At Quintiles we help healthcare and biopharma companies improve their probability of success. We do this by connecting our scientific, therapeutic and analytics expertise with superior delivery. From advisory through operations, Quintiles and its affiliate companies is the world’s largest provider of product development and integrated healthcare services.
As one of FORTUNE’s ‘Most Admired Companies’ in 2016, we offer great opportunities for a career in world-leading clinical research. Our global projects, innovative tools and industry leading customers combined with outstanding support from our leadership team and clear career mapping allows you to make a difference in patient health.
Clinical Project Management is focused on project productivity, delivery and quality resulting in strong financial performance and customer satisfaction. Focus is on demonstrating Real World Evidence expertise to drive operational excellence and strategic leadership with our customers. Leadership of the project team (and/or sub-team) and responsible for achieving project’s overall objectives to the Sponsor’s happiness.
Can you commit to the development of delivery strategy for RFPs? Would you like to participate in bid defense preparations? Are you happy to lead bid defense presentations in partnership with Business Development for multiple service, multiple country and/or region studies?
Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles. Ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures. Implement continuous improvement activities for assigned projects.
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 continuously improved and reporting schedules are adhered to.
Report on team performance against contract, customer expectations, and project baselines to management.
Lead problem solving and resolution efforts to include management of risk, contingencies and issues. Develop proactive contingency plans to mitigate clinical risk.
Identify quality issues within the study through regular review of site communications, monitoring visit reports, data flow information and quality assurance audit findings to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties.
Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
Provide input for the development of proposals for new work and project budgets.
Provide input to line managers of their project team members’ performance relative to project tasks. Recommend team members’ further professional development. Support staff development. Mentor less experienced CPMs.
Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site visits and ongoing mentoring of CRA team.
Prepare and present project information at internal and external meetings.
Participate in proposal development. May lead bid defense presentations in partnership with Business Development and Senior Clinical Project Management staff.
Define project workloads and assignments. Develop and oversee maintenance of internal databases and project plans
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 Harmonization (ICH) guidelines
In depth therapeutic and protocol knowledge
Strong communication and interpersonal skills, including good command of English language
Strong organizational and problem solving skills
Demonstrated ability to deliver results to the appropriate quality and timeline metrics
Good team leadership skills
Effective mentoring and training skills
Excellent customer service skills
Effective presentation skills
Ability to manage competing priorities
Strong software and computer skills, including MS Office applications
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 7 years’ clinical research experience including 4 years’ project management experience and experience in clinical operations; or equivalent combination of education, training and experience.
Extensive use of keyboard requiring repetitive motion of fingers.
Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
Regular sitting for extended periods of time.
May require occasional travel.
Click on the apply link which will take you to this vacancy on the Quintiles careers website and complete your application online
Did You Know?
* Quintiles helped develop or commercialize 98 of the Top 100 best-selling products of 2015
* Quintiles has 36,000 employees conducting business in more than 100 countries
* Quintiles was named to FORTUNE’s World’s Most Admired Companies® 2016 list
* Quintiles was named as a 2016 World’s Most Ethical Company® by the Ethisphere Institute
Primary Location: Hungary
Other Locations: Croatia, Czech Republic, Austria, Bulgaria, Poland, Romania, Latvia, Lithuania, Estonia, Greece, Ukraine, Slovakia, Turkey, Russian Federation, Serbia
Organization: HUN02 - Hungary Product Development
Job: Clinical Project Management