职位描述
Job Summary
The Senior Study Data Manager I (Sr. SDM I) is responsible for end-to-end quality deliverables of data management activities for clinical trial including study set-up, conduct and close-out, complying with GCP and applicable regulatory guidance. Ensure activities are completed according to agreed standards and timelines
develop and implement data management plans
serve as representative in the study team
provide comprehensive data management expertise and support to team members
coordinate cross functional teams to ensure the flawless conduct of a clinical trial.
Key Accountabilities
-Primary contact between Trial Operations and Clinical Trial Team (CTT). Liaises directly with internal customers (Clinical, Biostatistics, Safety, Quality Assurance, etc.) to negotiate responsibilities and timelines covering all data management activities for assigned study. Ensures CTT are consulted appropriately on study decisions. Proposes solutions for data management issues that arise during the conduct of a study.
-Coordinates internal DM team (Clinical Data Coordinators, Study Data Managers) assigned on the study. Assumes the mentor role for DM team and oversees the quality of data management activities for designated team members.
-In charge of the study deliverables, such as CRFs, Data Management Plan, Data Validation Specification, Study Risk Management Plan, Data Review Listings/Reports as per company standards. Assures that data management standards are followed. Manages study document archiving in eTMF according to eTMF guidance. Participates in Investigator Meetings and other outside meetings if required. Maintains knowledge of current regulations and technologies related to the data management function.
-Participates in the implementation of department initiatives. Implements and oversees processes and coordinates activities in conjunction with the internal team and Team Leader. Continually evaluates DM processes and applications for improvements. Participates in working groups to develop and implement new procedures.
-Manages External customers (CROs) independently on data management activities and maintains a good working relationship with vendor. Reviews vendor proposal and contract for inclusion of appropriate scope of work, pricing and agreed services. Performs assessment of vendor performance trends and service risks. Meets regularly with vendor representative to implement mitigation actions. Obtains appropriate approval for scope of work and budget update. Reviews and approves vendor invoices based on the contract. Ensures all vendor contract related documents are processed on-time.
职位要求：
Education and Qualifications
-Bachelor degree or above
-Preferably in a life science or mathematics-related area (e.g., computer sciences)
-With more than 3 years of Clinical Data Management or equivalent experience in clinical trial industry
Knowledge and Skill Requirements
-Understands the clinical trial development process.
-Knowledge of industry standards and practices.
-Communicates effectively with study team and departmental associates. Establishes rapport and collaborates with both inside and outside the company. Demonstrates flexibility through effective negotiations. Can be direct yet diplomatic.
-Anticipates problems, issues, and delays, and proactively works to minimize the impact. Learn quickly when facing new problems. Use rigorous, objective logic and methods to solve difficult problems with effective solutions.
-Follows through with all tasks and ensures high quality results. Set clear assignments as well as clear objectives and measures. Monitor process, progress and results. Consistently meet deadlines according to accepted levels of quality. Pays attention to details.
-Solid Clinical Data Management System experience (e.g., RAVE, InForm) and understanding of database/programming concepts. Expertise in the usage of Data Management applications and database/file structures. Understands the rationale or able to identify discrepancies by using query languages, such as SQL. Able to acquire and apply new technical skills.
-Autonomously leds multiple complex or less complex studies with limited or without supervision. Works well under pressure. Good team player.
-Vendor management experience and good client facing skills are preferred.
-Good interpersonal and communication skills.
-Strong English skills (both verbal and written).
-Proficiency in Microsoft Office Suite (intermediate level)
