Samuel Quek

Leadership:

• Leads and coordinates execution of clinical trial from Study start-up through Database release and inspection readiness to ensure timely delivery of quality study data.
• Additionally, ensure delivery & compliance with all applicable Standard Operating Procedures (SOPs) and Quality Standards. Study Managers may also provide input to support compilation of sections to Clinical Study Reports.

Project Finance:

• Builds and manages CRO (study management/monitoring) and Study Management vendor elements of Clinical Trial Budget
• Responsible for day to day management of CRO and study management spend via functional vendor invoice review and approval which may include Central Labs, ECGs, Translations, etc.
• Accountable for reviewing, negotiating, and confirming study work orders and change orders

Project Accountability:

• Accountable for development of realistic detailed study startup and monitoring plans
• Accountable for conducting country level feasibility in collaboration with Global Clinical Trial Execution and CROs, reviewing Pre-trial Assessment outputs, approving sites, and assessing site activation plans
• Leads study risk planning process in context of site and subject single point of accountability for detailed study start-up and monitoring plans and for delivery to the agreed plans.
• Works with functional lines and directly with CRO line functions to resolve or triage site level issues.
• Drive decision making and work closely with Clinical Study Team Lead to provide input to operational strategy.

Quality:

• Technical expert for study management systems and processes, champion implementation and use of harmonized, consistent processes and excellence in Study Management deliverables related to cost-effective, timely, and high-quality clinical trial data according to agreed global goals.

Vendor Management:

• Quality oversight to Contract Research Organization (CRO) and of CRO deliverables related to study execution. Core member of Study Team and will represent CRO on matters of study execution.
• Responsible for selection of CROs and SM functional vendors including competitive bid process in collaboration with Outsourcing Lead
• Approves & oversees drug supply management – manages flow of drug supply to sites and set up Interactive Voice Randomization System with Supply Chain Lead

• Responsible for training and development of Clinical Team Managers to ensure optimal performance, compliance with PRA systems and processes, and development of effective leadership skills
• Monitors performance in client/internal project team
• Creates specific development plans focused on enhanced performance
• Participates in development and deployment of functional area training
• Responsible for oversight of delivery of clinical project deliverables within time and cost and contracted quality
• Reviews status of clinical deliverables for all line reports with focus on risk, quality and financial management
• Serve as primary point of contact for clients and PM, providing regular updates on trial progress and addressing any concerns.
• Build and maintain strong relationships with key stakeholders, including team members, different departments and PMs
• Supports development of mitigation plans with effective escalation
• Participates in corporate/functional initiatives as requested
• Role of Country Consultant (CC) for Vietnam and Indonesia, responsible for quality of country intelligence available in Vietnam and Indonesia
• As Country Consultant; liaise with pre-determined experts from PRA's operational departments to maintain country intelligence in Vietnam and Indonesia
• As Country Consultant, responsible for creation and maintenance of Vietnam and Indonesia specific training courses
• As Country Consultant; assist in BD/audit and project specific activities if particular intelligence is required for Vietnam and Indonesia
• Led teams of up to 16 personnel, supervising daily performance as well as training and improvement plans

• Project Finance: provides Time Entry Guidelines to the clinical team in adherence with scope / budget, monitor burn rates, escalating issues and potential solutions to PM; forecasts units / hours / generic resources for start up and monitoring activities, analyzes forecasted and worked activities to ensure adherence to contract and budget; identify /escalate any out of scope activity
• Review of monitoring reports, study related communications and participation at routine meetings; coordinating study assigned tasks
• Work with CRAs in preparation for study site audits and in providing responses to audit findings
• Training & Development: creates clinical project documents; plans, oversees, and conducts study specific training for the team; responsible for site monitoring activities (tracking and resolution of issues, review and approval of reports, co-monitoring visits, tools preparation)
• Accountable for achieving successful delivery of clinical activities (site selection, site start up and site monitoring) by meeting internal and external (client & regulatory) requirements according to time, quality/scope and budget constraints
• Quality: supervises IP accountability, subject screening/enrollment, CRF retrieval, and query resolution; ensures all PRA project reporting systems are up to date for the clinical part; collaborates with QA to identify sites needing corrective and preventative action plans, responds completely and accurately to audit reports
• Project Oversight & Leadership: leads and manages the clinical team; works with the PM to facilitate cross functional team and sponsor communication; oversees start-up activities; provides performance / project status metrics; identify issues and risks to clinical activities and develops contingency / mitigation plans; reviews filing of Essential Documents in the electronic TMF
• Customer Relations (Internal and External): interfaces with other Functional Leads, vendors and client as required to ensure clinical monitoring outcomes are achieved; serves as primary liaison for clinical monitoring issues, interacting with clients, vendors and other PRA functional areas; participates in client meetings, assisting with presentations as required
• Project Resourcing: takes active part in clinical resource request process; liaises with Clinical Operations Managers to resolve resource and performance issues; effectively manages clinical monitoring resources throughout the study; oversees transition plans

• Oversee and supervise CRAs, corresponding with study lead, Data management in the execution of trial activities
• Work with CRAs in preparation for study site audits and in providing responses to audit findings.
• Forecast trial resources requirements and tracking of trial budget
• Train CRAs on project specific matters, review monitoring visit reports and conduct co-monitoring visits
• Experienced in management of CRO for studies
• Study budget management and contract negotiation with site and third party vendors
• Review of monitoring reports, study related communications and participation at routine meetings;coordinating study assigned tasks
• Implementation of clinical trials, as well as reviewing and identifying status, performance metrics and provide project reports
• Participates in Investigator selection, recruitment of subjects and training and provides final recommendations
• Assessment of the trial feasibility and site selection activities

• Completed site evaluation and visit reports as appropriate.
• Maintained Site files and Investigator Site files as appropriate
• Assisted with the development of study specific monitoring plan, annotated CRFs, monitoring conventions, tracking forms, and other study related documents.
• Managed the collection, reviews and tracking of regulatory documents and EC approvals.
• Facilitated study documents archival with local storage services Initiated patient enrolment strategies with the project team and study sites.
• Performed Feasibility studies for potential study sites, reviewing regulatory requirements, patient potential pool, training of site staff and site logistics.
• Familiar with Regulatory guidelines of India, Malaysia, Singapore, Thailand, Indonesia, Hong kong
• Ensured proper storage, dispensation, accountability and destruction of all investigational product(s) and trial-related material.
• Performed monitoring visits to ensure the integrity of clinical data and appropriate follow up procedures, including source document verification, drug storage, accountability procedures and SAE reporting in accordance with project plan.
• Administered the completion and submission of study dossiers to the Ethics Committees when required.
• Responsible for performing Site initiation, monitoring and close-out activities while adhering to all applicable regulatory and Standard Operating Procedures (SOPs) and Project Specific Operating Procedures (PSOPs).

• Responsible for data queries management, study progressing and quality control check of the files
• Involved in the feasibility, site selection, pre-study visits at site
• Conduct the clinical monitoring aspect of designated projects in accordance with applicable SOPs and regulations
• Handle independently clinical trial budgets and site locations/other administrative matters.
• Act as the main line of communication between the sponsor and the investigator.
• Collect regulatory documentation for study Versed in investigator’s training, ICH-GCPs, current monitor guidelines, local regulations and SOPs
• Perform clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, data collection)
• Conducted clinical trial in accordance with protocol and recorded and monitored progress
• Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality
• Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues
• Gathered and organized clinical trial documentation to meet rigorous standards for site approval