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Clinical Research Manager
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CORE JOB TASK:

Management of clinical operations team.

  • Actively involved in resource planning for assigned clinical operations team.
  • Develop and implement relevant plans, metrics and tracking mechanisms to improve the effectiveness and efficiency of clinical operations and ensure continuous improvement of overall team performance. 
  • Monitor the overall performance of assigned clinical operations team and provide regular reports to line management.
  • Effectively lead, manage, coach, mentor and develop direct reports in clinical operations team.
  • Support the planning and delivery of training programme for clinical operations team to develop technical skills and ensure professional competency.
  • Build strong networks and communicate with other departments within R&G in all relevant areas.

Project management and quality compliance

  • Work closely with project managers to oversee the management of clinical trials to ensure the quality and integrity of data, and safety and efficacy of the investigational product.
  • Provide ongoing support to project managers, and manage day-to-day clinical operations. Ensure compliance with ICH-GCP, applicable local laws, regulations and guidelines, as well as R&G’s SOPs.
  • Provide support to co-monitoring visits when required.
  • Mentor and coach project managers, if needed.
  • Provide support to audit activities conducted internally and externally.

Business Development

  • Serve as account service manager for key clients and work closely with business development department to ensure smooth communication with client and a satisfactory service.
  • Provide technical input to project proposals.
REQUIREMENTS:
  • A Bachelor Degree or above in a medical, health, or science related area.
  • Minimum of 5 years experience in clinical trial management or related areas, and thorough understanding of all relevant guidelines and regulations.
  • Strong leadership and influence skills.
  • Strong people management skills.
  • Strong verbal and written communication skills.
  • Strong interpersonal skills
Location:
Beijing, Shanghai
Lead CRA
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CORE JOB TASK:

Project management

  • Lead project team and act as main contact window for sponsor.
  • Coordinate and supervise all aspects of implementing and conducting clinical studies in accordance with applicable regulations, GCP/ICH guidelines, and applicable SOPs.
  • Contribute to the development of protocols and CRFs.
  • Generate clinical project management plans including timeline projections and monitoring strategies.
  • Be overall responsible for protocol compliance across all sites, and study milestone delivery.
  • Participate in site selection, initiation, monitoring, and closure activities.
  • Prepare and implement project-specific training programs and presentations for internal and external clinical teams.
  • Organise and participate in investigator meetings, including preparation and deliverance of presentations.
  • Provide regular project status reports for both internal and external clients as agreed. 
  • Review CRA visit reports and correspondence. Make recommendations regarding monitoring, safety, eligibility, enrolment, and data consistency, and be involved in issue escalation and resolution.
  • Track and ensure study budgets in accordance with each study agreement..
  • Mentor and coach CRAs and project managers (senior PM only).
  • Conduct co-monitoring visits if needed.
  • Provide input to study proposals and budgets as needed.

Others

  • Act as topic expert for internal process improvement and training.
  • Act as key client contact if needed to ensure smooth and efficient communication and customer satisfaction.
  • Stay abreast with clinical research development, and share important development information including market information which may impact our business presence or plan with internal teams in a timely manner.  
REQUIREMENTS:
  • A Bachelor Degree or above in a medical, health, or science related area, or a nursing degree.
  • Minimum of 3 years related experience in clinical research and project management. Prior project management experience preferred.
  • Thorough understanding of all relevant ICH-GCP guidelines and regulations within covered countries.
  • Good verbal and written communication skills.
  • Team player, self-motivated and with attention to details.
  • Demonstrated leadership, influence and problem-solving skills.
  • Strong interpersonal skills.
  • Must be able to travel.
Location:
Beijing, Shanghai
(Senior) Clinical Research Associate
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CORE JOB TASK:

The role of clinical research associate (CRA) is to identify, evaluate, and manage the initiation and close out of investigator sites for clinical studies. Monitor the sites to ensure studies are conducted in accordance with protocol, study guidelines, ICH-GCP/ISO13485, local regulations and company SOPs.

CRA I & II, Senior CRA

  • Conduct study/site feasibility, recommend and evaluate investigators/study sites.
  • Conduct study preparation, initiation, investigator/site training/meeting, monitoring, and closeout ensuring compliance with applicable protocols, study guidelines, ICH-GCP/ISO13485, local regulations and company SOPs.
  • Coordinate investigational product shipments and product disposition. Provide timely and adequate distribution and return of drug supplies and other study-related supplies.
  • Work with site staff closely to meet target recruitment, standard quality, resolve data queries in a timely manner.
  • Write monitoring visit reports/contact reports, meeting minutes and investigator/site correspondence according to agreed project plan.
  • Maintain study files to ensure completeness and up-to-date of all essential documents in TMF and investigator files.
  • Communicate progress of study and relevant information to Project Manager and other project team members. Assist Project Manager with additional responsibilities as required.
  • Assist in project manager to ensure study budget on track.

Senior CRA

  • Assist in protocol drafting and informed consent and case report forms development and approval
  • Work with project manager to develop training manuals and other study-related documents/tools
  • Mentor and coach junior CRA
  • Conduct co-monitoring as assigned by PM
  • Provide input to study proposal as needed
REQUIREMENTS:
  • A Bachelor Degree in a medical, health, or science related areas.
  • CRA I: Minimum of 1 year related experience in clinical trial management or related areas
  • Senior CRA: Minimum of 3 years related experience in clinical trial management or related areas
  • Good understanding of clinical trial related guidelines and regulations.
  • Good verbal and written communication skills.
  • Good team player, self-motivated and attention to details.
  • Strong customer focused sensitivity towards internal and external customers.
  • Must be able to travel.
Location:
Beijing, Shanghai,Harbin,Changchun,Dalian, Urumchi, Shijiazhuang, Zhengzhou, Xi \\\'an, Qingdao, Ji’nan, Nanjing, Changsha, Wuhan, Chengdu, Hangzhou, Fuzhou
Training Manager
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CORE JOB TASK:

People Development and Management

  •      Ensure appropriate staffing with qualified training specialists/coordinators
  •      Recruit, develop, supervise and support training teams

                    

Training                                  

  • Assess and determine the technical training and development needs of R&G staff
  • Develop company training plans
  • Maintain company and department training plans
  • Design, develop, deliver and/or organize learning events
  • Prepare, track and update training budgets
  • Ensure that learning events for R&G staff at the company level are delivered
  • Promote a learning environment within company where employees assume more responsibility for training and self-study

 

Document Management

  • Ensure training documentation are completed and maintained as per applicable regulations, ICH GCP and company requirements
REQUIREMENTS:
  • Bachelor degree or above in Clinical Medicine/Pharmacy/Biological Sciences or equivalent.
  • Minimum of 5 years experience in clinical research and project management. For senior position, 7 years experience including 3 years in training is minimal.
  • Good understanding of ICH-GCP, China GCP and other applicable regulations.
  • Experience in developing or delivering training programs
  • Strong verbal and written communication skills, and presentation skills
  • Strong influencing and networking skills
  • Competent in verbal and written English
  • Excellent planning and organizational skills
  • Strong analytical skills
  • Demonstrated ability to work in a team environment
  • Strong people management skills preferred 
Location:
Beijing, Shanghai
Training Coordinator
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CORE JOB TASK:

Training

Assist (senior) Training Specialist in the following activities:

  • Deliver relevant training requirements to R&G employees
  • Prepare, track and update training budgets
  • Collect training needs from R&G business departments and assist in designing training courses.
  • Coordinate the logistic arrangement with other functions for off-site/in house training activities, such as training avenue, accommodation, catering, IT etc.
  • Send out invites and follow up with attendees. Summarize trainee’s feedback
  • Coordinate training courses and file training records in Individual Training Files (ITF).
  • Establish and maintain training material repository.
  • Manage and maintain e-learning system at R&G.
  • Deliver soft-skills training if applicable.

 

Document Management

  • Assist in maintaining job description templates and coordinate regular reviews.
  • Assist in setting up and maintaining ITFs for all R&G employees
REQUIREMENTS:
  • Associate Degree or above
  • Good communication and networking skills
  • Experience in organizing team activities.
Location:
Beijing, Shanghai
QA Auditor
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CORE JOB TASK:

QA Activities

  • Plan, schedule and perform internal, client and vendor audits and review as required in order to assure that clinical studies managed by R&G PharmaStudies are of the highest standard and in compliance with the requirements of R&G PharmaStudies or Sponsor SOPs, study protocols and GxP.
  • Evaluate the significance of audit findings and coordinate responses with functional departments and/or study teams.
  • Manage processes for internal non-compliance corrective action plans.
  • Develop audit checklists, plans and agendas of audits for QA internal and external audits.
  • Assist in or host client audits and/or health authority inspections.

Training Activities

  • Provide training to internal staff and/or investigational site staff on regulatory requirements, compliance standards, and quality initiatives in preparation of regulatory inspection.
  • Provide GCP compliance training, audit and inspection readiness training.

Advisory and Supporting

  • Liaise with Clinical Operations, MA, RA, Biometrics, SMO and Pharmacovigilance to assist in interpretation and application of GxP requirements.
  • Provide on-going support to clinical project managers on compliance and quality issues.

 

REQUIREMENTS:

Skills

  • Demonstrated effective balance of quality and speed in complex situations.
  • Demonstrated ability to work in a team environment.
  • Demonstrated ability to work under pressure with minimal supervision.
  • Strong interpersonal and communication skills.
  • Strong analytical skills.
  • Excellent planning and organizational skills.
  • Excellent oral, written and presentation skills.

Education

  • Bachelor degree or above in Clinical Medicine/Pharmacy/Biological Sciences or equivalent.
  • Language Skills
  • Competent in written and oral English.

Work Experience

  • Minimum of 3 years experience in pharmaceutical/medical device industry and preferred having experience in clinical operations and project management. Minimum 1 years working experience in compliance/quality control/quality assurance in GxP areas (mainly GCP). For Senior QA Auditor, 5 years experience including 2 years as a QA Auditor is a minimum. 
  • Thorough knowledge of drug development process.
  • Detailed knowledge of ICH-GCP Guidelines and regulations.
Location:
Beijing, Shanghai
Compliance Specialist
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CORE JOB TASK:
  • Perform co-monitoring/compliance visits in accordance with R&G Yearly Quality Control (QC) plan to assist Business Owner to deliver compliance activities with relevant ICH, GCP, country regulations and guidelines, mentor and coach staff members (e.g. CRA) when applicable.
  • Support Business team in preparing for sponsor audits and provide input into the generation of timely and appropriate audit response plans and assisting in preparation and responses for regulatory authority inspections.
  • Provide compliance support by answering questions or providing advice on GCP, SOPs, regulations and guidelines.
  • Participate in R&G and department system/standards improvement activities.
REQUIREMENTS:
  • A Bachelor Degree or above in a medical, health, or science related area, or a nursing degree.
  • Minimum of 3 years related experience in clinical trial management or related areas including at least 2 years experience in Clinical Operations / Project Management / Medical Affairs / Biometrics. For Senior Compliance Specialist, 5 years experience in clinical trial management including 2 years experience in QC/QA/Compliance as a minimum.
  • Good understanding of Phase I – IV clinical trials quality control principles, clinical monitoring procedures, all relevant GCP guidelines and of local and international regulations.
  • Knowledge of medical terminology and high proficiency in Microsoft Word / Excel / PowerPoint / Outlook.
  • Competent in written and oral English. 
  • Excellent interpersonal, communication and organizational skills.
  • Team player, self-motivated with attention to details.
  • Able to travel when required.
Location:
Beijing, Shanghai
Clinical Research Coordinator
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CORE JOB TASK:

Study Management  

  • Protocol Evaluation
  • Site Preparation
  • Close-Out

Project Activities

  • Investigational Product Accountability
  • Laboratory Issues
  • Adverse Events
  • Responsibilities and Obligations

Subject Coordination

  • Recruitment
  • Informed Consent
  • Screening/Scheduling
  • Study Conduct

Documentation and Administration

  • Case Report Forms (CRFs)
  • Source Documentation
  • Financial/Budgetary Issues
REQUIREMENTS:
  • A Bachelor Degree or above in a medical, health, or science related area, or a nursing degree.
  • Minimum of 1 years related experience in clinical research.
  • Thorough understanding of all relevant ICH-GCP guidelines and regulations.
  • Good verbal and written communication skills.
  • Team player, self-motivated with attention to details.
  • Strong interpersonal skills
  • Must be able to travel.
Location:
Beijing, Shanghai,Nanjing, Tianjin, Zhengzhou, Changsha, Hangzhou, Guangzhou, Xi \'an
BD Manager
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CORE JOB TASK:
  • Execute business development activities and action plans; establish and maintain positive contacts and working relations with existing customers; compose and follow proposal and quotation for specific project
  • Execute business development activities and action plans; generate annual, monthly and weekly plans for different BD positions.
  • Organize and execute marketing activities
  • Generate, negotiate and follow up the contract with sponsor
  • Act as a liaison between all service departments and the clients to achieve balance between the clients’ needs and the services provided
REQUIREMENTS:
  • With medical background
  • 2 years BD experience in CRO industry preferred
  • With abilities such as logical thinking, decision making, communication, planning and execution, and cohesiveness
  • Good knowledge on CRO and GCP preferred
  • Sensitive to client relationship maintenance
  • Positive, passionate, open, self-confident, with patience and conscientiousness, and easy to get along with
Location:
Beijing, Shanghai
Medical Writer Manager
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CORE JOB TASK:
  • To work with sponsor, investigator and statistician, develop concept sheet, synopsis and brief protocol for submission (IND/CTA)
  • To prepare protocol package (develop protocol, ICF, patient dairy etc.; review CRF) for ethical committee submission together with internal and external partners
  • To review analysis plan and analysis report, clinical study report and other high level documents (summary of clinical efficacy and safety, and efficacy and safety updates)
  • To act as documentation consultant in clinical trial teams to ensure compliance of documentation to GCP, SOPs, and external guidelines
  • To act as liaison between clinical trial teams and regulatory team to ensure timely delivery of final documents for submission (NDA)
  • To assure preparation, review, QC and approval of clinical documents.
  • To give professional input to publications prepared by doctors/investigators
REQUIREMENTS:
  • Master Degree or above in life science (clinical medicine is a plus)
  • Around 4 years’ work experience and 2 years of medical writing
  • Fluent verbal and written English (equals to CEF C1,  BEC H, IELTS 7.0) /Japanese
  • Ability to handle multiple tasks simultaneously under pressure
  • Good communication skills and good team player
  • Ability to coach other medical writers (including external writers)
  • Global, cross-cultural perspective and customer orientation
Location:
Beijing, Shanghai
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