SENIOR MA STUDY SPECIALIST

Principal Duties and Responsibilities (General Summary, essential functions and authorities, etc.)主要工作职责（基本概况，主要功能，权限等） General Summary（基本概况） The overall purpose of the position is to – Ensure clinical studies or MA related projects to be conducted in compliance with ICH GCP/SOPs, local regulations, and protocols.
– May work as a ‘project leader’ on appropriate projects.
– Develop and maintain working relationships with others requiring interaction and mutual support.
– Provide guidance and coaching to less experienced study specialists and assist in their development and training.
Responsibility(工作职责) Site Monitoring and Management.
1) Be responsible to work on the assigned study sites throughout the study period from site selection to site close out.
2) Act as primary company contact to perform regular monitoring visits to oversee the study progress and discuss any issue identified and proper resolution with the site personnel as needed.
3) Proper training and communication to ensure the study procedure and data collection requirement are well understood.
4) Ensure the data collection and query resolution in a timely manner.
5) Ensure safety events are well documented and timely reported per protocol requirement.
6) Document and archive all study relevant activities; maintain and ensure it is update, complete and accurate and securely stored on site.
7) Provide regular study updates to the project leader and update tracking tools utilized as appropriate.
8) Participate in project team meetings and provides feedback and suggestions for a successful completion of the project.
9) Assist in the preparation for the internal or external audit/inspection.
Resolve issues cited in audit reports.
Project Management, if applicable.
1) Set up and lead the project team to accomplish the studies within time and budget and ensure the compliance.
2) Communicate with internal and external customers in terms of project progress and outstanding issues.
3) Work with MA colleagues on study materials development such as protocol, CRF, ICF and etc.
4) Perform co-monitoring and actively guide/coach team members in the study team and provide the study training as needed.
5) Coordinate with data management, statistician, and medical writer to generate the statistical report and study report.
Vendor Management, if applicable.
1) Perform vendor selection and continuous quality and compliance tracking and evaluation.
2) Perform effective vendor management to ensure the services vendor provided are satisfied and qualified in compliance with J&J policy, SOPs, and other related requirements Other operational support on MA activities 1) Take the role of the local Investigator Initiated Study (IIS) coordinator, assist MA BP in collecting the investigator's IIS proposals, coordinate and track the progress.
Set up Investigational Site File according to SOP and project specific requirement etc.
2) Lead the operational process for Evidence Based Medicine training (EBM), Educational Grant (EG), Research Grant (RG), and other assigned MA projects to apply and execute the projects on request, on time and ensure the process and result fully comply with company policy.
3) Lead the coordination among SMA, HCC, finance, and legal departments, including but not limited to trainings, meetings, contracts discussion, FMV evaluation, budget planning, payment, cross charge etc.
4) Take on any other task as assigned by line-manager/project leader Qualifications 基本任职资格（包括教育背景和/或知识和/或培训和/或相关工作经验） Personal Requirements (include experience, knowledge，skills and education) 个人背景要求 （包括经验，知识，技能和教育背景） – At least with bachelor’s degree of medicine/pharmacy/other healthcare disciplines – Excellent knowledge of applicable local and global SOP and local regulations – 1-2 years’ experience in study execution – Good problem-solving skills and initiatives – Skillful at organizing and coordinating – Able to work effectively with all levels of the organization – Fluent in English reading and writing – Good time management skill – Good computer skill – Good communication skills – Attention to detail Required Competencies 胜任能力要求 – Refer to SMA Competency Model