职位名称 | 职位描述 |
Site Executive, GCTO (CRA) | Position Overview
• Acts as primary site contact and site manager for all operational and routine protocol issues in support of clinical research studies. Communicates with sites on issues related to protocol conduct, enrollment/retention, protocol deviations, regulatory documentation, site audits/inspections, overall site performance, and financial payments.
• Performs on-site monitoring visits, ensuring site compliance with protocol, ICH, GCP global standards, local laws and regulations, including but not limited to review of informed consent, AE/SAEs, Health Authority documentation, and IMP supplies. Performs source document verification of subject data and query resolution. Coordinate receipt and distribution of clinical trial supplies.
• Provides input to Site Selection utilizing site evaluation and validation processes.
• Maintains accurate study site information in the CTMS and records visit and non-visit contacts appropriately and in a timely manner. Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
• Manages a full complement of sites with multiple protocols, depending on study/site complexity. Discusses the need for escalation of site performance issues with CRM, and supports audit/inspection activities as needed.
Requirements
• Medical qualifications, bachelor's degree or above in Clinical Medicine, Pharmacology and Public Health, etc., strong emphasis in science
• Work with high quality and compliance mind-set
• Proficiency in computer skills
• Result oriented
• Teamwork spirit and cooperation skills
• Customer focus
• Good communication skill
• Proactive and self-motivated |
Finance Clinical Trial Coordinator, GCTO | This role is responsible for comprehensive trial and site administration. Under the oversight of the Senior COM or COMs or CTC Manager, the person prepares, collates, distributes and archives clinical documents.
The role is critical to meet planned Site Ready dates. The role will collaborate at local level closely with COM, CRM and CRA. And the person collaborates with finance/budgeting representatives to manage CTRAs and payments.
Responsibilities include, but are not limited to:
• Document management:
o Prepare documents and correspondence
o Collate, distribute/ship, and archive clinical documents, e.g. eTMF
o Assist with eTMF reconciliation
o Update manuals/documents
o Obtain translations of documents
• Site Start-Up responsibilities:
Collaborate with other country roles to:
o Obtain, track and update study insurance certificates
• Budgeting, Agreement and Payments:
Collaborate with finance/budgeting representatives for:
o Develop, control, update and close-out country and site budgets (including Split site budget)
o Develop, negotiate, approve and maintain contracts (e.g. CTRAs)
o Track and report contract negotiations
o Update and maintain contract templates (in cooperation with Legal Department)
o Calculate and execute payments (to investigators, vendors, grants)
o Ensure adherence to financial and compliance procedures
o Monitor and track adherence and disclosures
o Maintain tracking tools
o Obtain and process FCPA documentation in a timely manner
CORE Competency Expectations:
• Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines
• Hands on knowledge of Good Documentation Practices
• Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills required.
• ICH-GCP Knowledge appropriate to role
• Excellent negotiation skills for CTCs in finance area
Behavioural Competency Expectations:
• Effective time management, organizational and interpersonal skills, conflict management
• Effective communication with external customers (e.g. sites and investigators)
• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment
• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
• Demonstrates commitment to Customer focus, both internally and externally.
• Able to work independently
• Proactive attitude to solving problems / proposing solutions
• Positive mindset, growth mindset, capable of working independently with assigned tasks
• Contributes to CTC team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required
Educational Requirements:
• Completed job training (office management, administration, finance, health care preferred) or B.A./B.S. (Life Science preferred) or equivalent healthcare experience. |
Regulatory Clinical Trial Coordinator, GCTO | This role is responsible for comprehensive trial and site administration. Under the oversight of the Senior COM or COMs or CTA Manager, the person prepares, collates, distributes and archives clinical documents.
The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable.
The role is critical to meet planned Site Ready dates, including assisting with the preparation of submission packages to IRB/ERC and Health Authorities. The role will collaborate at local level closely with COM, CRM and CRA. And the person collaborates with finance/budgeting representatives to Support CTRAs payments tracking.
Responsibilities include, but are not limited to:
· Trial and site administration:
- Track (e.g. essential documents) and report (e.g. Safety Reports)
- Ensure collation and distribution of study tools and documents
- Update clinical trial databases (CTMS) and trackers
- Clinical supply & non-clinical supply management, in collaboration with other country roles
- Manage Labeling requirements and coordinate/sign translation change request
· Document management:
- Prepare documents and correspondence
- Collate, distribute/ship, and archive clinical documents, e.g. eTMF
- Assist with eTMF reconciliation
- Execute eTMF Quality Control Plan
- Update manuals/documents (e.g., patient diaries, instructions)
- Document proper destruction of clinical supplies.
- Prepare Investigator trial file binders
- Obtain translations of documents
· Regulatory & Site Start-Up responsibilities:
Collaborate with other country roles to:
- In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
- Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.
- Publish study results for GCTO and RA where required per local legislation
· Budgeting, Agreement and Payments:
Collaborate with finance/budgeting representatives for:
- Monitor and track adherence and disclosures
- Maintain tracking tools
Meeting Planning:
- Organize meetings (create & track study memos/letters/protocols)
- Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)
CORE Competency Expectations:
· Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills
· Hands on knowledge of Good Documentation Practices
· Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills required.
· ICH-GCP Knowledge appropriate to role
· Excellent negotiation skills for CTCs in finance area
Behavioural Competency Expectations:
· Effective time management, organizational and interpersonal skills, conflict management
· Effective communication skill
· High sense of accountability and collaboration. Ability to set priorities and handle multiple tasks simultaneously in a changing environment
· Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
· Demonstrates commitment to Customer focus, both internally and externally.
· Able to work independently after internship
· Proactive attitude to solving problems / proposing solutions
· Positive mindset, growth mindset, capable of working independently with assigned tasks
Educational Requirements:
· Completed job training (office management, administration, finance, health care, supply chain preferred) or B.A./B.S. (Life Science/Pharmacy/Supply Chain preferred) or equivalent healthcare experience. |
IT Emerging Talent Rotation ( ETR ) Program ( IT管培 ) | Our 2-year programme where graduates rotate and experience 3 diverse areas (8 months in each area within IT). You’ll get exciting opportunities that partner you with a buddy, a coach, and an executive supervisor to help develop your skills in tech, business, and leadership and understand how each of these critical areas adds value to and impacts the organization.
• Full-time, entry level opportunity
• 3 IT-related roles in 2 years
• Each time you rotate, your skillsets projects and development goals are aligned with business needs
• Extensive developmental activities
• You will be part of wide global ETR community
• Puts you into the right IT role upon successful completion |
Clinical Data Manager | Brief Description of Position
Primary activities include, but are not limited to:
1、Receives the study related paper documents from sites or other functional areas, registers them into a work management tool and transfers to data enterer for processing.
2、Performs Sponsor Data Entry as applicable per data management plans following entry guidelines.
3、Participates in the development and change request implementation of data management tools and systems for the clinical trial data management activities under the direction of the Senior/Lead Clinical Data Manager.
4、Runs data integrity check reports in accordance with data review plans and relevant SOPs.
5、Raises questions to investigational site staff and internal and external vendors,reviews responses and corresponding data corrections to confirm identified issue resolution.
6、Responsible for the execution of user acceptance testing of data management tools under the guidance of the Senior/Lead Clinical Data Manager.
7、Escalates overdue items, including but not limited to outstanding questions and missing visits.
8、Assists the Senior/Lead Clinical Data Manager with data management activities to resolve all identified data issues prior to study database lock.
9、Complete trial level archiving activities under the direction of the Senior/Lead Clinical Data Manager including, but not limited to, filing of essential documentation.
10、Maintains compliance with standard key performance indicators according to process expectations at the protocol level.
11、Monitors data quality and cycle-time performance measures to maintain compliance,performs root cause analysis and implements action plans as needed.
12、Proactively communicates with Senior/Lead Clinical Data Manager to share project status, risk assessment and outstanding item resolution status.
Qualifications,Skills & Experience
Education:
At least B.A. or B.S. degree, preferably in Medicine, Pharmacy, Nursing, Biological Sciences, or health care related discipline.
Knowledge and Skills:
1. Self-motivated, excellent in work planning and time management.
2. Fluent oral and written English skills.
3. Good sense and awareness of regulations and policies.
4. Able to work under pressure and in a changing environment with flexibility.
5. Good communication skills with the ability to communicate with both the technical and business areas. |
