MA OPERATION MANAGER

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.
esponsibility(工作职责) Project Management 1) Set up and lead the project team to ensure the study is implemented according to company policy, SOPs, and relative regulations.
2) Lead the project team to accomplish the proposed timeline.
3) Lead the protocol design and approval process, provide scientific and feasibility input on the protocol and other study documents design 4) Communicate with internal and external customers in terms of project progress and outstanding issues.
5) Prepare study budget proposal based on fair market value and ensure the study is operated according to the budget.
6) Perform co-visit and actively guide/coach team members in the study team and provide the study training as needed.
7) Coordinate with data management, statistician, and medical writer to generate the statistical report and study report.
8) Evaluate the CRO, provide evaluation assessment to line manager.
Site Monitoring and Management, if applicable.
1) Arrange Site/Investigator selection visit to assess the eligibility of the site.
2) Support EC submission and approval before any study activities.
3) Act as primary company contact for assigned study sites, engage with Investigator and sitepersonnel throughout study period.
4) Manage study activities at assigned investigational sites via on-site visits and off-site communication, discuss any issue identified and proper resolution with the site personnel as needed.
5) Discuss the recruitment plan and study timeline with PI and site personnel to get alignment on the targeted goal.
6) Proper training and communication to ensure the study procedure and data collection requirement are well understood.
7) Oversight of site study supplies and drugs/device/biologic supplies to ensure the proper handling, storage and return with accurate inventory and dispense records if applicable.
8) Ensure the data collection and query resolution in a timely manner.
9) Ensure safety events are well documented and timely reported per protocol requirement.
10) Document and archive all study relevant activities; maintain and ensure it is update, complete and accurate and securely stored on site.
11) Provide regular study updates to the project leader and update tracking tools utilized as appropriate.
12) Participate in project team meetings and provides feedback and suggestions for a successful completion of the project.
13) Assist in the preparation for the internal or external audit/inspection and resolve issues cited in audit reports.
14) To take on any other task as assigned by line-manager/project leader.
Vendor Management.
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.
Relationship Building.
1) Build up and maintain healthy relationships with internal and external customers via smooth and efficient communications through the clinical studies.
2) Support the team member to build up and maintain good relationships with study sites and internal customers.
Qualifications 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 – At least 3 years’ experience in study execution, including 1 year experience on project management.
– Able to work effectively with all levels of the organization – People management skill – Fluent in English reading and writing – Skillful at organizing and coordinating – Good time management skill – Good problem-solving skills and initiatives – Good computer skill – Good communication skills – Attention to detail Required Competencies 胜任能力要求 – Refer to SMA Competency Model