Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage studyissues and obstacles and ensure consistent use of study tools and training materials and compliance with standardprocesses, policies and procedures.

Develop study management plans, together with team assignments and accountabilities and oversight of databasemaintenance.

Serve as primary project contact with Sponsor to ensure communication is maintained and reporting schedules areadhered 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 actionplans 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/accompaniedsite/visits and ongoing mentoring of CRA team.


In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good ClinicalPractice (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

Good judgment

Strong software and computer skills, including MS Office applications

Ability to establish and maintain effective working relationships with coworkers, managers and clients

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