Rick Torrence Email & Phone Number

Douglasville, Ga, Us

Raleigh, North Carolina, Us

* Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOP’s, and regulatory requirements.* Timely study initiation, conduct, and closeout ensuring satisfaction levels are met and statuses of deliverables are communicated effectively.* Lead project team to ensure quality, timelines, and budget management, including ensuring quality of clinical monitoring and site management deliverables.* Coordinates activities and deliverables of all study conduct partners and proactively identify and manage issues.

 Perform day to day management and oversight of assigned clinical trial(s) to ensure deliverables are met in all phases of trial Lead the Clinical Trial Team, and support other development teams as a Clinical Operations representative as required. Perform and document study level Sponsor Oversight of outsourced clinical activities Communicate study-status, cost, and issues to ensure timely decision-making by senior management Initiate and manage study-level timelines, including communication to internal and external team members on deliverables Work closely with other supporting clinical operations team members, if applicable, to execute clinical studies Draft and/or oversee the drafting of site materials including training, manuals and support documentation Review clinical data to ensure timely entry and readiness for data review meetings Perform periodic review of clinical data, quality metrics and study deviations Manage trial feasibility process and oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate Review of a Trip/ IMV reports to ensure timely completion and identification of issues and follow up Ensure trial samples are ready to be sent to vendors in order to meet trial deliverables Complete and maintain internal clinical trial metrics, dashboards and other internal updates Ensure trial is conducted in accordance with Moderna and ICH/GCP standards including multiple regions in global trials Participate in testing of clinical trial systems/databases (i.e. UAT) Manage invoice and budget tracking for individual studies and provide input into budget forecasting activities.

Morrisville, Nc, Us

 Deliver assigned clinical trial(s), budgets, timelines, and resource management with a focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives. Lead and manage day-to-day execution of assigned clinical trials to ensure all trial deliverables are met according to established timelines, goals, budget, and quality standards. Manage the cross functional study management team and CRO/vendor(s) related to all aspects of clinical trial operations and continuously assess operational performance through carefully designed performance and quality indicators. Effective management of issues and risks including escalation to Director, Clinical Operations, Internal teams and senior leadership. Establish study timelines and ensure accurate tracking and reporting of study metrics. Develop and execute Study Operational and Vendor Management/Oversight plans. Lead identification, RFP/bid defense, and selection of CRO/third party vendors Develop, manage, and track clinical trial budget as well as the accuracy of trial information and provide ongoing reporting and forecasting to Finance. Manage and provide documented oversight of CRO and third-party vendors to ensure quality and adherence to ICH/GCP standards as well as established study timelines. Contribute to the development of documents including the clinical trial protocol, Investigator’s Brochures, Informed Consent Forms, Case Report forms, responses to questions from IRBs and Ethics Committees and to clinical sections of IND summary documents, CTAs for initiation of studies ex-US, and responses to questions from regulatory authorities. Develop and maintain strong relationships with Investigators, site staff, and CRO partners. Contribute to Clinical Operations/organizational initiatives to build and optimize business procedures, tools, and guidance.  Review of Trip/ IMV reports.

 Overall leadership and successful delivery of EPD clinical trials and programs to ensure they are completed within budget, schedule and contracts Proactively communicate with the sponsor and functional team during the study, ensuring all are aware of project status Organize/ lead study internal, external meetings. Provide proactive decisions and solutions concerning the project objectives. Anticipate and mitigate risks for study execution Ensure compliance with SOPs, contract terms and regulatory requirements Identification and Selection of investigator site, manage investigator sites to conduct studies appropriately and on time Oversee maintenance of central files. Plan and manage resources including CRAs and Vendors Prepare Study Plans, Monitoring Plan, PM Plan, Communication Plan, Cohort Mgt Plan and Vendor Plans Coordinate project resources that result in seamless product management or deployment within predefined project timeframes and budget Develop client-specific project implementation plans and establish complete familiarity with the implementation milestones, specific site requirements (contractual or otherwise), site environment, client expectations and enterprise industry information system strategy and integrated collection technology. As appropriate, drive technical development of projects to ensure design meets customer/market requirements and maximizes project resources Manage project timelines, identifying and resolving any issues that may arise. Ensure milestones are met in a timely manner and proactively anticipates and mitigates risk to the project. Develops and manages a project communication plan to routinely communicate the project status to team members as well as internal / external stakeholders.  Work closely with cross-functional Project Management teams and facilitate the implementation process for customers, as appropriate, for both single and multi-site facilities.

Morrisville, North Carolina, Us

 Lead clinical team including CRA staff to ensure quality, timelines and budget management. Lead and/or coordinate Data management meetings, protocol planning, country/site selection, CTMS updates, Investigator Meeting planning, communication plans, monitoring plans, and preparation of weekly trial summary, lead study closeout activities. Responsible for TMF Management Plan and quality and completeness of TMF for assigned projects. Assist in CRF design and development, writing of monitoring plans, study oversight plans and study project plans. Accountable for all functional group project deliverables for each project assigned.  Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues. Ensure studies are conducted in compliance with GCP, relevant SOP's and regulatory requirements. Coordinate audit response and implementation of CAPA to finding and Quality Events. Accountable for maintenance of study information on a variety of databases and systems. Responsible for study management components of inspection readiness for all aspects of the study conduct. Oversight for development and implementation of project plans. Plan, coordinate and present at internal and external meetings • Direct the activities of assigned Project Support staff. Prepare project management reports for clients and management. Prepare high level executive summary detailing trial progress, enrollment and risks. Implement resource strategies to achieve project goals • Developing contingency planning and risk mitigation strategies to ensure successful delivery of study goals. Participate in bid defense meetings where presented as potential project manager/director. Development and writing of Monitoring Plan and Project Plans. Review of study Trip Reports Participate in Bid defense, RFP process and Budget Negotiations. Support proposals development through review of proposal text and pricing.

Durham, North Carolina, Us

• Review and approve site visit reports; ensure tracking, follow up and resolution of site issues have been completed in a timely manner.• Participate in Bid Defense, RFP process and Budget Negotiations.• Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team• Review and approve vendor invoices in collaboration with the Accounting team to ensure investigator payments occur in a timely manner• Review and approve vendor responses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and regulatory requirements.• Ensure all project level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures• Effectively provide support to Clinical Site Manager(s) in the conduct of the trials•Oversee performance of the clinical teams, third party vendors, various functional groups and field CRAs including monitoring, to ensure compliance with study protocol and in accordance with scope of work and in accordance with corporate timelines; identify areas of concern and escalate to CMO or CRO as appropriate.• Assist with establishing and tracking clinical timelines and appropriate performance metrics.• Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team.• Investigate queries, monitor discrepancies as applicable. Manage/oversee investigational product (IP) accountability and reconciliation process.• Negotiate and manage the contracts, budgets and payments for third party vendors to accurately track spend and monitor cash flow forecast for clinical plan delivery.

* Managed overall daily laboratory operations, supervise testing of samples and plasma operations activities. * Conduct quality investigations, review daily testing reports and follow up to problem management activities. * Develop and implement local QA policies and procedures to ensure conformity to specifications as mandated by the regulatory industry.* Organized and monitored small to moderately sized clinical trial for Infectious Disease, HCV, HIV, HBV.* Provided exemplary training to small group of personnel to review regulatory documents, such as consent forms, site contracts, and patient information sheets* Manage laboratory staff, complete performance reviews and coordinate task schedules.* Prepare and maintain budget with specified allowance. Evaluate precision and accuracy of testing equipment and analyze statistical data for tracking and monitoring test failure rates.* Monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports.* Managed development of Study plans, i.e.Monitoring Plan/DMP/ SAP managed process associated with safety reporting.* Vendor and site management * Ensured clinical trials were conducted in accordance with State and Federal regulations, Good Clinical Practice regulations, and internal Standard Operating Procedures

Master Of Business Administration (Mba), Health/Health Care Administration/Management

Bachelor Of Business Administration (B.B.A.), Business Administration, Management And Operations

Associate'S Degree, Clinical Laboratory Science/Medical Technology/Technologist