Frank Lin Email & Phone Number

Pleasanton, Ca, Us

Veeva Clinical Market Strategy- Define clinical product growth vision and support market-specific messaging- Leveraging customer relationships and interviews, market knowledge, and evolving compliance frameworks to partner with Veeva product, sales, and services teamsTechnology Adoption Partner- Educating clients on our vision and solution capabilities during software evaluations and implementations.- Supporting governance/relationship management with both customers and partners to ensure optimal outcomes.Product, Sales, and Services Bridge- Advising partner functions with a combination of R&D industry and business change experience, relationships with key client contacts - Aligning cross-functional goals, product milestones and challenges

Boston, Massachusetts, Us

Program Lead in:Technology Solutions in Life Sciences- Remote monitoring, digital health, and transforming life science operations- Technology road maps; business cases of how to reach organizational goals- System vendor selection advising, Implementation and Change ManagementClinical Research Process Consulting- Accomplishing clinical program goals with technology and tools- Assessing processes and data integrity- Developing efficient, effective future state processesCompliance Programs and Audits- Building a single compliance program and holistic approach that meets numerous global regulations- Audit preparation, building audit playbooks and mapping audit elements to objective evidence- Process improvement in documentation and QMS

Boston, Massachusetts, Us

Boston, Massachusetts, Us

Boston, Massachusetts, Us

Boston, Massachusetts, Us

Clinical Project based role with diverse functional responsibilities, including:Process Improvement- Developing revisions to SOPs and study specific plans- Working internally and with vendors to implement new software and project management systems- Analyzing study/site data to produce relevant metrics for recruitment and marketing decisionsDocument and Reporting Lead- Managing major revisions to investigator brochure, ICF and other critical study documents- Organizing and documenting review of protocol deviations and serious adverse events- Writing training presentations, treatment algorithms/guides, other site references and toolsSite Management and Recruiting Support- Managing study supplement shipping- Troubleshooting issues concerning site contracts, operational logistics, and monitoring- Assisting in safety reporting and tracking for medical monitor communications

Vendor Management- First line of contact for drug management issues, site status monitoring in IWRS, and shipping- Resolving site drug management issues, reviewing and tracking investigational drug use metrics- Reviewing interim monitoring reports and tracking site performance metricsSite Startup Specialist- Reviewing all site documentation, certifications, and required access necessary for drug release and activation- Trial master file maintenanceGlobal Study Management Support- Experienced in documentation and submissions in North America, Western/Eastern Europe- Large scale operations for a global phase III with 100+ sites

Boston, Ma, Us

Site Trial Management for Oncology Studies- Responsible for data entry and query resolution, organization and shipping of patient samples, securing samples obtained from biopsies, maintaining regulatory binders and routing necessary IRB submissions, reporting study status to monitors and sponsors, tracking necessary study supplies- Producing site specific study instructions for general infusion nurses and hospital staff Early Phase Oncology- High enrolling, intensive oncology studies averaging 4-5 active studies and 9-16 ongoing patients at any given time- Ensuring patient records contain all required information per study protocols

Boston, Ma, Us

Identifying Patients for Banking Protocol- Reviewing patient medical records to identify potential patients to approach for consent- Compiling data for metrics to tissue banking committeeTissue Bank Coordinating- Tracking all samples banked under protocol- Administrative management of tissue distribution approvals, shipmentsResearch Support- Editing research papers and grant proposals for clarity- Resolving operational issues for associated laboratories

Leverkusen, North Rhine-Westphalia, De

Data Management Internship

Master Of Liberal Arts, Management

Bachelor Of Science (B.S.), Biology, General