required, including study timelines• Perform monthly billing and approval of project invoices• Manage escalation of issues, suggests solutions and mitigations, and communicates findings • Training and management of Clinical Operations Associate(s) and independent reviewers; ensure their tasks are completed within the agreed timeline

Boston, Ma, Us

• Work under direct supervision to ensure consistent performance • Upon completion of training the employee must demonstrate the ability to workindependently • Report accurate information in a timely manner to incoming requests from Sponsors and/or CROs • In some situations, serve as the main contact for Sponsors and/or CROs• Coordinate activities required to manage and complete a project as detailed in the Sponsor contract and Study Specific Procedures. • On-going project tracking, including monitoring of project budget and finances, and provide status updates to appropriate parties • Delegate project activities to designated project staff • Engage with project teams, Sponsors or CROs in the resolution of issues • Responsible for streamlining all trial functions thus increasing productivity andaccuracy of all trial data• Identify resource requirements and communicate project needs to the Operations Lead • If working with another Project Manager, may recommend procedural or systemchanges to the Project Manager to improve the effectiveness of the trial’s operations • Demonstrate consistent and cooperative service in support of the trial sponsor,staff, co-workers, and individuals outside of the organization • Receive, track and process data from participating sites according to SSP’s • Assist the PM in training of new staff to SSPs and documentation used in thedesignated trial • Extensive record data entry • Maintain and update trial tracking databases • File, data entry, trial room set up, file storage, and any related activity to ensure the success of the Clinical Trials operations

Boston, Ma, Us

• Serves as the conduit between the customer community (internal and external customers) and the software development team through which requirements flow.• Proactively communicates and collaborates with internal and external customers to elicit functional requirements using interviews, document analysis, requirements workshops, surveys, business process descriptions, use cases, scenarios, business analysis, and task and workflow analysis.• Collaborates with developers and subject matter experts to establish the technical vision, reconcile conflicts, and analyze tradeoffs between usability and performance needs.• Decomposes high-level information into details, abstracts up from low-level information to a general understanding, and distinguishes user requests from the underlying true needs.• Designs and delivers artifacts to assist in project development, including user requirements specifications, workflow diagrams, form designs and functionality, and report layouts• Develops requirements specifications according to standard templates, using natural language.• Drives and challenges business units on their assumptions of how they will successfully execute their plans. • Possesses strong analytical and product management skills, including a thorough understanding of how to interpret customer business needs and translate them into application and operational requirements.• Displays excellent verbal and written communication skills, and the ability to interact professionally with a diverse group, executives, managers, and subject matter experts.• Adapts to new technical challenges, building off a strong existing knowledge base to complete tasks using new methods, languages, and applications as needed

Boston, Ma, Us

• Consistently performs duties within established Standard Operating Procedures,Work Instructions and Study Specific Procedures in accordance with GoodClinical Practices • Perform verification and quality control of data received from Investigator Sites,CROs, and/or Trial Sponsors • Maintain trial tracking database and project files • Perform established processing techniques across multiple imaging modalitiesusing proprietary and third-party package software • Assist in the training of Investigator Site personnel with image acquisition and/or transfer • Generate queries and follow through to ensure resolution • Report accurate information in a timely manner to incoming requests from CROsand/or Trial Sponsors• Provide mentorship and training to team members as required. • Provide oversight of clinical trial tasks to ensure timely completion.• Create User Requirement documents as needed.

Boston, Ma, Us

• Consistently performs duties within established Standard Operating Procedures, Work Instructions and Study Specific Procedures in accordance with Good Clinical Practices• Perform verification and quality control of data received from Investigator Sites, CROs, and/or Trial Sponsors • Maintain trial tracking database and project files• Perform established processing techniques across multiple imaging modalities using proprietary and third-party package software• Assist in the training of Investigator Site personnel with image acquisition and/or transfer• Generate queries and follow through to ensure resolution• Report accurate information in a timely manner to incoming requests from CROs and/or Trial Sponsors

Boston, Ma, Us

Philadelphia, Pennsylvania, Us

Accept and apply data input to prescription information, assuring applicable quality standards are maintained.Maintain an inventory of over 200 medications, ensuring perpetual stock.Ensure customers receive prompt service by assisting with purchases at cash register.

Certificate, Leadership Essentials

Master Of Science, Regulatory Affairs For Drugs, Biologics, And Medical Devices

Bachelor Of Science, Business Administration-Management