Job Summary: 

• Manage project timelines and quality of deliverables from vendors
• Manage approved trial budgets throughout the life of the assigned clinical trials
• Manage the clinical trial conduct under the direction of the project leader
• Participates in the selection of study vendors
• Monitor CRO performance and provide guidance
• Develop the study monitoring plan in collaboration with vendors and study timelines
• Contributes to clinical protocol drafting, amendment, clinical data compilation, cleaning, and clinical study reports
• Contributes to study data review and other review activities as assigned
• Oversees clinical trial sites' adherence to pertinent regulations through review of monitoring reports, CQA-GCP audit reports, communications with investigators, study site personnel, CRAs, and other CRO/designee personnel
• Identifies and provides solutions to clinical trial issues and/or risks

Skills on Resume: 

• Project Management (Hard Skills)
• Budget Management (Hard Skills)
• Vendor Management (Hard Skills)
• Clinical Trial Conduct (Hard Skills)
• Monitoring and Guidance (Hard Skills)
• Study Planning and Collaboration (Hard Skills)
• Clinical Data Management (Hard Skills)
• Regulatory Compliance (Hard Skills)

Job Summary: 

• Develop, review and contribute to the study
• Protocols, eCRF design and completion guidelines, laboratory manuals, Informed
• Consent Forms, project plans and other study-related documents.
• Vendor selection and management
• Training site personnel on study protocols
• Attend co-monitoring site visits when required
• Perform review and QC central clinical files and TMF.
• Track and coordinate clinical trial supplies and laboratory samples.
• Provide training to vendors on assigned protocol-specific topics
• Manage the vendor, invoicing and billing
• Use project management tools to communicate and supervise activities
• Plan, execute and lead study-specific meetings (e.g. project management meetings, investigator meetings, steering committee meetings, etc.)

Skills on Resume: 

• Clinical Trial Documentation Management (Hard Skills)
• Vendor Selection and Management (Hard Skills)
• Training and Oversight (Hard Skills)
• Quality Control and Compliance (Hard Skills)
• Logistics and Coordination (Hard Skills)
• Vendor Training (Hard Skills)
• Financial Management (Hard Skills)
• Project Management (Hard Skills)

Job Summary: 

• Execute and manage all aspects of multi-center global clinical trials independently from concept to close-out within designated project budgets and timelines
• Develop clear and measurable project management plans and establish project metrics
• Provide leadership for the clinical operations project team, work in close collaboration with the CRA and other functional group leaders for the execution of all services according to the project-specific scope of work
• Ensure clinical studies are conducted according to all applicable regulations, company procedures, and high ethical/quality standards allowing for clinical trial documentation to be in audit-ready condition
• Prepare and/or facilitate the review of case report forms, protocols, investigator's brochures/instructions for use, informed consent forms, study operations manuals and regulatory reports
• Assist in the development of electronic data management and device management systems
• Assist in the submission and review of all clinical deliverables required for regulatory submissions
• Support selected investigative sites for IRB/IEC/REB submissions, regulatory document collection and review, and budget and contract negotiations
• Collaborate with clinical operations administration to identify and oversee trial-related training and any performance concerns of team members according to their individual needs

Skills on Resume: 

• Project Management (Hard Skills)
• Strategic Planning (Hard Skills)
• Leadership (Soft Skills)
• Regulatory Compliance (Hard Skills)
• Clinical Documentation (Hard Skills)
• Data Management Systems (Hard Skills)
• Regulatory Submissions (Hard Skills)
• Site Management (Hard Skills)

Job Summary: 

• Manages projects of varying complexity and/or multiple projects independently
• Prepare, track, and forecast milestones and project budgets
• Coordinate project materials to ensure timely provision to sites
• Manage CRO/vendor performance
• Training CRO personnel and consistent use of project-specific tools/procedures
• Track and report metrics and provide visibility of study status
• Identify and resolve recruitment or operational issues and assist in protocol amendments
• Work closely with cross-functional teams including Data Management
• Supervise and maintain control of the eTMF
• Provide all job-related progress reports/technical reports
• Assists in the implementation of project management systems and software.

Skills on Resume: 

• Project Management (Hard Skills)
• Budget Management (Hard Skills)
• Logistics Coordination (Hard Skills)
• Vendor/CRO Management (Hard Skills)
• Training and Compliance (Hard Skills)
• Metrics Tracking and Reporting (Hard Skills)
• Issue Resolution (Hard Skills)
• Cross-Functional Collaboration (Soft Skills)

Job Summary: 

• Oversee Global study sites, quality standards
• Accountability for achieving study delivery milestones.
• Develop the research strategy for delivering a high-profile research study.
• Develop and maintain key strategic relationships
• Provide trial management advice at the planning and funding application stage.
• Risk management and monitoring plans.
• Ensure protocols are following in line with ethics, regulations and data protection.
• Take responsibility for trial timelines and budgets.
• Follow and guide trial protocols, and develop written procedures for trial processes.
• Work cross-functionally to ensure milestones are met with data managers, monitors, and trial managers.
• Interact with research and development, business development, and contracts

Skills on Resume: 

• Project Management (Hard Skills)
• Leadership and Accountability (Soft Skills)
• Relationship Management (Soft Skills)
• Risk Management (Hard Skills)
• Ethics and Regulatory Compliance (Hard Skills)
• Trial Management Advice (Hard Skills)
• Process Development (Hard Skills)
• Cross-functional Collaboration (Soft Skills)

Job Summary: 

• Works closely with the Project Management team to ensure client needs and timelines are met.
• Works with Business Development, Contracts and Project Management team in the study set-up phase
• Assisting with logistics, generating protocols and study files, and preparing laboratory manuals and sample collection guidelines
• Works proactively with Operations to ensure efficient and effective project workflow and tracks the movement of samples through the lab.
• Responsible for the interpretation, documentation and reporting of results.
• Provides ongoing communication to the Project Management team and other in-house teams regarding study progress.
• Assists with study closure, and in writing and editing SOPs
• Assists the Project Management team with month-end billing, and captures requests for Additional Work.
• Works with Project Management, Operations, and Quality Assurance to ensure integrity of studies.
• Assists in the creation of reports (study-specific protocols, financial reports, QA reports, final client reports, and others).
• Assists the Project Management team in archiving data and record storage

Skills on Resume: 

• Project Coordination (Hard Skills)
• Study Setup and Documentation (Hard Skills)
• Logistics Management (Hard Skills)
• Data Interpretation and Reporting (Hard Skills)
• Communication Skills (Soft Skills)
• SOP Development (Hard Skills)
• Billing and Financial Management (Hard Skills)
• Quality Assurance Compliance (Hard Skills)

Job Summary: 

• Provide project management and business development support for clinical trials run in ANZ
• Work within the scope of relevant SOPs, protocols, ICH-GCP Guidelines and regulatory requirements
• Take responsibility for Project oversight and functional leadership of PMs 
• Be a point of escalation for high-level issues
• Take responsibility for risk mitigation, Financial negotiations
• Deliver project milestones on time and within budget
• Development and preparation of documents and reports
• Take responsibility for oversight of start-up activities, Management of study finances
• Participation in meetings and assistance with study design when required
• Collaborate with internal and external stakeholders to achieve this high level of performance
• Liaise with sponsors to update on study progress
• Be responsible for steering the project team and associated vendors in line with budget and timelines. 

Skills on Resume: 

• Project Management (Hard Skills)
• Leadership and Oversight (Hard Skills)
• Risk Management (Hard Skills)
• Financial Negotiation (Hard Skills)
• Document and Report Preparation (Hard Skills)
• Study Start-Up Management (Hard Skills)
• Stakeholder Collaboration (Soft Skills)
• Communication and Escalation (Soft Skills)

Job Summary: 

• Responsible for overseeing, supporting and supervising the CRO partner involved in the management of the trials.
• Ensure adherence to established guidelines and standards, such as GCP regulations, resulting in a high-quality output.
• Support data management activities to report data obtained from previous trials.
• Lead the design and execution of consented and non-consented sample collection studies
• Lead and oversee external sample collection and assigned resources
• Participate in internal and external clinical cross-functional project teams to ensure that the clinical program effectively supports the overall assay product development program objectives within approved budgets and committed timelines.
• Write or supervise the writing of study protocols and study reports or summaries.
• Identify and select Principal Investigators, external service providers and sample collection sites.
• Monitor study costs and coordinate/track payments.
• Manage clinical project expenses within the approved budget.

Skills on Resume: 

• Clinical Trial Oversight (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Data Management (Hard Skills)
• Study Design and Execution (Hard Skills)
• Resource Management (Hard Skills)
• Cross-functional Collaboration (Soft Skills)
• Protocol and Report Writing (Hard Skills)
• Vendor and Site Management (Hard Skills)

Job Summary: 

• Provide management of full-scope clinical trial projects including global trials from start-up through the analysis phase
• Provide oversight of functionally assigned team members on clinical trial projects, manage multiple projects simultaneously.
• Provide coordination of a clinical trial project including organization, implementation, and management of scoped activities.
• Set goals and timelines, provide oversight and foster motivation within the team to accomplish goals within defined timelines and with high quality in the execution of assigned clinical trials.
• Plan, implement, evaluate, and complete full execution of assigned clinical trials, functioning as a global trial lead.
• Provide day-to-day oversight of Clinical Research Associate (CRA) tasks on assigned projects
• Provides oversight of the CRA’s management of sites and monitoring of the clinical trial data 
• Review and approve site trip reports and escalate site issues
• Lead client and team meetings to enable effective information sharing, discussion and decision-making
• Ensures accurate and complete documentation of the meeting discussions, decisions and outcomes.

Skills on Resume: 

• Project Management (Hard Skills)
• Team Leadership (Soft Skills)
• Clinical Trial Coordination (Hard Skills)
• Strategic Planning (Hard Skills)
• Global Trial Leadership (Hard Skills)
• Clinical Research Oversight (Hard Skills)
• Quality Assurance (Hard Skills)
• Communication and Collaboration (Soft Skills)

Job Summary: 

• Communicate with the Sponsor and other parties involved about project strategy and progress, timelines, issues, questions, etc., and provide regular study updates
• Ensure the development of various project-specific plans, such as project plan and monitoring plan
• Planning and tracking of site activities, such as site selection, site visits, site management, co-monitoring and site close-out
• Manage communication between various departments and the Sponsor
• Head project team meetings, sponsor meetings and other clinical staff meetings
• Represent the company externally where it concerns the Clinical Department
• Identify training requirements and provide training on the job to (new) personnel and trial-specific tasks.
• Identify (potential) resource issues within the Clinical Department and report to the Management Team
• Assist Management Team in selecting, managing and evaluating contractors/Suppliers where it concerns the Clinical Department
• Assist the Management Team with a selection of new (internal or external) clinical staff, and the performance of job appraisals of clinical staff
• Prepare PM update report Financial, and perform a budget review of ongoing studies 
• Assist the Management Team in preparing budgets and forecasts Bid defense participation Quality Assurance

Skills on Resume: 

• Project Management (Hard Skills)
• Communication Skills (Soft Skills)
• Leadership and Team Management (Hard Skills)
• Stakeholder Management (Hard Skills)
• Resource Management (Hard Skills)
• Vendor and Contractor Management (Hard Skills)
• Budgeting and Financial Management (Hard Skills)
• Quality Assurance and Compliance (Hard Skills)