- Leading and ensuring all data management activities on multiple trials and oversee data management work performed by third parties
- Proactively manages project quality through supervision and Quality control of team member¡¯s work.- Proactively coordinates and performs start-up, processing and finalization activities as listed in the SOPs.- Participate in the review of clinical research documents(e.g. protocols, Case Report Forms, reports and statistical analysis)- Lead study setup including CRF design, DB design/validation, User Acceptance Testing, document creation, etc.- Lead study conduct including Data validation, Medical Coding, Non-CRF handling, etc. as written in the contract.- Lead study closeout including DB Lock, Data transfer, etc.- Successfully deliver Data Management deliverables in accordance with internal and external company requirements.- Project budget awareness and proactive management of timelines and projections- Proactive participation in appropriate Sponsor/project team meetings.- Active involvement in departmental and organizational meetings and initiatives.- Participates in the review of cross functional department procedures.- Communicate with cross functional groups throughout the project lifecycle.- Monitor project scope.- Review, revise and/or develop Data Management Process related SOP, WI, etc.- Training and Mentoring of team members in accordance with established departmental procedures.
- Minimum of 8 years of experience and or demonstrated aptitude for date management work.
- Experience working in CRO industry preferred.
- Working knowledge of EDC studies
- Technology proficiency including Data management systems.
- Strong interpersonal skills and people manage skills
- Study documentation production and maintenance, data processing, data review
- Strong computer skills, including Microsoft office(SQL. SAS preferable)
- Able to exercise judgment within defined procedures and practices and to determine
- Good problem-solving skills
- Demonstrated communication skill in business English, both oral and written
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