Oversees the development and implementation of targeted recruitment, retention and site engagement strategies that will encourage DEI and patient centricity as well as drive enrollment and maintain patient retention. • Oversees the development of innovative patient recruitment/retention and site engagement tactics for complex studies through analyzation of country and competitive landscape, disease prevalence and lessons learned.• Ensure proper DEI representation and patient centricity and providing direction to all relevant internal and vendor teams. Tactics implemented may include but are not limited to: collateral materials, digital media, advocacy group/physician/patient outreach, websites, technology-based retention services, physician communications and pre-screeners, patient travel and reimbursement and clinical enrollment managers.• Leads study teams in utilizing study-specific enrollment programs to optimize recruitment in order to meet on-time enrollment goals through leveraging strategic partnerships such as Patient Advocacy, Site Alliances, and Patient Insights.• Monitors project budgets for service fees, pass-through expenses and hours charged to ensure accuracy. Monitors invoices to ensure vendor expenses are within the project awarded budget. Tracks project expenses and shares financial information with management to ensure project spend is on target with budget milestones.• Manages the analysis of recruitment metrics to identify trends, issues, areas of success and areas for improvement and the overall impact of the tactics implemented.• Conducts Return on Investment (ROI) and Key Performance Indicator (KPI) analyses on recruitment tactics; reports back to the team and recommends refined outreach plan based on analysis.• Attends Parexel/Sponsor meetings such as bid defense meetings, Kick Off Meetings, capabilities presentations and Investigator Meetings to present key patient recruitment and retention presentations and training.

Accountable for the management, execution and timely delivery of tactics and materials for patient recruitment and retention and site-facing initiatives for Oncology clinical trials. • Provide the development of tools and tactics to engage sites in clinical trial project enrollment.• Oversee the translations of tools and tactics as listed in the SOW.• Manage the vendors involved and set clear expectations regarding deliverables, timelines and costs.• Responsible for understanding and applying Janssen finance and contracting systems to include budget management and forecasting.• Execute different scenarios in recruitment tools and tactics management: amendments, rescue situations, added countries and sites, adaptive design, non-template requests, as defined in the updated SOW.• Lead site calls to discover and overcome roadblocks in enrollment and ensure effective use of recruitment/retention tools and tactics.• Responsible for timely patient recruitment/retention, generating patient recruitment/retention materials and analyzing effectiveness.

Responsible for all aspects of enrollment optimization by providing global patient enrollment and retention solutions, within a network of dedicated research sites.• Direct accountability for project revenue and financial targets across assigned projects of Acurian and applicable AES contracts.• Manage within framework and metrics for operational client delivery performance.• Manages relationships with partners/vendors.• Provide enterprise wide cross-functional leadership in all aspects of assigned project revenue generating contract delivery. • Utilize analytical frameworks for troubleshooting and identifying route causes for all aspects of client delivery performance failures.• Recommend and implement corrective actions.• Drive continuous improvement and optimization of business processes in support of delivering client clinical study patient recruitment through randomizations.

Responsible for coordinating and managing all of the efforts necessary for creating and presenting an integrated strategy for strategic scenario planning for each study or program by producing feasibility proposals and reports.• Conduct high level recruitment benchmark data analysis to estimate the basic foundations for the enrolment scenario building, namely range of countries and sites as well as months of recruitment required to enroll the target patients including efficiencies across studies and programs.• Identify potential challenges/risks associated with Sponsor specifications if any.• Understand the patient profile and where these patients are found in the healthcare section based on critical data, recognizing the global nature of the study. Identify site and patient barriers and motivators to participate in this study. • Conduct country selection analysis via available country selection tool/platform and deliver protocol-specific country recommendations including solid data-driven rational.• Define optimal strategy for site identification that would allow maximizing number of patients per site as well as number of sites per country.• Lead the development of an integrated operational strategy to successfully recruit patients for clinical trials and deliver enrolment scenarios aligned to the agreed strategy utilizing available modeling tools and techniques.Develop strong selling proposal text to deliver the agreed compelling strategic approach to meet optimum delivery plan taking into account Sponsor specific requirements.• Attend Bid Defense Meetings to present the integrated strategy to support the winning of new business.

Oversee and manage global clinical trials by effectively managing project teams, communications, risk, scope, schedule, cost, quality, and stakeholders ensuring that quality patients are enrolled and monitored within timelines and that client expectations are met. • Maintain and evaluate project progress by managing timelines and other tracking/analysis tools. Produce and distribute status, resourcing and tracking reports and functional area plans to appropriate team members and senior management.• Review study budgets, expenses and financial status to ensure all study related contractual and budgeting issues are resolved and alert senior management to potential issues, ensuring necessary corrective action is taken.• Conduct key therapeutic/protocol on boarding/training of new staff.• Ensure that work is conducted in compliance with standard processes, policies and procedures and meets quality and timeline metrics.• Develop and maintain project plans for the study in accordance with SOPs and work instructions.• Identify and negotiate out of scope project work.• Lead a global team of CRAs to on time monitoring and successful and timely enrollment and ensure that quality monitoring visit reports are submitted for approval.• Overseeing the regulatory document collection and submission process. • Evaluate site performance to ensure that poorly performing sites are educated, retrained and supported resulting in highly performing investigative sites.• Ensure CRAs are meeting deadlines regarding CRF collection, DCF resolution, protocol deviation resolution and collection of regulatory and protocol specific documents from sites.• Work with Sponsor, CRA and QA for CAPA creation and full resolution of items.• Work collaboratively with contracts and business development to respond to RFPs considering operational strategy and therapeutic experience.• Attend bid defense meetings as the face of inVentiv Health Project Management.

Same description and duties as above.• Ensure industry best practices consistent with all applicable guidelines and regulations.• Ensure quality patients are enrolled based on protocol inclusion/exclusion criteria.• Act of point of escalation for team and sites to resolve/overcome any barriers affecting performance in the clinical trial.• Conduct clinical site shadow visits with the clinical research associate assigned to ensure site engagement, protocol adherence and good site relations.• Ensure the timely entry and collection of CRF data in accordance with the monitoring plan.• Along with the CRA, ensure sites are meeting the SRAP (Site Recruitment Action Plan) goals, identify short comes and risk mitigation to get sites back on track in enrollment.• Attend bid defense meetings.• Work with sites to resolve outstanding issues.

Same duties described above.

• Duties as described above.• Lead two orphan drug studies. One as Associate Project Manager on a Lennox-Gastaut Syndrome (LGS) study and as acting North America Project Manager on an Unverricht-Lundborg Disease (ULD) study.

Responsible for managing clinical trial operational and financial risk from award through closure and escalating high risk projects to senior management along with a corrective action plan ensuring rapid recovery and effective recovery.• Lead efficient and effective communications and work flow for a matrix environment project team and their assigned projects.• Attend Hand Off and Kick Off Meetings with the PPD team and Sponsor for team support.• Key contact with the Director and Project Manager at the initial study set-up. • Identify and track project timelines, specifications and budgets based on the client contract and modifications.• Provide analysis of common issues (lessons learned) amongst client specific projects and indication.• Facilitate Global Project/Executive Review Meetings with the project teams and VPs for high risk projects to identify current and potential risks for ongoing trials related to quality, financial and operational performance and prepare a Risk Assessment identifying the severity of the risk as well as actions being taken to rectify it.• Facilitate Post Study meetings to review the contracted milestones and specs with the project team and facilitate a discussion of obstacles experienced and how we overcame them.• Provide a Financial Executive Summary to senior management including the contract value, financial variance and gross profit information based on the most recent bid, contract and payment schedule.

Provide administrative support to the project team through assistance with the collection and management of important clinical trial documents and reports.• Interact with sponsors to keep them informed of the status of the study. • Work with study coordinators and physicians to update and maintain records at the site. • Assist physicians in accurately completing required FDA and regulatory documents and in the use of our internal IVRS (Interactive Voice Response System) to ensure proper drug distribution. • Assure proper records are maintained on site. • Audit study and site documents to ensure that they follow proper ICH/GCP guidelines.