Clinical Project (Operation) Manager --- Local Delivery Unit (Shanghai/Beijing) - (1627068) in Beijing, CN at IQVIA™

Date Posted: 5/11/2018

Job Snapshot

Job Description

Join us on our exciting journey!

IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.
IQVIA™ pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster.
 
 If that is your passion, we have a place for you.
 
PURPOSE 
  • Manage the execution of the assigned clinical study(ies) per Contract, from start-up through to closeout. Meanwhile, manage the human, material, system and fiscal resources to provide clinical monitoring services and ensure clinical staff (CTAs, CRAs and/or CRSs) gain the necessary skills to perform their respective job responsibilities.     
  • 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.
     
RESPONSIBILITIES 
  • 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.
  • Manage clinical staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems.  Approve actions on human resources matters. 
  • Manage their project team members’ performance relative to project tasks. Ensure high performance and efficiency of the clinical team through the scheduling of co monitoring/accompanied site/visits and ongoing mentoring of CRA team.
  • Participate in the selection and onboarding process for new clinical staff by conducting candidate review and participating in the interviewing process. Conduct onboarding training for new staff in conjunction with Human Resources and Learning and Development training programs. 
  • Ensure that staff has the proper materials, systems access and training to complete job responsibilities.  Provide oversight for the execution of the training plan, SOP review and mentored training experiences, as applicable.    
  •  Identify quality issues within the study to implement appropriate corrective action plans to prevent or correct deficiencies in performance of staff.  Escalate findings and action plans to appropriate parties.
  • 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
    adhered to.
  • Lead problem solving and resolution efforts to include management of risk, contingencies and issues.
  • Allocate resources to clinical studies that are appropriate to their experience and training. 
  • Ensures that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management.   Collect information on team performance against contract, customer expectations, and project baselines.
  • Prepare and present project information at internal and external meetings.
  • Participate in proposal development and in the bid-defense process with guidance and supervision.
  • Provide input for the development of proposals for new work and manage project budgets.
  • May participate in clinical operations quality or process initiatives. 
All responsibilities are essential to job functions unless noted as non-essential (N). 

Job Requirements

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES 
  • In depth knowledge of, and ability&skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
  • Strong leadership with excellent organizational and problem solving skills 
  • Good therapeutic and protocol knowledge
  • Excellent customer service skills. Ability to establish and maintain effective working relationships with coworkers, managers and clients
  • Effective time management skills and ability to manage competing priorities.           
  • Demonstrated ability to deliver results to the appropriate quality and timeline metrics
  • Strong communication and interpersonal skills, including good command of English language.
  • Good teamwork skills
  • Good presentation skills
  • Good judgment
  • Strong software and computer skills, including MS Office applications
     
MINIMUM REQUIRED EDUCATION AND EXPERIENCE 
 Bachelor's degree in a health care or other scientific discipline or educational equivalent;
7 yrs of clinical trials experience including 3 years experience in project management;  or equivalent combination of education, training and experience.
We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.

Whatever your career goals, we are here to ensure you get there!

We invite you to join IQVIA™.

Job ID: 1627068