KEY ACCOUNTABILITIES:

Trial Preparation

• Accountable for the trial activities for responsible R/OPU, including but not limited to;
• Verify the trial is conducted in compliance with GCP-ICH, local/global regulations, application SOPs and according to the trial protocol by overseeing CRO and internal team activities.
• Creation, management and review of the R/OPU trial budget to verify appropriate level of financial oversight and planning accuracy. Timely budget updates based on trial changes.
• Appropriate trial-specific training of R/OPU internal and external partners is performed in line with trial training plan.
• Accurate planning and co-ordination of operational feasibility of trial timelines for their R/OPU; and oversight of trial preparation to verify trial team members are aligned and on track.
• Verifies and provides input into the country and site level feasibility and OPU commitment. Finalize and validate site selection using available data sources and local insights/expertise, in collaboration with other functions.
• Development and implementation of country level engagement plans, recruitment planning and risk mitigation. Co-ordinates development of country level patient facing documents in close collaboration with relevant internal and external stakeholders. Reports patient and site level feedback as strategic insight to contribute to improving trial design with a focus on patient value.
• Frontloading of activities where possible at the R/OPU level to facilitate efficiencies as well as to verify and leverage speed.
• Oversees outsourcing of vendor services in the R/OPU in accordance to operating models and governance.
• Verify timely responses to questions from Regulatory Authority/Ethic Committee and other external stakeholders

Trial Conduct

• Maintains oversights 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, verifies budget oversight, including support of regular clinical quality monitoring, and safety reporting.
• Monitor progress of patient recruitment endpoints and proactively update and action contingencies throughout trial conduct.
• Support CTL during investigator meetings
• Establish and maintain relationships with external experts, investigational sites, patient organizations and other stakeholders by coordinating and ensuring cross-functional collaboration amongst Clinical Development & Operations (CD&O) ad appropriate functions.
• Active participation in the CD&O community with a special focus on participating in the CTM network, to actively contribute to functional excellence.

Trial Closeout and Reporting

• Verifies timely cleaning and delivery of clinical trial data.
• Responsible for timely, complete and compliant archiving of all relevant R/OPU documents in the TMF, including all required documents from vendors.
• Verifies timely submission of the Clinical Trial Report (CTR) to Regulatory authority/Ethics Committee and other external stakeholders as required by local regulations
• Shares information on trial results with Investigational sites and, if applicable, patients

General Accountabilities

• Build and maintain engagement with Investigators, other site staff and patient organizations (POs), in collaboration with other functions, to verify trial speed and effective start up, conduct and close out.
• Establish and maintain relationships with external experts, investigational sites, patient organizations and other stakeholders by coordinating and ensuring cross-functional collaboration amongst CD&O and appropriate functions.
• Supports CTL to verify issues are raised to Evidence team for timely action or mitigation

Leadership competencies

• Creates an environment that inspires, motivates, and empowers colleagues and promotes one common Clinical Development and Operations (CD&O) identity, contributing to acceleration of clinical development timelines and value creation for patients.
• Fosters a learning culture in 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 one common 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 local/regional major regulations
• Familiarity with guidelines and standard of care is desirable
• Experienced in working with CROs and POs is desirable
• Ability to build and maintain strong relationships of mutual value
• Excellent influencing and communication skills

KNOWLEDGE AND EXPERIENCE:

• Strong Communication Skills: Demonstrates AAI approach and skills in complex cross- functional matrix structures of the trial and extended team. 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.
• Leadership and Influence: Demonstrates skills and capabilities in addressing complex situations, confidently setting direction for teams. Demonstrates leadership behaviours 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:

• University degree (e.g. Masters degree or comparable degree), with several years relevant experience in required area, major f