该职位来源于猎聘 职责描述:
- Take a key leadership role in the management of study timeline, quality and cost and must be in compliance with GxP and other applicable policies
- Monthly track and manage the agreed project timelines, budget and resource, highlight significant variance and take appropriate actions to get project on track
- Review and approve project relevant document
- Timely update projects information to the Brand Team
- Lead preparation and delivery of study documents (e.g. Protocols/amendments, ICF, CRF, study related forms, etc.)
- Prepare and lead investigator and monitor meeting
- Ensure AEs/SAE reporting according to GCP and regulation
- Plan and lead activities associated with study level
Quality Control plan
- Develop & manage contingency risk plans to assure timely delivery to quality, budget, and time and escalate issues to stakeholders as appropriate
- Provide operational support to the ESR investigators to ensure the on time delivery of ESR
- Update study information into IMPACT,ESR and/or global & regional team to ensure up-to-date information captured
- Provide input to local process on clinical studies
- Share best practice within team
- Work with Brand Team on KEE/potential investigators development activities including appropriate investigators and sites selection, operational experience improvement through projects delivery in big city big hospital. 任职要求:
- Advanced level monitoring skill, including experience of study start up, ongoing phase and study close down.
- Full understanding of GCP. Familiar with company SOPs. Good Project Leadership and management skill. Good people leadership skills. Able to establish and maintain excellent relationships and partnerships with investigator site staff and study team members. Knowledge of regulatory requirements related to study management activities.
- Good understanding of the data management process and impact of different data management tools on the study management process. Proven abilities as a team leader and team player. Proven ability to coordinate and gain commitment from cross-functional teams
- Commercially Minded: Under the needs of a range of customers such as medics, markets, sales people and patients. Thinks in terms of how to add value to a brand and how to identify commercial benefits to suggested action.
- Build relationship: Creates good impressions with people and proactively builds a network of key contacts (internal and external). Knows who is important and has good relationship with those people. Builds trust quickly, listen to other's points and can talk easily to people from a wide range of backgrounds.
- Academic / Professional qualification / 学 历 / 专 业 资 格
- Bachelor or higher degree in Science, Medical or Pharmaceutical Background
- Technical / skill training / 技 术 / 技 能 训 练
- Strong interpersonal skills, with the ability to work effectively with others at all levels of the organization
- Excellent process, SOP,
GCP and company policy competency
- Strong presentation skills
- Proven ability to deliver training
- Working experience (No. of years / 年 资, Job function / 工 作 功 能, Business types / 业 务 种 类 )
Essential
必 需
- Minimum of 5 years' experience in managing clinical research studies/ programs in a pharmaceutical company or CRO setting. 2-3 years of project management experience.
Desirable
理 想
- Prior experience not only as a clinical management staff, but responsible for training/ quality assurance
- quality control/ procedural document development
- Experience in working in international and cross functional teams
- Language ability / 语 言 能 力
- Good English reading, writing, speaking & listening