Darci Yuska
Laguna Niguel,CA
Summary
Over 21 years of experience in clinical research and managing numerous research protocols.
Qualified Clinical Operations Manager with proven track record in leading teams and driving operational efficiency. Demonstrated ability to implement strategic initiatives that enhance productivity and foster growth. Known for utilizing strong leadership and communication skills to facilitate team collaboration and achieve organizational goals.
Phase II, III, IV -experience in the following therapeutic areas:
- Medical Device
- Critical Care
- Melanoma
- Breast Cancer
- Lung Cancer
- Leukemia
- Multiple Myeloma
- Atopic Dermatitis
- Psoriasis
- Ulcerative Colitis
- Type 1 Diabetes
- Red CABG
- Stuttering
- Parkinson’s Disease
- Adult Schizophrenia CNS:
- Generalized Anxiety Disorder
- Adolescent and Adult Bipolar Pediatric
Additional Skills and Qualifications
- Computer skills include: Microsoft Office Suite
- Various CTMS, eTMF, ED systems
Overview
22
22
years of professional experience
Work History
Senior Manager, Clinical Operations
ICON
Laguna Niguel, CA
04.2022 - 02.2025
- Primary point of contact for Clinical Trial Managers and Clinical Operations aspects of designated projects and responsible for developing successful working relationships with clients
- Responsible for planning, scheduling and implementing the Clinical Operations aspects of projects
- Provide direction and support to the Clinical Operations study team
- Track Clinical Operations project deliverables using appropriate tools
- Contribute to the development and maintenance of cross functional project management plans
- Responsible for managing the US Clinical Operations CTM team, including ensuring all necessary project training is provided to assigned staff
- Responsible for overseeing CTM resourcing and allocations to projects
- Actively identify opportunities for process improvement
- Lead and participate in process improvement initiatives, as assigned and promote the sharing of best practices
- Lead clinical resources in a matrix environment
- Set expectations for the study team and drive a performance culture through their teams
- Develop staff skills, encourage career growth and provide regular performance feedback
- Act as mentor and help to train junior staff
- Communicate expectations, set clear goals and objectives for studies to clinical team members
- Ensure teams are aware of progress to goals and against expectations
- Lead by example and motivate all assigned team members
- Improved team performance by providing comprehensive training and fostering a collaborative work environment.
- Collaborated closely with peers from other departments to drive organizational success jointly as one cohesive unit.
- Conducted performance evaluations, compensations and hiring to maintain appropriate staffing requirements.
- Consistently met or exceeded annual performance targets set by senior leadership.
Principle Clinical Trial Manager
Syneos (Inventiv Health Clinical)
Philadelphia, PA
10.2021 - 04.2022
- As defined by scope, may be responsible for team member clinical/site management project deliverables as the clinical functional team leader
- Drives and manages the clinical and site management aspects of assigned project/program
- Reviews the project scope of work, budget and protocol content and ensures the clinical project team (CRAs/CMAs/SMAs) is aware of the parameters
- Escalates to the PM any clinical/site management deliverables (timeline, quality, and budget) at risk, and any activities and requests which are out of contracted scope
- Owns performance of clinical operations activities, including identification of out of scope activities
- Implements scope for global review of Clinical Trial Management System (CTMS), Case Report Form (CRF), drug management, safety, Trial Master File (TMF), IVRS/IWRS enrolment, Strategic Data Monitoring (SDM) and/or other dashboards to oversee site and project team conduct, to ensure timely entry of all operational aspects (required visits, duration, and frequency) according to plan, and identify any risks to delivery or quality
- Identifies trends and issues across projects via these reviews
- Actively uses leadership skills to coach and mentor Sr CTM and Jr CTMs and/or clinical operations team regarding functional clinical delivery, evaluation of study risks, and action implementation
- Coordinates trends and evaluation of risks across the portfolio
- Also sets priorities for the clinical operations team members to complete and manage on a regional and study level
- Ensures global and/or regional quality of the clinical monitoring and site management deliverables within assigned projects and/or program and maintain proper visibility of its progress by the use of approved processes, systems and/or tracking tools
- Development of the Clinical Management Plan (CMP)/Site Management Plan (SMP)
- Manages SrCTM and Jr CTM’s review of the content and quality of site monitoring documentation (site monitoring calls, site visit reports, site letters, and pertinent correspondence), to ensure they represent site management activities and conduct
- Actively manages KPIs related to performance, deliverables, and quality at program/portfolio level
- Interacts with the client and/or other functional departments related to clinical monitoring/site management activities and deliverables
- Is the client's primary POC for the clinical monitoring function in the client's portfolio
- Collaborates with other functional areas to ensure site compliance and delivery according to protocol, ICH/GCP/GPP and country regulations, including medical monitoring, oversees compliance according to scope for the development and delivery of initial and ongoing training to the project team regarding protocol specificities, Case Report Form (CRF) completion, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the project
- Participates in planning and/or leading regular clinical project team calls to provide status updates, ongoing training and accountability to deliverables
- Develops and executes corrective action plans at portfolio level to address any issues
- Participates in business development activities including the development of the clinical operations/site management strategy and budget development, proposal responses, defense meetings and any decision making/kick off meetings
- Developed training materials for site staff to enhance their understanding of the study protocol, resulting in improved adherence to requirements.
- Fostered strong relationships with investigative sites, leading to increased collaboration and improved study outcomes.
- Mitigated risks in the clinical trial process by proactively identifying potential issues and implementing corrective actions.
- Managed cross-functional teams to ensure timely completion of clinical trial milestones and deliverables.
- Achieved successful recruitment targets by implementing strategic patient enrollment plans and collaborating with study sites.
- Championed continuous improvement initiatives within the organization by sharing best practices and lessons learned from previous trials with colleagues and team members.
- Facilitated clear communication between study teams, sponsors, and investigators to maintain alignment on project goals and expectations.
Senior Clinical Trial Manager
Syneos (Inventiv Health Clinical)
Philadelphia, PA
10.2017 - 10.2021
- Ensure quality of the clinical monitoring and site management deliverables within a project and/or program and maintain proper visibility of its progress by the use approved systems and/or tracking tools
- May include the development of the Clinical Management Plan (CMP)/Site Management Plan (SMP)
- Interact with the client and other functional departments related to clinical monitoring and site management activities and deliverables
- May participate in business development activities including project clinical operations/site management strategy and budget input, defense meetings and proposal development
- As required, provides development and delivery of initial and ongoing training to the study team regarding protocol specifics, Case Report Form (CRF) completion, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the project
- Plans and leads regular clinical project team calls to provide status updates, ongoing training and accountability to deliverables
- May evaluate staff’s competency to perform visits/site contact independently via sign-off visits and Performance Assessment Visits (PAVs) according to company standards and process
- Coaches and mentors CTMs regarding functional clinical delivery, evaluation of project risks, and action implementation
- Also sets priorities for the CTM team to complete and manage on a regional and site level
- Globally reviews Clinical Trial Management System (CTMS), Case Report Form (CRF), drug management, safety, Trial Master File (TMF), IVRS/IWRS enrollment, Strategic Data Monitoring (SDM) and/or other dashboards to oversee site and project team conduct, ensures timely entry of all operational aspects (required visits, duration, and frequency) according to plan, and identifies risks to delivery or quality
- Reviews the content and quality of site monitoring documentation (site monitoring calls, site visit reports, site letters, and pertinent correspondence), to ensure they represent site management activities and conduct
- Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines
- Understands the monitoring strategy required for the project and, where required, participates in the development of the project risk assessment plan
- Is accountable for the clinical teams’ understanding, ongoing compliance and delivery, according to the stated monitoring strategy, CMP/SMP, and risk plans
- As defined by scope may be responsible for team member clinical/site management project deliverables as the clinical functional team leader
- Drives and manages the clinical and site management aspects of assigned project
- Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/CMAs/SMAs) is aware of the parameters
- Escalates to the PM any clinical/site management deliverables (timeline, quality, and budget) at risk, and any activities and requests which are out of contracted scope
- Ensure alignment of clinical activities to budget, including identification of out of scope activities
- As defined by scope may oversee the global project process and status of monitoring and data flow
- Reviews status and trends at the study level, holds CTM team accountable to manage at site and regional level for effective and timely Source Document Verification (SDV) and data flow, reviewing status of site and project eCRF entry, SDV, triggered monitoring conduct, query response, and data cleanliness
- Proactively collaborates with data management functional lead to plan towards data cut and lock deadlines
- Develops and executes corrective action plans at study (global) level to address any issues
- Fostered strong relationships with investigative sites, leading to increased collaboration and improved study outcomes.
- Championed continuous improvement initiatives within the organization by sharing best practices and lessons learned from previous trials with colleagues and team members.
- Ensured compliance with regulatory guidelines by thoroughly reviewing protocols, informed consent forms, and other essential documents.
- Achieved successful recruitment targets by implementing strategic patient enrollment plans and collaborating with study sites.
Clinical Trial Manager
Syneos (Inventiv Health Clinical)
Philadelphia, PA
04.2012 - 10.2017
- Ensure quality of the clinical monitoring and site management deliverables within a project and/or program and maintain proper visibility of its progress by the use approved systems and/or tracking tools
- May include the development of the Clinical Management Plan (CMP)/Site Management Plan (SMP)
- Interact with the client and other functional departments related to clinical monitoring and site management activities and deliverables
- May participate in business development activities including project clinical operations/site management strategy and budget input, defense meetings and proposal development
- As required, provides development and delivery of initial and ongoing training to the study team regarding protocol specifics, Case Report Form (CRF) completion, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the project
- Plans and leads regular clinical project team calls to provide status updates, ongoing training and accountability to deliverables
- May evaluate staff’s competency to perform visits/site contact independently via sign-off visits and Performance Assessment Visits (PAVs) according to company standards and process
- Coaches and mentors CTMs regarding functional clinical delivery, evaluation of project risks, and action implementation
- Also sets priorities for the CTM team to complete and manage on a regional and site level
- Globally reviews Clinical Trial Management System (CTMS), Case Report Form (CRF), drug management, safety, Trial Master File (TMF), IVRS/IWRS enrollment, Strategic Data Monitoring (SDM) and/or other dashboards to oversee site and project team conduct, ensures timely entry of all operational aspects (required visits, duration, and frequency) according to plan, and identifies risks to delivery or quality
- Reviews the content and quality of site monitoring documentation (site monitoring calls, site visit reports, site letters, and pertinent correspondence), to ensure they represent site management activities and conduct
- Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines
- Understands the monitoring strategy required for the project and, where required, participates in the development of the project risk assessment plan
- Is accountable for the clinical teams’ understanding, ongoing compliance and delivery, according to the stated monitoring strategy, CMP/SMP, and risk plans
- As defined by scope may be responsible for team member clinical/site management project deliverables as the clinical functional team leader
- Drives and manages the clinical and site management aspects of assigned project
- Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/CMAs/SMAs) is aware of the parameters
- Escalates to the PM any clinical/site management deliverables (timeline, quality, and budget) at risk, and any activities and requests which are out of contracted scope
- Ensure alignment of clinical activities to budget, including identification of out of scope activities
- As defined by scope may oversee the global project process and status of monitoring and data flow
- Reviews status and trends at the study level, holds CTM team accountable to manage at site and regional level for effective and timely Source Document Verification (SDV) and data flow, reviewing status of site and project eCRF entry, SDV, triggered monitoring conduct, query response, and data cleanliness
- Proactively collaborates with data management functional lead to plan towards data cut and lock deadlines
- Develops and executes corrective action plans at study (global) level to address any issues
Senior Clinical Research Associate
Syneos (Inventiv Health Clinical)
Boston, MA
01.2007 - 04.2012
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
- Maintained knowledge of company strategic direction, goals and objectives and aligned projects appropriately.
- Guided development of adaptive systems framework that integrated data from multiple sources to augment training and operational performance.
- Followed drug storage procedures to comply with protocols and SOP requirements.
- Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
- Enhanced patient safety through meticulous monitoring of adverse events and protocol compliance.
- Supported regulatory submissions with comprehensive documentation preparation, leading to successful approval of investigational products.
- Ensured timely completion of monitoring visits, enabling consistent oversight of site performance and adherence to Good Clinical Practice guidelines.
- Designed effective training materials for site personnel, enhancing understanding of study procedures and expectations.
- Developed strong relationships with investigators and site staff, fostering a culture of trust and open communication throughout the study duration.
- Demonstrated thorough knowledge of regulatory requirements in all aspects of clinical trial conduct, promoting compliance within assigned projects.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Clinical Research Associate
BattelleCRO, Inc
Newton, United States of America
01.2005 - 12.2006
- Conducted study qualification, initiation, interim monitoring, and close-out visits to assigned clinical sites
- Reviewed case report forms for clarity and consistency with source documents
- Reviewed and ensured maintenance of BattelleCRO and site regulatory files
- Completed and submitted monitoring reports
- Ensured accuracy of study test article inventory records
- Maintained thorough understanding of current monitoring practices and applicable regulatory requirements and guidelines
- Reviewed all regulatory documentation
- Adhered to study protocol, GCPs and SOPs
- Managed performance problems and provided re-training of clinical sites as necessary
- Monitored queries generated by data management team
- Maintained close working relationship with sites with weekly telephone contact
Clinical Research Coordinator II
Tufts New England Medical Center
Boston, United States of America
02.2003 - 12.2004
- Developed and implemented procedures for facilitating screening and patient enrollment on ECOG and Industry Clinical Trials
- Worked as a liaison between clinics and Clinical Research Coordinators in the Cancer Clinical Trials Office
- Worked in clinic areas to assist physicians in enrollment
- Pre-screened patients to determine eligibility for Cancer Clinical Trials
- Submitted new protocol applications and Continuing review applications to the Institutional Review Board
- Assisted in the development of databases
- Coordinated the follow-up procedures for patients
- Maintained regulatory paperwork; completed case report forms and queries
- Reported all Serious Adverse Events
- Conducted follow-ups on all patients
- Participated in Site Initiation Visits
Education
Master of Science - Social Work
University At Albany
Albany, NYSkills
- Phase II, III, IV
- Operations planning
- Cross-functional communication
- Talent development
- Resource allocation
- Troubleshooting and problem resolution
- Organizational improvement
- Teamwork and collaboration
- Team leadership
- Training and development
- Team development
- Multitasking
- MS office
Timeline
Senior Manager, Clinical Operations
ICON
04.2022 - 02.2025
Principle Clinical Trial Manager
Syneos (Inventiv Health Clinical)
10.2021 - 04.2022
Senior Clinical Trial Manager
Syneos (Inventiv Health Clinical)
10.2017 - 10.2021
Clinical Trial Manager
Syneos (Inventiv Health Clinical)
04.2012 - 10.2017
Senior Clinical Research Associate
Syneos (Inventiv Health Clinical)
01.2007 - 04.2012
Clinical Research Associate
BattelleCRO, Inc
01.2005 - 12.2006
Clinical Research Coordinator II
Tufts New England Medical Center
02.2003 - 12.2004
Master of Science - Social Work
University At Albany