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At Parexel, Quality Specialists act as a Quality partner for GDO Biostatistics and Statistical Programming, focusing on first-time quality, robust risk and issue management and maintaining an inspection-ready state. Provide quality expertise through the execution of quality SOPs to support operations, leadership and clients

• Manage the relationship with GDO Biostatistics and Statistical Programming
• Provide Quality input to audits/inspections
• Facilitate identification, investigation and remediation of Quality Issues (QIs) related to GDO Biostatistics and Statistical Programming activities
• Facilitate the Risk Evaluation process

Knowledge and Experience:

•  Knowledge of ICH-GCP and clinical trial regulation
•  Experience using root cause methodologies (5-whys, fishbone diagram, etc.)
•  English proficiency (written and oral) • Significant industry experience in one or more areas of PQRM support and / or Quality Management
•  IT literate - experience with Microsoft based applications and functional and TMF applications / languages / solutions. Able to embrace new technology and apply best practices

Skills:

•  Emerging ability to lead without explicit authority
•  Self-management: independent, takes initiative, proactive and organized
•  Focused on quality results - attention to detail and First Time Quality
•  Interpersonal, verbal and written communication skills including effective listening, facilitating group discussions, influencing without authority and providing appropriate feedback
•  Ability to develop professional, collaborative relationships both within Quality and with Operations (and clients where assigned)
•  Skill in interpreting, synthesizing, inferring, evaluating and extracting pertinent data to identify areas of risk, trends and aggregated issues
•  Adaptable to changing environments, able to think quickly, able to deal with ambiguity and learn new tasks applying routine knowledge
•  Cultural awareness with the ability to think and work, globally
•  Ability to travel as needed for the position

Education:

•  Bachelor’s Degree or other relevant experience required. Life-science, health or industry-related discipline preferred

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Position Purpose:

• The Site Activation Partner is responsible for leading or supporting operational activities from start-up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and Client standards
• Responsibility within a country and may span over more than 1 country depending on the geographical region and business needs

Primary Responsibilities:

Clinical Trial Site Activation

• Initiate and coordinate activities and essential documents management during start-up towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for site initiation
• Register investigator sites and Client stakeholders in Client registries and systems as required. Update and regularly maintain the registry with accuracy and have it inspection ready Work directly and interact with investigator sites to confirm readiness for site start-up by reviewing study site profile ready in Shared Investigator Platform (SIP) or reviewing/completing critical information Sheet inclusive of but not limited to Investigator Initiation Packages (IIP) essential documents components, Site contracts contacts, clinical supply shipment information, payment information, IRB submission and status
• Take the lead to resolve issues or concerns and timely escalation of Site issues where applicable
• Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572/Attestation Form, for internal regulatory approval within required timelines Manage and coordinate with other supporting roles to ensure timely site activation and operational activities
• Support the compilation of the Central Investigator Review Board (IRB) package and submissions to approval of the study (where applicable) and other committees as per country requirements
• Coordinate the timely communication, documentation and responses between Client and Central Ethics committee to bring clinical study to approval (country dependent)
• Support investigators sites with local IRB workflow from preparation, submission through approval
• Assist with preparation, handling and distribution of non-Clinical Trial Supplies and maintenance of tracking information as needed
• Collaborate with the Study Team on the development and readiness of sites electronic Investigator Site File (eISF) when utilized and act as primary point of contact for the sites and manage the Site Operations/CRO monitor access to eISF prior to Site Initiation Visit (SIV)
• Assist with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures
• Support & implement activities in SIP to align with Client strategy as it relates to the role
• Coordinate translation of documents that are within scope with the preferred translation vendors

Clinical Trials Conduct

• Post site activation, initiate and coordinate activities and essential documents management with the investigator’s sites towards the compilation of a high-quality documents and updates through the life cycle of a study such as the documents management for protocol amendments, FDA 1572/Attestation revisions, Ethics Committee annual approvals and other activities required during study conduct
• Ensure maintenance of IRB/Ethics and other committees’ activities as applicable
• Responsible for timely filing of documents to Trial Master File and assisting with periodic quality review of study files for accuracy and completeness
• Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines
• Supports investigator sites, and study teams in preparation for and providing responses to site audits / inspections

Clinical Trial Site Support

• As needed, perform, awareness session with site personnel on Client requirements and to ensure ongoing compliance with study documentation in accordance with prevailing laws, Good Clinical Practices, and Client standards
• Identify and resolve investigator site issues within required timeframes; align with study team and local country colleagues on corrective and preventative actions to close open issues and to prevent recurrence / persistence of issues

General

• Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, system and process related training
• Adhere to EP and Client SOPs and processes
• A good understanding of the Site Activation requirements and processes within the country/region and be able to learn and potentially implement in more than one (1) country

Additional Responsibilities

• May be assigned as Site Activation Partner Point of Contact (PoC) on a study conducted in multi-country
• May be assigned as a Subject Matter Expert (SME) on a system and/or process, and represent the SAP function as applicable
• May represent the SAP role on global initiatives
• Able to act as an SME on projects and initiatives, as requested
• Support the mentoring of new hires on processes/ system

Ability to use and learn systems, and to use independently

•  Microsoft Suite
•  Clinical Trial Management Systems (CTMS)
•  Electronic Trial Master File
•  Electronic Investigator Site File (e.g. Florence)
•  Document exchange portals
•  Shared Investigator Platform
•  Ethics, National Networks and Governing Bodies Portals and platforms (as needed)

The Individual:

• School diploma/certificate with equivalent combination of education, training and experience; Bachelor of Science, Bachelor of Arts or Bachelor’s in Life Sciences preferred
• Minimum 2 years’ relevant experience in clinical site management
• Experience working in the pharmaceutical industry/or CRO in study site activation is preferred
• Knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
• Good technical skills and ability to learn and use multiple systems
• Demonstrated knowledge of clinical research and development processes, Key operational elements of a clinical trial, and ability to gain command of process details
• Understand the quality expectations and emphasis on right first time. Demonstrate compliance with all applicable company, regulatory and country requirements. Attention to detail evident in a disciplined approach
• Ability to work independently and also as a team member
• Ability to organize tasks, time and priorities, ability to multi-task
• Understand basic medical terminology, GCP requirements and proficient in computer operations
• Must be fluent in English