Highly effective Senior Study Mananger offering over 20 years of leadership experience in the clincial research industry. Energetic and results-focused with success in developing and leading diverse teams to achieve outstanding results.
Lead Clinical Trial Team in key study planning, development and execution elements ensuring compliance to both GCP and ICH-GCP guidelines.
Ensure data managemend deliverables are met.
Accountable for ensuring protocol level plans.
Work closely with country affiliates to ensure country/site selection are completed and meet the needs of the recruitment deliverable.
Organize and provide Investigator Meeting and supplemental training to the Investigator Sites, Clinical Research Associates and clinical team members as needed.
Lead team for timeline management, risk identification, mitigation and issue resolution.
Operational oversight and managment study specific partners and vendors.
Particpate in the development or recruitment strategies to ensure milestones are met.
Implemented a tracking and follow-up tool to increase recruitment and ensure compliance with the recruitment plan.
Managment of Global affiliates to ensure alignment with protcol expectations and deliverables.
Lead and managed the global multidisciplinary clinical trial team responsible for planning, conducting and report on clinical trials in Ophthalmology surgical device therapeutic area.
Contributed medical/scientific/feasibility input for the development of the protocol synopsis with collarboration with country medical advisors.
Independently ensured quality and timely execution the clinical trial within timeline and budget.
Forecasted trial budget resource needs and accountable for the development, management and tracking of the budget throughout the clinical trial.
Wrote scientifically rigorous protocol with coordination of medical expert input and ensured timely finalization of document.
Responsible for authoring study-specific documents including, manual or procedures, informed consents, and site monitoring plans, and providing review and input in Investigator Brochure, Statistical Analysis Plan, and Data Validation Plan.
Closely worked with Clinical Trial to team complete feasiblity and selection of countries and sites.
Ensured Investigational Product supply was obtained and in compliance with country-specific requirements.
Defined clinical outsourcing specifications for clinical trial to identify vendors, and define scope of work and contract requirements.
Tracked trial progreass and milestones. Resolved issues within the team and appropriately escalated issues as needed.
Ensured ongoing data quality review, data cleaning, protocol deviation review and database lock. Escalated issues and trends as appropriate.
Lead Clinical Trial Team meetings and ensure timely communication of meeting agenda and minutes.
Contributed to the development of clinical sections of regulatory documents, including Investigator's Brochures, briefing packets, safety updated, IND/NDA submission documents, responstes to Health Authority questions.
Responsible for implementation of best practices and standards for trial management including sharing lessons learned.
Developed training material materials, slide presentations, guidance documetns and worksheets to train Investigators, Coordinators and Monitors for Investigator Meeting and and any other training needs.
Additional Initiatives above Senior Study Study Manager role:
Developed test scripts and completed system testing
Developed training plans and training materials
Provided onboarding training to new colleagues
Providing updates on systems enhancements
Addressed questions/issues and escalated as appropriate
IRT Governance Commmittee
Investigator Meeting Task force
Responsible for dleivering the operational apsects on several multi-contry clinical studies from protocol feasibility through database release and also supported effective study reporting and close-out; submission activities; and audits/inspections.
Coordinated the activities and deliverables fo all study conduct partners to ensure timely delivery of quality data.
Ensure that the protocol and Monitoring Plan were consistently and appropriately implemented across investigor sites and countries.
Proactively identified and reoslved study operations-related issues as needed.
Ensured that the operational aspectis of a clinical study were meeting, quality and cost targets consistent with the Clinical Development Plan.
Ensured that the studies were conducted in compliance with GCP, relevant SOPs and regulatory requirements.
Assisted with the devlopment of project plans and implementing resourece strategies to achieve team's project goals, including contingency planning and risk mitigation strategies.
Supported efficients implementatin and utilization of globally agreed, processes, technologies and strategies.
Reviewed and approved trial budget, including per subject and ancillary investigator costs.
Reviewed and approved databae design, agreement on data quality requirements to ensure completin within project deliverable timelines.
Developed and implemented study level recruitment/retention strategy/plan.
Ensured timely completion of site selection and site readiness.
Ensure appropriate functions received training on the protocol.
Organized and implemented Investigator Meetings and delivered presentations.
Ensure trial drug supplies were labeled and supplied in a timely manner.
Supported study team with vendor and CRO selection and management.
Analyzed data query trands and provided feedffedback as appropriate.
Communicated data timelines and monitored against the progress for database locks.
Collected, conolidated and reviewed protocol deviations with Clinical input.
Ensured all study close-out activities were completed within timelines.
Suported study in developing submissions and addressing reporting and regulatory queries as needed.
Additonal Accomplishments above Study Manager Role:
Selelcted as Subject Matter Expert for the Study Manager Role to pariticipate in the Informed Conset Team (FDA Commitment).
Developed a Task Ownership Matrix (TOM) for Study Manager transitions that were roled out company-wide.
Recognition Award by Trial team for exceptional performance above required responsibilites.
Recipient of several awards for achieving milestones.
Presented at National Meetings: Study Manager Recruitment Challenges and Guidance.
Selected a Subject Matter Expert:
Provided support and leadership to the Site Monitors on mulitiple clinical trials.
Conducted training teleconferences and supported training needs throughout all phases of the trial.
Planned and presented at Study Coordinator Trainings as a support to the Clinical Trial Team.
Ongoing review of monitoring visit reports with issue review, resolution and escalation as appropriate.
Developed training tools and guidance documents to support monitoring activities.
Developed and updated Case Report Form Completion Guidelines as needed.
Developed Site Monitoring Plans and updates as needed.
Timely distribution of communications to study team with follow-up as appropriate.
Mentor and Trainer to Monitors on the following:
Technical Trainer Role:
Committe and Initiative Involvement:
Companies Worked For:
Job Titles Held: