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.
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.
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.
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.
1.Manage a CRA team of 7-8 employee, to manage their performance, identifying gaps (if any), implementing necessary actions to bridge performance gaps and encouraging continuous improvement.
2.Actively focus on individual development plans within the function.
3.Appraise performance of colleagues on the achievement of targets against predefined objectives and recommend career progression decisions.
4.Understand and ensure project delivery meet study management expectations.
5.Ensure an efficient interface between project management teams and monitoring team to promote teamwork, exchange of information and leverage business opportunities.
6.Assign appropriate resources to studies, Oversight project milestones are met.
7.Prepare regular resource forecasts for CRAs.
8.Responsible for timely availability of trained CRAs.
9.Ensure timely resource allocation of CRAs on studies.
10.Ensure optimal utilization of available resources to reach reasonable productivity.
11.Recruitment of staff with appropriate knowledge, skills, experience and fit for company and department.
12.Provide delivery of new-hire training activities and ensure timely completion of training requirement.
13.As one of the leadership team members, provide input to support strategic and tactical decisions for optimizing site management activities affecting the conduct of clinical trials.
15.Collaborate with QA/QC colleagues/study management team to explore areas for clinical research process improvements in quality and compliance.
16.Ensure regular communication with stakeholders regarding overall CRA capability.
Role Related Qualifications/ Skills:
1.University Degree (a scientific or technical degree in the healthcare area is preferred).
2.BS/MS or equivalent + 5 years of clinical research experience.
3.Thorough knowledge of ICH GCP, regulatory system for the approval and conduct of clinical trials in the country.
4.Leadership, project management, resource management (staff and financial), coaching, change management, administrative, and technical capabilities as well as effective verbal and written.
6.Significant experience in site monitoring.
7.Significant experience in operational aspects of clinical drug development.
8.Independent judgment and decision-making skills with respect to functional responsibilities.
9.Fluency in English language.
10.Expertise in clinical research process and proficiency in clinical research management.
11.Demonstrate understanding of medical/clinical sciences, well-developed planning, observation, analytical and problem-solving skills.
Working Location: Boston
1.Independently perform and manage day-to-day product registration operations and ensure timely completion of the registration tasks assigned, in compliance with local applicable laws, regulations, guidelines, and policies and SOPs.
2.Assist in the development of product registration strategy and action plan as well as regulatory affairs activities assigned.
3.Draft product registration strategy plan for review and approval
4.Compile registration dossier and prepare other regulatory documents (e.g., package insert, packaging components) and ensure timely regulatory submission upon internal review and approval
5.Coordinate internal departments in product registration process
6.Communicate with regulatory agencies/institutes (e.g., FDA, NICPBP) on product registration
7.Timely /closely monitor regulations and review process for ensuring the data presented fully represent what is practically required and the constantly changing regulations to be followed. Meet or accelerate Regulatory milestones
8.Properly maintain all regulatory documentation.
1.5 or more years of pharmaceutical industry experience in R&D, Regulatory or related functions, with at least 3 years working in regulatory affairs
2.A minimum of bachelor degree, preferable higher, (pharmacy, medical or related background)
3.Experience with least one major marketing application (IND/NDA/BLA/MAA/JNDA etc…), or extensive experience with late stage development
4.Self-motivated to achieve challenging goals
5.Demonstrated communication skills
6.Knowledge, Skills and Other Experience: Strategic, Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance, direct interaction/negotiation with regulatory authorities (e.g. CFDA, FDA, EMA)
7.Understanding of the US pharmaceutical marketplace and familiarity with medical terminology.Understands issues, problems, and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution.
Working Location: Boston or Shanghai
1.Build up the DMPK and Clinical Pharmacology Team to support the pre-clinical and clinical development and regulatory filing activities by applying pharmacokinetic and pharmacodynamic data acquired at various development stage
2.Ensure High quality contribution to development strategies
3.together with clinical project teams for product development and registration.
4.Define PK, PK/PD, BE requirements in all development projects in accordance with the CFDA, FDA and EMA requirement
5.Identify laboratory for new assay and ensure technology transfer as needed
6.Represent the PK/PD discipline and ensure high quality interactions with various health authorities, external investigators and internal stakeholders
7.Represent the company in the engagement with external CRO ensuring successful design, planning, and delivery of PK trials.
8.Play key role in the review and interpretation of PK data. Through the in-depth understanding of the PK profile, able to advise and enable the clinical them to design the next phase of clinical trial
9.Able to design and develop plan for early PK/PD strategy for new assets
10.Serve as DMPK expert in the integrated research and early development project team; lead the study design and coordinates PK/modeling related elements for projects
11.Contribute expert PK/modeling inputs into key pre-clinical, clinical and regulatory documents including clinical study protocols, clinical study reports, investigator brochures, IND / IMPD’s within agreed timelines, and meeting all regulatory requirements under minimal guidance from manager
12.Oversees PK, PB/PK, PK/PD, DMPK biopharmaceutical and M&S performed with a variety of tools and approaches. Review and ensure analysis plan and report timeline and quality
13.Maintains good collaborative relationships with CRO/Partners and ensure high quality standards of their deliverables.
14.Maintains and enhances technical and drug development expertise (e.g. training courses, external meeting attendance)
15.Attends meetings with external parties including investigators, outside experts, and health authorities.
1.PhD in Pharmacokinetics, Drug Metabolism, Pharmaceutics or related field.
2.A minimum of 5+ years of industrial experience in clinical PK/PD of small molecule drug R&D.
3.Expert knowledge of preclinical DMPK and clinical PK, PBPK M&S, and PK/PD analysis.
4.Good understanding and knowledge on drug research and development.
5.Good people management skill and experience.
6.Good understanding and knowledge on LC-MS/MS bioanalysis.
Good verbal and written communication skills in both Chinese and English
Working Location: Boston or Shanghai
1.Primary accountability for developing indication selection and translational biomarker, DMPK, Toxicology and CMC strategies in collaboration with Research and Clinical Teams that assess proof of target engagement, and/or pharmacodynamics activity, establish early signs of efficacy, enabling proof of concept studies, and understanding disease progression.
2.Partner with drug discovery scientists to design and execute translational research to discover and validate pathways and biomarkers associated with mechanism of action and drug response.
3.Serve as a key strategic resource for exploratory biology, experimental medicine, and clinical science teams – providing key biological validation by leveraging insight gained from patient-derived functional, genetic, and biochemical biomarkers.
4.Develop and coordinate patient selection, biomarker/DMPK/Toxicology/CMC and companion diagnostic strategies for projects across Reistone’s growing portfolio.
5.Support global regulatory strategy and contribute to the generation of investigator brochures, IND applications, clinical protocols and other regulatory documents as appropriate. Supports scientific input and review of all translational medicine aspects of clinical and regulatory documents, including but not limited to development plans, study protocols, clinical study reports, regulatory submissions and responses to any regulatory questions, etc.
6.Provide deep domain area expertise to discovery and development project teams and further enhance Reistone’s scientific reputation through high impact publications and presentations.
7.Function as a scientific and business thought-leader inside and outside of the company and a key link to external community.
8.Support Business Development efforts by supporting potential in-licensing opportunities and serve as a liaison with external companies, organizations, consultants, university representatives, NIH, and with FDA, as required.
9.Works closely with discovery stakeholders to understand evolving project portfolio, identify knowledge gaps related to target diseases, and prioritize resources needed for specific assets.
10.Partners with discovery colleagues on internal studies, consortium work, or academic collaborations as needed.
11.Consults with project teams on discovery, pre-strategic assessment of indications for clinical samples profiling and understanding of mechanism or disease related biology.
12.Lead the team to collaborates with research and clinical colleagues to develop scientifically rigorous translational and related strategies that assess proof of mechanism, establish early signs of efficacy, enable proof of concept studies, and generate an understanding of the variability in patient response.
1.PhD in molecular/cell biology, biochemistry, medicine or immunology with relevant post-doctoral training.
2.8+ years of pharmaceutical or biotechnology industry experience in biology discovery and companion diagnostics.
3.Strong interpersonal, influencing and collaboration skills to work in a team-oriented, matrix environment, and the ability to work through conflicts.
4.Ability to drive and influence projects from discovery through early clinical development with a focus on the identification of indications with biomarkers of response and/or resistance to therapy.
5.In depth experience in the discovery, validation and clinical implementation of innovative biomarkers and companion diagnostics.
6.Excellent management skills, including the ability to set high but reachable goals, define priorities, manage individual performance, and infuse the team with a sense of purpose and urgency.
7.Thorough understanding of clinical development and discovery research, and analytical and clinical validation of biomarker assays /DMPK etc.
8.Familiarity with data management and visualization tools and collaborating with computational biology to analyze complex genomic data sets emerging from clinical trials.
9.Excellent communication skills, ability to present the results in clear and concise manner.