Clinical Project Manager Outcome Software, Inc.
THIS JOB HAS EXPIRED uOutcome, the real-world and late phase research company of Quintiles, is the global market leader in patient registries, peri and post-approval studies, data, and integrated technologies for evaluating real-world outcomes. We provide services and technologies focused on evaluating the safety, effectiveness, value, and quality of healthcare products, therapies, and services. Our teams have designed and implemented an industry-leading number of real-world studies including many of the largest and most well-recognized programs for disease outcomes, safety, and risk management.
We currently seek a talented Clinical Project Manager (CPM) to manage the execution of the assigned regionally-based clinical study(ies) per Contract, from initiation through to closeout. He/she will 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
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 with sound judement
Excellent customer service skills along with good presentation skills
Strong software and computer skills, including MS Office
Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's degree in life sciences or related field and 5 years? clinical research experience including 2 years? project management experience and experience in clinical operations; or equivalent combination of education, training and experience.
Primary Location: USA-Massachusetts-Cambridge
Organization: USA02 - US Clinical Development Svcs
||Cambridge, MA |
THIS JOB HAS EXPIRED