Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles to 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 contract 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 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 the CRA team.
Bachelor's Degree Life sciences or related field.
Requires greater than 5 years of prior relevant experience including 2 years project management experience or equivalent combination of education, training and experience.
Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.
therapeutic knowledge desired. Good understanding of the competitive environment and how to communicate / demonstrate value through IQVIA solutions.
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.
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.