Resume

Director of Clinical operations

Location:

Miami, FL

Salary:

150000

Posted:

June 17, 2020

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Resume:

Last Updated: **-JUN-****

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Saul Alvarez Gomez

USA-Miami-1951 NW 7th Avenue

Manager, Clinical Operations

Biography

Saul Alvarez Gomez has 3 year(s) of experience with Syneos Health as a Clinical Operation Manager. Additionally, Saul Alvarez Gomez has 13 year(s) of experience in the Contract Research Organization (CRO) Industry.. Furthermore, These experiences have culminated in Saul Alvarez Gomez being an integral part of the Biopharmaceutical Acceleration Model (BAM), which is shortening the distance from lab to life. Professional Experience

Jan 2019 - Present Miami Florida USA

Manager Clinical Operations

The manager, clinical operations is responsible for managing employees and the clinical operations to ensure that our clinical studies are meeting: quality standards, expected timelines and costs, and ensure volunteer safety.

Plan, organize, manage and monitor the sector's activities according to their field of expertise, the work plan, and the needs of the division and the organization in order to achieve the expected results.

Ensure that high-quality customer service is offered by employees.

Ensure that the needs in human resources, equipment, supplies and facilities meet operational needs according to established standards.

Ensure that employees have received the required training in order to adhere to existing regulations.

Ensure that regulatory requirements are adhered to.

Is responsible for volunteer safety, health and comfort.

Develop and improve the working tools, standard operating procedures and processes to facilitate the operations of sector's activities.

Manage human capital including workforce planning and hiring activities, performance management, facilitate knowledge development, and ensure the efficiency and mobilization of the team in order to achieve the expected results.

Help to develop, analyze, improve and disseminate the operational indicators.

Identify opportunities for improvement in order to amend the division master plan and processes.

Contribute to the development of the sector's budget, ensure that it is being adhered to, perform budget follow-up for pertinent stakeholders and recommend actions in an effort to achieve the expected results.

Last Updated: 17-JUN-2020

Represent their sector, both internally and externally, as a source for consultation and/or information and/or reference.

May be assigned other clinical tasks.

Apr 2018 - Jan 2019 Miami / California / USA

Director of Operations

Responsible and accountable for the conduct of clinical trials. Oversee all operations, manages timeline and deliverable of our Pharma clients (Pfizer, GSK, Novartis, Pharm Olam international and Teva). Oversee, lead, and manage cross-functional team resources and external service providers (including clinical operations, medical monitoring, safety, data management, auditors, Clinical study managers and consultants) to conduct trials on time, on a budget, in compliance, and of the highest quality. Develop Monitoring plan and action plan for the clinical study manager team. Coordination/execution of all operational aspects of clinical studies (including identification and management of vendors, availability of clinical supplies at the sites, review, and approval of a request for investigational test articles). Work collaboratively with cross- functional internal and external teams including regulatory affairs, medical writing, and biostatistics. Identify, qualify, audit, and manage all external vendors, including CROs. Take initiative to continually monitor each external vendor in performance management, escalate issues where appropriate, and make the appropriate changes in order to ensure trial conduct is completed in compliance and meets the company's business objectives. Ensure clinical trial team and clinical trial sites are properly trained and in compliance with company and/or CRO SOPs, CFR/EMA regulations, ICH GCP guidance, and study protocol. Identify any gaps in company/CRO SOPs and develop internal SOPs as needed. Identify, qualify, manage, and maintain relations with clinical trial sites, including collaborating with Principal Investigators and field team on developing robust study protocols, drive site selection, and patient recruitment programs that deliver enrollment targets. Performs site monitoring with field team, as needed. Facilitates all start-up activities including but not limited to investigational site contracts, investigational site, and ethics committee submissions. Facilitate confidentiality agreements, negotiate study agreements and budgets with sites and external vendors. Responsible for writing, reviewing, and/or approving clinical project deliverables such as scope definition documents, investigational product labeling/kitting, Pharmacy Manuals, informed consent, IRB submissions/approvals, site activations, monitoring plan and tools, CRFs, DMP, edit checks, safety plan, DMC charter, close-out plans, and CSRs. Assist with the development of presentations, handouts, and coordination of Investigator Meetings. Drive site selection and patient recruitment programs that deliver enrollment targets. Responsible for ensuring the trial is

"audit ready" at all times. Work with appropriate team members to ensure that all TMF-related documentation is current, on-file at respective site, CRO, and sponsor locations throughout trial conduct. Notify and prepare the team for regulatory agency audit and address any audit observations appropriately and in a timely manner. Performs oversight of trial to ensure that safety concerns and/or adverse events/SAEs are properly tracked and reported. Provides regular updates to the management team, vendors and contract staff concerning status and Last Updated: 17-JUN-2020

progress of the trial. Manages each project within agreed upon timelines. Proactively monitors and reports trial progress and performance, timelines, and financial metrics on an ongoing basis to the management team, including the current status of study milestones and forecast budgetary requirements based on the scope of work. Oct 2017 - Jan 2019 Homestead, FL, USA

Site Director

Execute deliverables of all aspects of assigned clinical studies including but not limited to: investigator selection, study startup, authoring/preparation of study-related documentation (e.g., protocols, case report forms, consent documents, laboratory and study procedures manuals, etc.), study conduct and close out activities. Manager Pharma Portfolio of clients (Pfizer, GSK, Novartis, Pharm Olam international and Teva). Participate in preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team. Independently manage Clinical Research Organization and other vendors, including contracts, budgets and invoicing. Provide regular updates on study progression to Director, Clinical Operations West coast, and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues. Identify barriers to timely and successful study execution and propose solutions to same. Provides monitoring oversight by reviewing monitoring schedules, metrics, and reports. May oversee or manage clinical documentation and reports. Works on study feasibility assessments and selection of countries and sites for study conduct. Assure compliance with all regulatory requirements for monitoring compliance with all company standard operating procedures (SOPs), GCP, FDA and applicable international regulations concerning clinical activities. Drive data collection, clinical trial database construction, and assist with necessary audits of data to ensure data integrity. Mar 2017 - Aug 2017 Miami, QC, Florida

Manager, Clinical Operations, ES Clinical Operations inVentiv Health Clinical Research Services, LLC

Miami, QC, Canada

Ensure that high-quality customer service is offered by employees.

Ensure that the needs in human resources, equipment, supplies and facilities meet operational needs according to established standards.

Ensure that employees have received the required training in order to adhere to existing regulations.

Ensure that regulatory requirements are adhered to. Last Updated: 17-JUN-2020

Is responsible for volunteer safety, health and comfort.

Develop and improve the working tools, standard operating procedures and processes to facilitate the operations of sector's activities.

Help to develop, analyze, improve and disseminate the operational indicators.

Identify opportunities for improvement in order to amend the division master plan and processes.

Represent their sector, both internally and externally, as a source for consultation and/or information and/or reference.

May be assigned other clinical tasks.

Aug 2016 - Mar 2017 Miami, QC, Canada

Feasibility Project Manager, ES Clinical Operations The position is responsible for leading assigned feasibility projects to support site identification and selection decisions.

Create ideal site characteristics and site selection criteria based on protocol attributes and translate them into informatics queries and feasibility questionnaires to be used for identifying and selecting high enrolment potential sites.

Query relevant databases, including clinical trial registry tools, epidemiology resources, and internal sources, and research various literature sources to support preparation of robust feasibility, site identification and selection deliverables.

Make written and oral contributions to proposals and bid defence meetings as needed.

Author protocol-specific feasibility questionnaires, compile responses, and produce tables and listings.

Collaborate with study physician and feasibility leadership to analyse, interpret data, prepare robust feasibility reports.

Develop expertise in enrolment modelling and predictive analytics.

Track and document status of feasibility projects and prepare tracking tabulations.

Manage feasibility services folder, organize electronic files.

Monitor opening of project codes for feasibility studies.

Compile investigator list for feasibility study from Investigator DB and professional organizations.

Modify feasibility data collection spread sheet template for individual feasibility studies.

Compile and analyse feasibility data collected from the team conducting feasibility study in various countries.

Last Updated: 17-JUN-2020

Jan 2016 - Nov 2016 Hialeah, FL, USA

Chief Executive Officer

Leads the development of the company's strategy. Oversees the implementation of company's short term and long term plan; develop a relationship with outside organizations, including medical community, referring physicians and media. Safeguard required compliance with state federal CMS regulations as well as hospital policies. Ensure that the company is organized and staffed: ensure compliance and implement clinical procedures and policies; encourage all employees to conduct their activities in accordance with all applicable law and health policies; ensures that the company expediters are within the annual company budget; establish best quality patient care standards and delivery excellence. Nov 2015 - Jan 2016 Miami, FL, USA

Chief Operating Officer (COO)

Participates in development of long-range strategic plans, governance structure and objectives for practice management. Participates in recruitment and retention of professional and nonprofessional staff. Participates in establishment and implementation of organizational policies and procedures. Interprets policies, objectives and operational procedures. Participates in the development and implementation of the mission, vision and values of the Center, including the deliverance of high quality, patient focused health care. Resolves problems related to staffing, utilization of facilities, equipment and supplies for the Center. Evaluates performance and recommends merit increases, promotion, and disciplinary actions. Analyzes and recommends changes in organizational systems, policies and procedures and ensures their implementation. Delegate authority and responsibility as appropriate. Participates in professional development activities to keep current with trends and practices in health care administration (conferences, journals). Participates in the evolution and refinement of the quality improvement process at the Center. Undertakes special projects as directed by the President/CEO. Although each position has its own unique duties and responsibilities, please refer to the policy on Job Descriptions for details that apply to every position.

Apr 2014 - Nov 2015 Senior Site Director

Miami, FL, USA

Ability to collect and analyze all information. Ability to manage multiple projects and prioritize work. Ability to prepare research designs. Immense Microsoft Application skills. Proficient in psychiatric therapies. Familiarity to resolve all research issues. Solid understanding of research protocol. Manage and overseeing 3 clinical research site within the institution. Assuring quality of data and subject safety. Project manager and timelines setups. Hiring new and temporal personal. Providing and maintaining required trainings according to local and standards guidelines. Ensuring a hazard free work environment for all staff. Scheduling monitoring and Sponsors Site visits. Provided solutions to complex logistic problems. Prepared study design and implemented all protocols. Ensued compliance to Quality system and international standards. Coordinated with various teams and designed clinical research projects. Provided Last Updated: 17-JUN-2020

technical support to all clinical personnel and employees. Startup operation supervision. Regulatory operations. Staff Schedule, management and production. Develop CAPA after audits and educational programs after any audit finding or notation. Prepared efficient schedule for training plans for the internal teams. Created various project team meetings to evaluated and maintained study files. Maintained trial management tools and provided update to sponsors. Monitored clinical visits and assisted in follow up. Participated in all project management teleconferences on weekly basis. Developed study associated monitoring tools for research project. Performed regular agency audit on all clinical sites. Evaluated study tools and prepared source documents worksheets. Maintained confidentiality of information and ensure compliance to strict code.

Feb 2013 - Apr 2014 Miami, FL, USA

Site Director

Prepared study design and implemented all protocols. Ensued compliance to Quality system and international standards. Coordinated with various teams and designed clinical research projects. Provided technical support to all clinical personnel and employees. Developed budgets Contract with second parties. CTA finalization negotiations, review and Finalization. Startup operation supervision. Regulatory operations. Internal budget management and timelines. Staff Schedule, management and production. Develop CAPA after audits and educational programs after any audit finding or notation. Develop marketing strategies. Assisted clinical investigators to perform clinical research on areas of specialty. Analyzed study objectives and prepared appropriate strategies Performed regular review for all projects and achieved objectives. Coordinated with work groups and ensure compliance to timeframe. Prepared efficient schedule for training plans for the internal teams. Created various project team meetings to evaluated and maintained study files. Maintained trial management tools and provided update to sponsors. Monitored clinical visits and assisted in follow up. Participated in all project management teleconferences on weekly basis. Developed study associated monitoring tools for research project. Performed regular agency audit on all clinical sites. Evaluated study tools and prepared source documents worksheets. Maintained confidentiality of information and ensure compliance to strict code.

Jun 2012 - Feb 2013 Miami, FL, USA

Senior Clinical Coordinator/CRC/LPN

Primary liaison between Clinical Operations and Safety Operations for management of Phase 1 to 4 trials. Safety representative in product meetings, study team meetings and document reviews, such as Investigator Brochures, IND Annual Reports, Study Protocols and Amendments, Case Report Forms, Clinical Study Reports, Informed Consents and Data. Created, developed, maintained departmental SharePoint website, increasing communication and providing a centralized location for resources and information. Developed and maintained departmental workload tracking system for accurate metrics reporting and resource allocation Collaborated with multi-functional teams to produce and communicate critical safety information Last Updated: 17-JUN-2020

to clinical sites and regulatory agencies within given timelines. Systematically composed and managed language for Risks and Discomforts sections of Informed Consents across multiple products, providing standard template across all studies. Directly managed up to 40 staff members, including three in remote locations, whose primary roles were to support and manage study start-up activities for Early Development (phase I) and General Medicine trials. Conducted effective bi-weekly one-on-one meetings, mid-year and annual reviews with each staff member, with greater than 90% retention of staff. Partnered with global counterparts for process alignment related to training, study supplies ordering and feasibility. Liaised between management team and metrics team to develop resource model for tracking workload capacity and resource allocation. Integral project team member in improving process for distribution of IND Safety Reports to clinical sites. Collaborated with project team to developed streamline procedures for processing Confidentiality Disclosure Agreements. Nov 2010 - Nov 2012 Miami, FL, USA

CRC Certified Clinical Research Coordinator

Maintain protocol requirements for patient visits, patient visit schedules, blood draw, test procedures, and drug accountability requirements. Complete all study documentation forms like case report forms and other specific research documents. Conduct patient care visits and assure that all procedures are performed in compliance with the standard of the hospital. Interact with investigators to assure that the patient receives appropriate medical evaluation and care, when needed. Interact with clinical research associate to facilitate monitoring and database clean-up process. Attend meetings and conduct clinical research in compliance with all the applicable regulations.

Aug 2006 - Nov 2010 Miami, FL, USA

Clinical Supervisor

Assign tasks of developing and preparing clinical research protocols. Responsible for organizing all aspects of medical research project of the organization. Coordinate the functions of different departments who work for clinical trial in investigating new health care terminologies, medicines, and procedures. Handle the responsibilities of managing investigation devices and maintaining database of the project. Perform clinical trial preparation like planning, assembling and instructing clinical trial team. Ensure that the medical professional that participates in the clinical research is qualified to fulfill the assigned duties. Handle responsibilities of conducting clinical trials and clinical research staff.

Languages

English - Speaking, Reading, Writing

Last Updated: 17-JUN-2020

Spanish - Speaking, Reading, Writing

- Native

Professional Certifications & Licensures

RN9498058

- Oct-2018

Education

2020 American Sentinel University - United States

Bachelor - Nursing

2013 Dade Medical College - United States

Associate - Nursing

2011 Dade Medical College - United States

Diploma - Nursing

Publications & Presentations

- Gomez, S.A., Suarez, L. The Key to Becoming an Exceptional Clinical Research Professional. Clinical Research / Pharma News Aug 2015.

Contact this candidate