Project Management Los Angeles

EDNA TARIOUS

Los Angeles, CA • 818-***-**** • ************@*****.***

QUALIFICATIONS SUMMARY

• Results driven Business Operations and Project Management professional with experience in diverse work environments (Entertainment, Pharma, Medical Device).

• Experience in organizational diagnosis and the design and facilitation of large-scale initiatives including; change management, organizational effectiveness and organizational restructure.

• Strong facilitation skills; ability to influence and communicate effectively at all levels within the organization.

• Ability to identify and partner with key stakeholders in the organization to drive necessary change.

• Strong interpersonal skills including the ability to handle internal and external issues in a calm, positive, and professional manner.

• Refined project management skills including the ability to implement new programs and processes.

• Adept at building efficiencies, streamlining processes, and instituting best practices across cross-functional/divisional teams.

• Collaborated on cross-affiliate team to develop talent acquisition strategy and initiatives to attract and recruit talent (aligning on process, best practices, candidate experience, time management). PROFESSIONAL EXPERIENCE

Photographer, Los Angeles, CA April, 2023- Present Product Photography, Family Portraits, Image editing Parexel International, Glendale, CA

Associate Manager, Clinical Operations May, 2022-Feb, 2023 Responsibilities

• Manages and oversee clinical laboratory staffs day-to-day activities; providing direct supervision, including: hiring, training scheduling meetings, coaching, performance management/reviews, approvals of timesheets

• Identifies/modifies operational systems, training programs, tools, processes and/or materials to optimize staff develop and streamline operations in the clinic, working closely with the Senior lea- dership to implement change, promote high performance culture

• Meets regularly with feasibility team to plan for upcoming studies, including identification of stra- tegies to optimize staffing (e.g., cross training in departments, harmonization of roles/tasks).

• Provides input on protocols in development and assess timelines. Identifies risks and strategies to mitigate risk and supports leading next steps with implementation.

• Communication with the Sponsor for duration of the clinical study including site visit meetings and tour of the laboratory.

• Vendor management- Negotiates rates, contracts, and communication, approval of invoices. ET 1

• Manages all aspects of departmental performance improvement strategies including identifying areas for improvement, developing action plans in conjunction with all affected areas/staff

• Working closely with the Quality department to identify and assess quality issues within the labora- tory and putting in place corrective actions.

• Determines the necessity for the creation of departmental Clinical Operating Guidelines (COGs) and Standard Operating Procedures (SOPs) to meet hospital/facility requirements. Oversees the review, revision, and/or retirement of departmental COGs and SOPs, upon approval, oversees the training and implementation of departmental and inter-departmental COGs/SOPs.

• Maintains and updates knowledge of Good Clinical Practices (GCPs)/Good Documentation Practices (GDPs) and their proper application. Reinforces the use of GCPs/GDPs departmentally through example and staff training.

Achievements

• Revised laboratory lead checklist and responsibilities to include incubator checks, freezer tempera- ture logs, and equipment checks.

• Held weekly meetings with analytical external laboratory to ensure all test codes, results, and issues were resolved.

• Started weekly meetings with the entire laboratory and Clinical Laboratory Coordinator (CLC) to better collaboration (discussed upcoming studies, QI’s, additional trainings).

• Started “In Service” sessions with the CLCs and laboratory personnel to discuss difficult laboratory processing instructions.

• Trained all laboratory personnel on all aspects of processing and laboratory requirements regardless of employment status (e.g.; intermittent vs full-time). uniMed Pharmacy, Montrose, CA

Operations Manager May, 2020 - April, 2022

Responsibilities

• Manage the Pharmacy day to day operations including; annual budget, inventory, billing, fulfillment, marketing and compliance processes.

• Consult and coach the business on succession planning, organizational design, performance management, change management, compensation strategy, career development, talent acquisition and employee relations.

• Ensure proper handling of incident and/or accident reports through safety portals.

• Handle protected health information (PHI) in a manner consistent with the Health Insurance Portability and Accountability Act of 1996 (HIPPA). Major Achievements

• Partnered on initiatives to help support acquired pharmacy in Thousand Oaks including: business risk assessment, succession planning, business continuity and developing plans, strategies for retention and replacement of talent.

• Collaborated on a cross-affiliate team to develop the Talent Acquisition strategy and initiatives to attract and recruit talent in both locations (aligning cross-affiliate group on process, best practices, candidate experience, time management).

• Facilitated in sourcing of Covid-19 Rapid testing to meet the need of the community. ET 2

Abbott, Sylmar, CA (hybrid)

Global Clinical Operations Manager September, 2014- March, 2020 Responsibilities

• Created and maintained project management procedures, structures, plans, and templates.

• Oversight of upcoming projects, working with division managers to ensure budgets and resources are in place.

• Provided management support for developing operating models in support of new global studies from a budgeting and resourcing standpoint along with the global study and operations managers.

• Contributed to the development and utilization of the Trial Master File (TMF) systems.

• Developed self and supported others to achieve full potential by exploring online or in person courses; exploring learning opportunities by speaking to management for my staff.

• Delivered initiatives in a highly matrixed project and functional environment, performance within budget, timelines, and other project commitments (using MS Project).

• Communication with sponsors/CROs regarding project timelines, resources, and contracts.

• Ensured alignment between strategic management goals and day-to-day operational functions and deliveries.

• Tracked and analyzed patient data for completeness for database lock and committee review boards.

• Overseen physician clearance and site activation activities.

• Ongoing training and mentoring of junior colleagues, new employees, and ensuring the entire team is on track; provide support and guidance to business partners on best in class customer service.

• Managed a Global team of 31 people in a key global operations group (clinical study coordina- tors) that provided administrative support for the study management teams, sites, and hospitals.

• Identified opportunities to improve collaborative business planning process.

• Handled all aspects of employee recruitment and onboarding including employee recognition and rewards as part of employee retention, development initiatives, and evaluations.

• Collaborated on a cross-affiliate team to develop the Talent Acquisition strategy and initiatives to attract and recruit talent in both locations (aligning cross-affiliate group on process, best practices, candidate experience, time management).

Major Achievements

• Developed Product Return Forms for Field Personnel to improve device return process.

• Trained Field Personnel on new internal Device Accountability Reports.

• Co-developed Device Accountability Manual of Operations.

• Co-developed and created a Taskforce for internal auditing quality management system that allowed tracking and filing of all audit related information.

• Defined metrics to measure progress against business priorities, setting processes for consistent reporting, and ensuring effective delivery and communication for executive management.

• Developed Manual of Operations and Work Instructions for the Clinical Study Coordinators.

• Developed an onboarding checklist to ensure all training for new employees were on track.

• Developed a site activation checklist and Work Instructions for study trials in Europe.

• Created a Taskforce and co-developed a database to easily retrieve regulatory documents for audits.

• Created a Taskforce and co-developed a database to automate regulatory binders for sites in Europe (using TMF systems).

ET 3

St. Jude Medical, Inc., Sylmar CA

Sr. Clinical Study Coordinator December, 2008 - September, 2014 Responsibilities

• Coordinated all of the study activities such as trial master files (TMF), various meetings and meet- ing minutes, AE/SAE source packets, regulatory and subject binders for sties.

• Assisted CRAs with site activation checklist requirements, regulatory, and patient needs.

• Worked with the legal department to create consulting agreements for CEC, DSMB, and Steering Committee members.

• Collaborated with vendors (e.g. hotels, restaurants, conference venues, Airport Conference rooms) to set-up meeting needs along with agreements.

• Completed the global review of eligibility requirements (OCR) prior to site selection, PI’s, CO-PI’s, IRB/EC, Steering Committee, and communicating results to Project Managers.

• Participated in interviewing new talent and candidate selection discussions. Major Achievements

• Co-led harmonization of Global ICF Procedure.

• Developed harmonization of processes across studies.

• Developed Work Instructions for onboarding new employees.

• Partnered with CRA Managers in establishing quarterly CRA/CSC seminars to enhance training.

• Established partnership with a print vendor with high quality work and low cost for the company.

• Assisted clinical teams with preparation of approximately ten Sponsor GCP Audits that included review of subject charts, regulatory files and training records that resulted in audit with non-critical findings.

• Developed training program for junior Clinical Study coordinators on FDA Regulations, protocol implementation and compliance, good documentation practices, GCP Audits and training requirements.

EDUCATION

• Master of Business Administration, University of Phoenix, 2012

• Bachelor of Business Marketing, University of Phoenix, 2010 Software: MS Office, Oracle Clinical, EDC, Adobe Acrobat, T.I.M.E, TimeForce, Workday ET 4

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