Project Operations Manager - 3 Yrs Contract

PURPOSE OF THE JOB

• Provides project management and study execution leadership in the delivery of clinical studies.
• Serves as the main point of contact for project management between CRU and Sponsor’s cross functional study teams.
• Responsible for cross-functional interactions between CRU and Sponsor study teams.
• Leads and influences cross-functional communications to ensure smooth delivery of clinical studies.

CORE JOB TASK

Project Management and Operational Activity

• Leads communication and liaison in study and operational planning between internal (LCCP) and external (Lilly) cross functional teams to optimise LCCP implementation of Lilly protocols.
• Drives the integration of CRU cross-functional activities to deliver study requirements.
• Provides consistency in study execution in the CRU by:
• ­Serving as Subject Matter Expert and a resource of knowledge for CRU operational processes, local IRB and regulatory requirements, to both internal and external team members.
• Providing input on study design and operational processes during study planning.
• Working with sponsor and site project teams to ensure consistency in responses to IRB.
• Working with Scheduler and protocol lead to ensure development of realistic project milestones and deliverables.
• Provides leadership and operational input to CRU study teams, through participation in various meetings such as protocol review meetings, study execution meetings and liaising with sponsor to resolve emerging study execution issues.
• Maintains deep cross-functional process expertise to ensure consulting advice is current with global and local policies, procedures and best practices.

Communication Management

• Ensures accurate collection and communication of CRU metrics.
• Maintains a database of clinical operational information relevant to the clinical research unit.
• Influences study teams to maintain proper documentation of key decisions, actions and meeting minutes.
• Identify and share learning opportunities or process improvements with teams to improve effectiveness of study execution.
• Participates or lead post study lessons learned to identify strengths and/or areas for improvements and ensure such lessons learned are communicated to all relevant teams.

Leadership

• Demonstrates an ability to work with teams at all levels, working with and delivering through others.
• Demonstrates effective problem-solving skills to influence result-oriented actions.
• Demonstrates strategic thinking and ability to think differently to incorporate new learning.

People Management

• Supervises, coaches and manages team members to effectively deliver results for the clinical research unit.
• Defines individual and functional group objectives in alignment with LCCP priorities and Lilly objectives.
• Manages team members’ performance through the performance review process.

Required Qualifications and Experience

• Degree in science or health-related field.
• Minimum 5 years of experience in clinical research with project management and/or operational management experience.
• Experience in early phase clinical research preferred.

Required Skills

• Ability to communicate with and influence teams cross-culturally and across time zones.
• Excellent interpersonal skills and communication skills.
• Strong problem solving and leadership skills.
• Ability to influence business decisions.
• Understanding of clinical trial processes and the interdependencies of various tasks that require coordination across various functional teams.

Other Information

• Occasional travel (1-2x/year) to the USA may be required.
• Occasional out of office hour conference calls and meetings may be required