Clinical Trial Manager

Description

• 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

Qualifications

• 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 focus in Biomedical Life Sciences.