Harvest Integrated Research Organization (HiRO) is a globally-oriented, innovative boutique CRO dedicated to elevating cross-border clinical trial pathways. As an emerging global CRO, HiRO collaborates closely with biotech and pharmaceutical companies, aiming to efficiently bridge the gap between laboratory research and market commercialization. Our Team Members are curious and determined, always looking to transform challenges into opportunities. Our mission is to provide cutting-edge and capital-efficient solutions, ultimately benefiting patients worldwide.
Job Title:
[Clinical Project Manager]
Location:
[Shanghai/Beijing]
Job Summary:
Manage the execution of the assigned multi-regional study(ies), which may
include study management, clinical and other functions per Contract, from
initiation through to closeout. Ensure that all 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.
Key Responsibilities:
- 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.
2.Serve as primary project contact with Sponsor to ensure communication is
maintained and continuously improved and reporting schedules are adhered
to.
3.Define, develop and implement study management plans, together with team
assignments and accountabilities.
4.Supervise team performance against contract, customer expectations, and
project baselines. Develop recommendations for issue resolution for
management and Sponsors.
5.risk, contingencies, and issues. Take accountability for proactive contingency
plans to mitigate clinical risk.
6.Identify quality issues within the study through regular review of site
communications, monitoring visit reports, data flow information and quality
assurance audit findings and own the implementation of appropriate
corrective action plans. Manage and oversee the escalation of findings and
action plans to appropriate parties.
7.Collaborate with other functional groups within the company to support
milestone achievement and to manage study issues and obstacles. Ensure that Sponsor feedback is communicated and conveyed to other functional
groups and action is initiated to address.
8.Participate in proposal development, influence the scope and budget
development of proposals for new work, including the study management
costs. Escalate out of scope requests to management.
9.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 Project
Managers.
10.Prepare and present project information at internal and external meetings.
Lead bid defense presentations in partnership with Business Development
and cross-functional staff.
11.Responsible and manage the project P&L statement in a way that delivers
the targets defined.
Preferred experiences and skills:
- 3years clinical research experience including 4 years project management
experience or equivalent combination of education, training, and experience.
- Requires deep knowledge of one or more related job areas typically
obtained through advanced education combined with experience. Typically
viewed as having a specialty within discipline
- Excellent communication and interpersonal skills
- Competent in written and oral English and local language