DUTIES & RESPONSIBILITES
1. Forecast timelines, budget & FTE resource
2. Take a key leadership role in the management of studies’ timeline, quality, cost.
3. Ensures all activities (including HGR activities)must be in compliance with SOPs, applicable policies, and related standards, and in line withGxP, local laws and regulations.
4. Monthly track and manage the agreed studies’timelines, budget, and resource, highlight significant variance and take appropriate actions to get studies on track.
5. Update study information into VCV, Evidence Connect system, Medical Tracking system, and update to global & regional team to ensure up-todate information captured.
6.Review and approve project relevant documents.
7.Lead preparation and delivery of study documents (e.g.Protocols/amendments, ICF,CRF, studies’ related plans and forms, etc.)
8. Prepare and lead investigator and monitor
meeting.
9. Ensure AEs/SAE reporting according to GCP and regulation.
10. Plan and lead activities associated with study level Quality Control plan.
11. Develop & manage contingency risk plans to assure timely delivery to quality, budget, and time and escalate issues to stakeholders as
appropriate.
Job requirements
1.10 years’ experience in clinical research studies/programs in a pharmaceutical company or CRO setting.
2. About 5 years of global project management experience.
3. Clinical research experience in multinational pharmaceutical company.
4. Experience of collaborating with global team and cross functional team.
5. Bachelor or higher degree in Science, Medical or Pharmaceutical Background
6. Leadership Skills as the leader role of project team. Strong interpersonal skills, with the ability to work effectively with others at all levels of the organization. Good communication: be able to
convey information clearly and accurately. Strong interpersonal skills with the ability to work effectively with others at all levels of the organization
7. Learning agility: swiftly acquire new knowledge and skills and apply effectively in practical works.
8. Presentation skills: confidently and fluently delivering project introductions, progress reports,and outcome demonstrations. Proven ability to deliver training
9. 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. Inspires team through impactful and compelling communications.