1.To ensure all related clinical research operations and procedures are in compliance with protocol, Reistone’s SOPs, ICH-GCP/Chinese GCP and applicable local regulations.
2.To be responsible for clinical study sites selection and to ensure these sites can meet the Reistone’s requirements and qualified with NMPA.
3.To be responsible for clinical trial start-up at sites, include complete GCP submission, obtain the EC approval, and support for the OHGRA application and approval, contract negotiations and sign-off.
4.To be responsible for initiating, monitoring and closing the clinical study sites and submit the visit reports on time.
5.To be responsible for submitting documents to site GCP office & EC correctly and on time.
6.To ensure storage, distribution, return IMP/NIMP at the sites and report of deviations in compliance with protocol, Reistone’s SOPs, ICH-GCP/Chinese GCP and applicable local regulations.
7.To ensure AEs/SAEs are recorded correctly and reported appropriately according to timeline stipulated in clinical study protocols and current regulation.
8.To ensure the study sites update and maintain essential documents in Investigator Site Files correctly and on time.
9.To be responsible for transfer Reistone study essential documents to TMF on time and consist with ISF.
10.To build and keep good working relationship with clinical study sites.
11.To be able to complete the above tasks under the help and supervision from senior team members with satisfaction.
Role Related Qualifications/ Skills:
1.1-3 year of CRA experience previously.
2.Bachelor’s degree or above in Medical, Pharmacy or related areas.
3.Be familiar with ICH-GCP/Chinese GCP and applicable local regulations.
4.With good communication skills and is expected to establish good relationship with the Investigators and other related site staffs.
5.Good written, verbal skills, and presentation skills in both Chinese and English.
Working location: Shanghai /Beijing
1.To prepare a clinical trial plan including all elements listed in the clinical trial plan template as appropriate for the clinical trial (Time Schedule, Budget, Recruitment Plan, Roles and Responsibilities, Work Breakdown Structure, Management Service Provider, Communication Plan, Risk Management Plan, etc.).
2.Accountable to drive and monitor protocol related activities throughout the lifecycle of the project ensuring targets are met according to timelines, budget and quality expectations.
3.Provides clinical, scientific and operational input into concept sheets and protocol (rational, objectives, design), Case Report Form, and other key protocol/program documents and activities.
4.Leads multiple cross-functional trial teams through start-up activities including study/site budgets and contracts, global geographic deployment (country/site identification, feasibility, selection), and country/site protocol approvals (MOH, IRB/EC) to study conduct, analysis and reporting.
5.Acts as a central point of contact for communication between the team and the external partners, developing mitigation and resolution strategies, and promptly responding to action items
6.Drives oversight of CROs and vendor management at trial level according to the applicable partnership model
7.To be responsible for arranging and preparing of Advisory Board Meeting and Investigator Meeting.
8.To be responsible for the co-ordination of timely trial supplies with IMP department.
9.To be responsible for initialing, monitoring and closing the clinical study sites and ensure that the clinical trial progress according to quality standards, Reistone’s SOPs, ICH-GCP and/or other guidelines to fulfill local regulations.
10.Perform co-monitoring visits, if appropriate.
11.To be responsible for public disclosure of clinical trial according to the Reistone’s SOPs.
12.Ensure the quality of the data.
13.Maintain appropriately and safely all necessary documents in Trial Master Files.
14.To be responsible for working to coordinate for audits and take responsibility for the responses and corrective actions to audit finding.
15.Provides training and coaching to CRAs with regard to all aspects of the clinical trial process.
1.Education: Bachelor’s degree or above in Medical, Pharmacy or related areas.
2.Languages: Fluent English (oral and written).
3.Preferred substantial professional experience (approximately 6-8 years as a guide) in clinical research in CRO or a Pharmaceutical or Biotechnology Industry environment with at least 1 year of them in clinical trial management.
4.Extensive experience in all aspects of clinical trial planning and start up (including budget and resource planning), and in executing the complete range of clinical trial activities, from start up through final trial report.
5.Proven track record of having successfully led one or more multinational trial.
1.Identify and develop clinical research strategies for Reistone products in assigned therapeutic areas.
2.Develop the content writing of clinical research related documents mainly including clinical trial protocol, Investigator’s Brochure, clinical study report and review statistical analysis plan, data management plan, etc. to support clinical trial and meet local registration needs.
3.Provide scientific expertise to related phase I study for product registration as needed.
4.Work as medical monitor in responsible phase III/Ⅱ studies, resolve scientific issues and ensure high quality together with study team.
5.Contribute to the preparation of the dossier and providing answers to the CDE/FDA/EMA in a timely fashion during any stage of clinical trial proceeding.
6.Ensure ICH-GCP, local regulatory and global policy compliance.
7.Ongoing review and develop SOPs as well as standard documentation tool kits applicable to clinical development in Reistone.
8.Provide professional TA/product related trainings to clinical study team members and other related stakeholders.
9.Work as Local Safety Officer to ensure all studies in assigned therapeutic areas strictly follow Reistone SOPs and applicable China/US/Europe laws/regulations.
Role related Qualifications/ Skills:
1.Master or above degree with the major in clinical medicine.
2.At least 2 years of international pharmaceutical industry experience working as CRP or medical expert/scientist, familiar with clinical development strategy drafting, clinical study protocol writing, medical monitoring and CSR drafting according to ICH guidelines and company SOPs.
3.Good understanding of the overall drug development process, clinical trial methodology, China and US regulatory environment, ICH/GCP Guidelines and related FDA/EMA clinical development guidelines.
4.Fluent in both English and Chinese with good presentation skill.
5.Good communication and interpersonal skills - works well with others, motivates and encourages.
6.Demonstrated capability to deliver results under pressure with highly efficient/ elaborative characteristics.
Role Title: Associate Quality control & Training manager / Quality control & Training manager
Reporting to: Associate director of quality control & training
Organization Unit/Country: Reistone Biopharma, China Role Purpose Statement(how does the role impact business achievements?):
To develop and implement quality strategies in clinical operation department, ensure clinical trials conducted according to GCP and SOP requirements in Reistone.To identify training needs, deliver and coordinate training program in clinical operation department. Main Accountabilities:
Develop and implement clinical quality standard and strategy in clinical operation department
Develop a comprehensive clinical quality strategy centered on Reistone SOPs and GCP principles and built-in with the key considerations essential for effective implementation in clinical operation department;
Monitor the implementation of QC guidance;
Work with associate director of quality control & training to develop a clinical quality QC/Co-monitoring plan;
Support the execution of clinical quality monitoring to ensure the highest possible standard of clinical research is maintained;
Be responsible for conducting QC visit which is important part of clinical quality monitoring plan and identify quality improvement actions based on the results;
Provide consultancy to CRAs on clinical quality issues.
Identify, Deliver and Coordinate training program within CMD
Act as a trainer to identify training needs, deliver and coordinate training program within clinical operation department;
Provide training and consultation to Clinical Research Associate;
Coordinate and/or deliver initial and ongoing clinical research related training;
To deliver the new hire orientation training ;
Organize and manage the on line and F2F trainings to ensure that training needs & objectives are met;
Be responsible for incorporating quality issues into training program.
Role related Qualifications/ Skills:
Minimum bachelor degree in clinical medicine or Life/Biological Sciences;
Previous experience in clinical medicine, pharmaceutical and services industry is required;
Minimum of 3 years’ experience in clinical research;
Good command of English (written and spoken);
Knowledge of PC (WORD, EXCEL, POWERPOINT);
Good Presentation and facilitation skills;
Interpersonal communication skill and effective communication skill for a broad range of audiences;
Team player, quick learning, focus on detail.
Role Title:Director/Sr.Director, Head of Biometrics
Reporting to: Chief Medical Officer
Organization Unit/Country: Reistone Biopharma, CN
Role Purpose Statement:
Providing statistical leadership in design, analysis, and interpretation of clinical studies conducted and providing statistical input to clinical and management teams. Representing Statistics function in interactions with regulatory authorities on regulatory submission and regulatory defense. Providing strategic statistical inputs for go/no go decision, development plans and regulatory requirements for programs.
Role / Responsibilities:
• To establish the Biometrics function (statistics, statistical programming and data management).
• To coach statisticians/statistical programmers/data managers assigned to the projects/studies.
• To stay updated on relevant statistical methodology and tools.
• Be aware and updated of any specific guidelines and/or practices most suitable to the health authority requirements to facilitate and accelerate the registration of Reistone products
• To build a network of statistical experts to facilitate the relationship with the Chinese Authorities (CFDA) and to participate in the agency meetings.
• Participate in, or initiate other tasks assigned, e.g. writing or updating SOPs.
• Contribute to clinical development programs & study designs for the development candidates.
• To coordinate evaluation and selection of qualified biometric CROs in China for outsourcing. To act as a project coordinator to ensure efficient CRO management and validation of statistical tasks of the clinical trials.
• Act as a trial-statistician (responsible for study design, statistical section of synopsis/protocol, statistical analysis plan, performing analyses, statistical reports, clinical study reports), if needed.
Qualifications / Competency:
·PhD Degree in statistics/biostatistics.
·At least 4 years’ experience as a biostatistician in the pharmaceutical industry.
·Good knowledge on regulatory statistical guidelines.
·Ability to communicate statistical issues to non-statisticians.
·Effective problem solving skills.
·Good scientific reporting.
·Good working knowledge of SAS.
·Fluent in English.
·Ability to coach others.
Role Title:Clinical Research Liaison
Reporting to: Head of Clinical Research liaison Team
Base city:Shanghai, Beijing, Guangzhou, Hangzhou, Chongqing
Organization Unit/Country:Reistone Biopharma, CN
Role Purpose Statement:
To facilitate patient recuiring in and outside site, support clinic operation team in site selection, site initiation and smooth trial operation.
Role / Responsibilities:
·Provide inputs in site selection and PI selection based upon understanding towards the site, relevant departments and trial related disease knowledge (cooperate with clinic operation team: CRA/PM, familiar with site and departments, justified feasibility assessment)
·Support CRA to initiate site in an efficient way, which includes communicating with GCP center, EC and PI to get approval and contract negotiation and sign-off (cooperate with CRA, engage with stakeholders on site)
·Facilitate on-site patient recruiting in a comprehensive way to meet recruiting timeline and budget,
oDesign, create and deliver multi-channel trial recruiting advertisement
oEngage with PI/investigators to proactively identfity potential subjects, introduce trial contents to potential subjects in an objective way and complete patient consent process (coordinate with PI, CRC and CRA, patient pool, wechat group, HIS, etc)
oAct as liaison on site to provide necessary support to PI/investigators to complete screening and randomizing process
·Develop off-site trial recruiting resources by continuously exploring clinic and academic networking
·Act as general liaison to provide timely and efficient feedback from site to medical and clinic operation team in terms of questions, challenges and suggestions from site and facilitate the follow-up steps (help generating APACT, etc)
·Organize academic meetings to introduce trial designing to related departments (doctors, nurses, test center technicians, etc)
·Comply with all GCP related regulations and process as well as AE report policy
Qualifications / Competency:
·Highly sense of responsibility and integrity
·Competitive learning agility
·Highly sense of urgency
·Bachelor degree or above in Medical, Pharmacy or related areas
·3+ years of sales experience in pharmaceutical, dermatology/reumatoloby product experience will be a plus
·CRA experience will be a plus
·Basic understanding of ICH-GCP/GCP and clinic trial process
·Excellent communication skills with enough interpersonal sensitivity
·Good written, verbal skills, and presentation skills in both Chinese and English
Role Title:Clinical Supply Manger
Reporting to: Executive Director, Head of China Clinical Operations
Role Purpose Statement(how does the role impact business achievements?):
This role is to Liaison between CMC and Clinical Operations, Plant and RA and external vendors to provide clinical supply packging, labeling and distribution strategy and to ensure the clinical supplies be ready by schedule.
1.Liaison between CMC, and Clinical Operations, Plant, Vendors/CRO and Regulatory as project/study team member.
2.Provide clinical supply packaging, labelling, blinding and distribution strategy, and as well as the
budget forecast related to clinical supplies.
3.Provide strategical comparator sourcing plan according to different studies, ie China Local Registration/ China Region, or global study.
4.Development Clinical Supply Agreement among the project team and ensure the implementation.
5.Support the study team to purchase the commercial drug for clinical study used and conduct additional labeling upon request within required timeline.
6.Support study team to arrange and track the destruction of clinical study medication
7.returned from study site and/or stored at local depot upon the authorization from related stakeholder.
8.Provide the study team with monthly clinical study medication inventory report
9.Clinical depot management including depot qualification, process and depot inventory etc.
10.Work with external stakeholders, e.g. customs, service providers, development partners etc.
Role related Qualifications/ Skills:
1.Bachelor degree or above, pharmaceutical science related major
2.Experience in Clinical Research/Development or related industry (appreciated)
3.GMP knowledge on clinical supply management
4.Able to communicate clearly and accurately in both written and spoken English and Chinese
5.Experience working as part of team, and good communication skill with both internal and external.