Clinical Trial Leader

Trial Preparation

• Accountable for the accurate planning and operational feasibility of trial timelines; and oversight of trial preparation to ensure trial team members are aligned and on track. Supports development of trial level documents owned by other functions (e.g. Statistics, Data Management, Study Physician, Medical Writing, Site Monitoring)

• Verifies and provides input into the country allocation and oversees trial feasibility

• Accountable for development and implementation of trial level engagement plans, recruitment planning and risk mitigation

• Leads development of core trial and patient facing documents

• Integrates patient/site level feedback during document development and ensures trials are designed with a focus on patient value

• Ensures activities are frontloaded where possible at the trial level and cascaded to country level to facilitate efficiencies as well as to ensure and leverage speed

• Oversees outsourcing of vendor services in conjunction with other functions; supports identification of vendors, vendor selection and development of vendor scope of work

• Works with functional partners to ensure that all required trial processes are in place to meet trial delivery milestones (e.g. clinical quality monitoring, safety monitoring and reporting, investigational medicinal product, trial budget, site monitoring)

• Aligns and supports team members in timely responses to questions from Regulatory Authority/Ethics Committee and other external stakeholders

• Provides/supports provision of appropriate study- specific and standardized non-trial specific trial team training, internal and external partners

Trial Conduct

• Maintains oversight during clinical trial conduct including adherence to GCP and all global and local regulatory requirements; compliance with SOPs and continuous risk monitoring/mitigation

• In collaboration with other functions, ensures budget oversight, including support of regular clinical quality monitoring, Safety Management Committee (SMC)/Data Management Committee (DMC) management and safety reporting

• Prepare and implement amendments of core documents including training material updates/retraining as needed

• Support authority/ethics responses to requests as applicable

• Maintains oversight of outsourcing of vendor services (including central lab) in conjunction with other functions

• Monitor progress of patient recruitment and accrual of endpoints and proactively update and action contingencies throughout trial conduct.

• For early clinical trials, co-ordinates and harmonizes Innovation Unit tasks in a trial (e.g. biomarker sampling, genomics, sub-studies)

Trial Closeout and Reporting

• In collaboration with other functions, ensures timely cleaning and delivery of clinical trial data

• Coordinates and supports Trial Medical Writer in providing the Clinical Trial Report (CTR)

• Responsible for timely, complete, and compliant archiving of all relevant global documents in the TMF, including all require documents from vendors.

• Support results/documents disclosure of global registries

• May support publication of trial data

Contributions to Trial Strategy

• Supports preparation and execution of clinical trials, including: (i) planning of trial milestones; (ii) contributing operational and scientific expertise; and iii) considering and planning for regulatory interactions

• Supports Clinical Development and Operations Lead (CDOL) to ensure issues are raised to Client’s Evidence team for timely action or mitigation

• Responsible for the Trial Feasibility activities that define key aspects of a Clinical Trial Protocol (CTP)

Leadership competencies

• Creates an environment that inspires, motivates, and empowers colleagues and promotes client’s Clinical Development and Operations (CD&O) identity, contributing to acceleration of clinical development timelines and value creation for patients

• Fosters a learning culture in client’s CD&O regions by encouraging continuous learning, sharing best practices, and learning from failures

• Embraces innovative technologies, as well as creates and maintains a culture that drives empowerment, smart risk taking and client’s CD&O identity

Compliance with Parexel standards

• Comply with required training curriculum

• Complete timesheets accurately as required

• Submit expense reports as required

• Update CV as required

• Maintain a working knowledge of and comply with Parexel processes, ICHGCPs and other applicable requirements

Skills:

• Strong clinical trial project management experience. In-depth understanding of project management with emphasis on team work to promote high-performance teams

• Experience in Therapeutic Areas relevant in client pipeline is desirable

• Understanding of major regulations (US FDA, EMA and PMDA)

• Familiarity with guidelines and standard of care is desirable

• Cross geographical experience. Working in multi-cultural environment; strong understanding of corporate culture and cross-cultural dynamics

• Strengths in mentoring/coaching

• Demonstrated competencies in Agility, Accountability, and Intrapreneurship: fast decision-making, flexibility, ownership, outcome-based thinking, results orientation, and smart risk-taking

Knowledge and Experience:

• Strong Communication Skills: Articulates and aligns business strategy/plan on an ongoing basis, ensuring alignment between words and action. Demonstrates active listening skills and cultural awareness.

• Scientific and Operational Expertise: Demonstrates scientific and therapeutic knowledge and operational expertise across all aspects of clinical trial planning and execution. Dimensions of trial complexity include protocol, patients, sites, countries, vendors. Extensive experience in clinical trial project management in an international context.

• Leadership and Influence: Demonstrates skills and capabilities in addressing complex situations, confidently setting direction for teams. Demonstrates leadership behaviors of supporting, connecting, and empowering teams, providing future direction, demonstrating visionary and innovative thinking and inspiring teams to achieve a common goal. Executes activities with a clear aim to deliver value to patients.

• Strategic Mindset: Strategic and visionary thinker who is future focused, creative, courageous, and able to navigate through ambiguity. Integrates study strategy with overall TA portfolio. Embraces cross functional initiatives, applying innovative learnings. Is results-oriented with a global mindset using analytical thinking to provide risk-balanced solutions.

• Coordination and Oversight: Collaborative leader who demonstrates skills and capabilities in setting priorities, managing pace of activities, and efficient usage of resources.

• Project Management: Plans effectively, setting priorities, and defining actions. Makes effective use of resources, and proactively strives for transparency and clarity to accomplish the business deliverables. Translates complex situations to actionable parts. Anticipates and resolves challenges and translates learnings to new projects. Takes smart risks.

Education:

• Requires a university degree (e.g. bachelor’s or advanced degree). Major focus: Biomedical Life Sciences.