Manage the execution of the assignedregionally-based clinical study(ies) per Contract, from initiation through to closeout. Ensure that all clinical study management and project deliverables are completed to the Sponsor's satisfaction, ensuring quality deliverables on time and within budget and in accordance with SOPs, policies and practices.
Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles and ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance.
Serve as primary project contact with Sponsor to ensure communication is maintained and reporting schedules are adhered to.
Collect information on team performance against contract, customer expectations, and project baselines.
Lead problem solving and resolution efforts to include management of risk, contingencies and issues.
Identify quality issues within the study to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties.
Provide input for the development of proposals for new work and manage project budgets.
Provide input to line managers of their project team members' performance relative to project tasks.
Prepare and present project information at internal and external meetings.
Participate in proposal development and in the bid-defense process with guidance and supervision.
Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site/visits and ongoing mentoring of CRA team.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
Good therapeutic and protocol knowledge
Strong communication and interpersonal skills, including good command of English language
Good problem solving skills
Demonstrated ability to deliver results to the appropriate quality and timeline metrics
Good teamwork skills
Excellent customer service skills
Good presentation skills
Strong software and computer skills, including MS Office applications
Ability to establish and maintain effective working relationships with coworkers, managers and clients
Apply on company website