Djarta Halliday

Owner and CEO @Phoenix Orchid Consulting, LLC

CRO OversightStudy ManagementClinical ResearchStudy Start UpOperational StrategyMonitoringFeasibility and Site SelectionClinical OperationsSite ManagementCSR Review and DevelopmentVendor ManagementClinical TrialsBusiness Owner🧨 Consulting

Award-winning, results and solutions-focused, experienced clinical trials professional with extensive industry experience in clinical project management, operational team management, clinical site monitoring, study start-up and maintenance. Multilingual, fluent proficiency in Spanish and Portuguese. Highly adaptable and creative, skilled in regulatory document review and submission, informed consent review, and contract and budget negotiation. Demonstrated excellence in customer focus, on-time delivery, and keen financial management. Demonstrated ability to promptly learn and apply new policies, procedures, and information according to ICH/GCP guidelines for national and international compliance, adjust to rapidly changing requirements and regulations. Creative, “no-nonsense”, democratic leader of global clinical trials in multiple therapeutic areas including infectious disease (RSV, COVID), NASH/NAFLD, rare disease, oncology, diabetes, and gastroenterology. Self-motivated, driven, and personable with exceptional interpersonal oral and written communication skills. Values transparency, respect, professionalism, mutual accountability, autonomy, and cross-functional collaboration.

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Work Background

Phoenix Orchid Consulting LLCOwner

Apr. 2024United States

PfizerGlobal Study Manager II (Senior Manager)

Jun. 2021Charlotte, North Carolina, United States

ProSciento, Inc.Clinical Project Manager II

Apr. 2019 - May. 2021Charlotte, North Carolina AreaMentored and managed Clinical Project Managers supporting full service single and multi-site CRO Services projects; Led business process improvement initiatives contributing to continuing development of the department and to efficiency gains; Participated in site qualification activities and oversight of general performance; Developed processes and tools in support of project management, including set up and oversight and vendor management, for multi-center trials as well as full service internal projects; Provided input during proposal and contract development, including project budgeting and timeline development; Planned, directed, and coordinated new processes and process improvement initiatives; Improved the performance, productivity, efficiency, and profitability of departmental and organizational operations through the provision of effective methods and strategies; Provided subject matter expertise, advice, and project management support on selected aspects of clinical trial development and execution; Problem solved clinical situations along with heads of CRA Services, as required. Provided recommendations for solutions and developed process improvements as appropriate to prevent reoccurrence; Assisted in the creation, development, and execution of Standard Operating Procedures (SOPs), Work Instructions (WIs), associated documents, and guidelines; Created and supported strategic and tactical plans for company growth; Attended Project Pipeline Launch Team meetings and any other project/implementation meetings as required; Managed and oversaw various client portfolios for multiple studies/compounds.

IQVIAClinical Project Manager

Jun. 2018 - Apr. 2019Parsippany, New Jersey (Remote)Managed and co-ordinated efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles and ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures. Developed study management plans, together with team assignments and accountabilities and oversight of database maintenance. Provided input for the development of proposals for new work and manage project budgets. Participated in proposal development and in the bid-defense process with guidance and supervision; Served as primary project contact with Sponsor to ensure communication is maintained and reporting schedules are adhered to. Collected information on team performance against contract, customer expectations, and project baselines. Led problem solving and resolution efforts to include management of risk, contingencies and issues. Identified quality issues within the study to implement appropriate corrective action plans. Escalated findings and action plans to appropriate parties; Provided input to line managers of their project team members’ performance relative to project tasks. Prepared and presented project information at internal and external meetings. Ensured high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site/visits and ongoing mentoring of CRA team.

IQVIAAssociate Clinical Project Manager

Oct. 2015 - Jun. 2018Parsippany, NJ (Remote)

PRA Health SciencesClinical Project Management Associate/In-House Clinical Research Associate II

Nov. 2013 - Oct. 2015Bridgewater, NJEmbedded in the North American Clinical Studies Unit of one of our strategic partners providing support to the Oncology clinical project team including, but not limited to: eTMF Training, Regulatory Document Review training, eTMF and regulatory document review, preparation of site files for SIV, preparation and administration of study-related documents, coordination of investigational product and supplies (clinical and non-clinical), maintenance of IND safety-related communications, and acting as liason between sites, vendors, and project teams for investigator/site payments, language translations, and appropriate training.

CovanceSpecialist I, Site Activation, Global Site Services

Jan. 2012 - Nov. 2013Greater New York City AreaEngaged in all aspects of the site activation process including contract and budget negotiation, feasibility, informed consent development and review, site management within CTMS, and the collection, distribution, and review of regulatory documents for active and maintenance sites.