Daniel Drew Email and Phone Number

• Leads and manages the start-up and clinical teams• Plans and leads execution of the day to day activities for the monitoring of a clinical study and communicates consistently with the clinical team providing project objectives, expectations and status updates.• Monitors the quality of clinical deliverables and addresses quality issues with the appropriate team member• primary liaison for clinical monitoring issues, interacting with clients, vendors and other functional areas, escalating as required• Interfaces with other Functional Leads, vendors and client as required to ensure clinical monitoring outcomes are achieved• Reviews filing of Essential Documents in the electronic Trial Master File to ensure sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH guidelines• Contributes to Business Development activities participating in proposals and bid defenses as needed

• Contribute to evidence generation plans • Design and execute various study solutions that fill evidence generation gaps • Support the execution of advisory boards related to evidence generation and studies 
Write study protocols • Lead the execution of high quality and timely studies - from start-up to completion - in adherence to all regulatory requirements, Roche internal procedures, good clinical practice and MSA strategy • Accountable for the development of study project timelines and tracking to plan • Accountable for accurate study budget forecasting and spend management • Liaises with investigators as required to discuss study processes, budgets, and status • Provides timely and regular updates to internal and external stakeholders on study status • Accountable for all documentation and reports needed for regulatory agencies and internal roche systems • Coordinates activities of various study team members (internal MSA and external) and keeps all relevant parties updated on relevant study activities and/or changes • Provides applicable training and oversight to external vendors including CROs, consultants and/or medical advisors • Conduct adverse event reporting and safety responsibilities and monitoring as applicable with local regulations • Responsible for timely contract processing and assay/reagent ordering • Supports strategic site selection for local and global studies, in collaboration with 
local and global MSA/CDMA colleagues. • Continuous evaluation and improvement of study management operational processes, systems, and tools to ensure delivery of studies with efficiency and excellence • May support transfer of study results into scientific publications, abstracts, presentations as needed, in collaboration with other internal and external stakeholders • Acts as a coach and mentor for colleagues and peers to develop skills, expertise • Supports the creation of an inspiring team environment with agile, open, and inclusive culture

• Manage, coordinate, and support clinical monitoring activities for 150 international clinical research centers• Collect regulatory documentation and ensure accuracy• Review source documentation and data entry to ensure accuracy• Independently complete all monitoring visits according to the trial monitoring plan• Update, and modify trial operating procedures related to data quality and monitoring• Assisted in cultivating a data quality committee and served as assistant to the data quality chair• Provide leadership, management, and direction and responsible for the operation of the program within the designated Research Center or Program• Work collaboratively with federal and industry agencies for items related to the Research Center or Program. • Participates in grant renewal processes and progress reports. Initiates and maintains positive working relationships with internal (e.g. IRB, Compliance Office, MCA, MCF, etc.) and external customers (e.g. FDA, NIH, OHRP, etc.). • Manage projects and serves as a primary resource for issues and communications relating to the Research Center or Program.Major accomplishment: Independently monitored 123 international centers

• Coordinate clinical trials across phases 2 to 4.• Team leader for prescreening, enrollment and data collection.• Interact with Investigators to ensure oversight of all study-related activities and enrolled study subjects.• Maintain and update the CTMS (Clinical Trial Management System) to ensure complete and accurate information

• Managed all aspects of Regulatory process for industry-sponsored clinical trials.• Coordinated initiation of new research projects.

• Managed clinical trials from inception to closeout.• Liaison between investigators and other research team members for regulatory compliance.