[北京]百托摩尔管理咨询（北京）有限公司2011招聘

500强欧美外企和Golbal CRO公司招聘信息

岗位名称

1.Clinical Submission Specialist

City:  Beijing   wuhan   shanghai

Duties and Responsibilities (according to relevant guidelines, laws and SOPs):

1.      Ensure ongoing awareness of EC/CA submission deadlines, meeting dates and procedures and communicate to start up team members as appropriate.

2.      Arrange payment of EC/CA fees.

3.      Work with start up CRA(s) to ensure the essential documents are in place to obtain regulatory, ethics and provincial application approvals within agreed timelines.

4.      Liaise with the CRAM to prepare and submit regulatory, ethics committee and provincial applications and regulatory packages.

5.      Liaise with the CRAM to prepare and submit special national or local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license, etc.

6.      Liaise with regulatory authorities, ethics committees and investigators where applicable, to facilitate and ensure EC/CA applications are managed in a timely manner.

7.      Coordinate responses to any EC/CA questions in a timely manner as required.

8.      Report on progress to CRAM and project team for CA/EC application status.

9.      Work with the start up CRA (s) to prepare the regulatory compliance review packages.

10.   Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.

11.   Maintain a working knowledge of ICH/GCP, SOPs WPDs and applicable client SOPs.

12.   Liaise and inform CRA(s) of EC/CA progress and site communication throughout the life cycle of the project.

13.   Enter and maintain trial status information relating to start-up activities onto tracking databases  ( e.g. CASCADE & Pulse )in an accurate and timely manner.

14.   Support the coordination of feasibility activities, as required, in accordance with agreed timelines.

15.   Liaise with other departments as required.

16.   Liaise with the CRAM to prepare and submit regulatory, ethics committee and provincial application amendments throughout the life cycle of the study.

17.   Sharing of ideas and suggestions with team members ensuring effective communication within the Start-up Team.

18.   Facilitate and respond to company, client and regulatory audits where required.

Qualifications:

A degree in a science related field or equivalent by experience is required

Skills and Knowledge:  

· Effective oral and written communication skills

· Excellent interpersonal skills

· Strong attention to detail

· Good computer skills and the ability to learn appropriate software

· Good English language and grammar skills

· Basic medical/therapeutic area and medical terminology knowledge

· Ability to work in a team or independently as required                      

Experience:

Experience with handling of EC/CA applications is desired as well as a good working knowledge of ICH/GCP, SOPs, WPDs and applicable client SOPs.

2.  CRA

City：beijing shanghai  wuhan

Main job activities/tasks
Study Planning/set-up activities
􀂃 When required, assist LTM to conduct site feasibility
􀂃 conduct Pre-trial visits to assess the investigational staff and facilities
􀂃 Discuss the items listed on the PAR with the investigator and other appropriate staff
􀂃 Review the site commitment in detail with the investigator
􀂃 Develop/adapt recruitment and retention strategy for the site
􀂃 Ensure all required trial-related materials and supplies are provided to the
investigational site
􀂃 Ensure that the investigators send the SUA gap pack to the IEC/IRB, when the
sponsor is not responsible for sending safety information to the IEC/IRB
􀂃 Set up the IF and TCF
􀂃 If needed, development of site-specific ICF
􀂃 Ensure that the investigational staff are instructed on the requirements for proper
informed consent
􀂃 When local Ethics Committees are used, ensure that the IEC/IRB is provided with
current and complete copies of all documents that the IEC/IRB requests to fulfill its
obligation and obtain a copy of the valid written IEC/IRB approval and all related
required documents, including the composition of the IEC/IRB
􀂃 Obtain site related trial documents and review them for completeness and accuracy
􀂃 Negotiate investigator budgets at site level and track the status of site CTA
􀂃 Plan and conduct investigator and site-staff training
􀂃 Conduct site initiation visits
􀂃 If applicable, execute the user acceptance testing plan
􀂃 If applicable, create site specific and monitoring tools
Monitoring activities
􀂃 Notify the GTM and the Local CSC in writing, when a country and an
investigational site is approved to receive clinical drug supplies
􀂃 At the investigational site, ensure clinical drug supplies are available,
appropriately used, handled, stored (e g , temperature logs, security), and
returned, accurately inventoried and documented. Inform the investigational staff
of the distribution process
􀂃 Conduct monitoring visits according to the checklist of activities listed on the
Monitoring Visit Report
􀂃 Report to LTM on study site status through monitoring report and meetings
􀂃 Document all study related communications
􀂃 Perform SDV to ensure accurate data is recorded based if required
􀂃 Follow up with the trial site(s) regarding completion of case report forms and data
correction forms within required timeframe
􀂃 Ensure that all AEs/SAEs/PQCs are reported within reporting timelines and
documented as appropriate. For AEs/SAEs ensure they are consistent with all data
collected and with the information in the source documents
􀂃 Ensure that the investigators send the safety reports to the IEC/IRB, when the
sponsor is not responsible for sending safety information to the IEC/IRB
􀂃 Arrange for the appropriate destruction of clinical drug supplies

Ensure that the investigational staff stores the randomization codes in a limited
access area that is accessible 24 hours a day and instruct them on the codebreaking
procedure
􀂃 In studies where IVRS/EDC are used, ensure that the IVRS/EDC at the site work
smoothly during the study.
􀂃 Track costs at site level and ensure payments are made with planned payment
schedule
􀂃 Ensure TCF is maintained as required and maintain IF
􀂃 Ensure subject commitment per site is met
􀂃 Conduct site closure visit according to the checklist activities listed on the site
closure report
􀂃 If applicable, remind the investigator to notify the IEC/IRB of the site closure
􀂃 Ensure the IF is complete and accurate
􀂃 Provide study report synopsis to investigators, IEC/IRBs
􀂃 Check the Site details on Appendix 1 documents and provide feedback to the LTM
􀂃 Follow up on and resolve any pending issues, including adverse events and IFDFs
one year post-trial
General activities
􀂃 Represent the company and the organization adequately to the customers and
other external parties
􀂃 Base all actions on Credo
􀂃 Protect the rights of others, protect privacy and company assets, particularly
information as the key asset
􀂃 Conduct business in line with the HCC, company policies and procedures,
including applicable SOPs, always having the ethical aspect in mind
􀂃 Maintain adequate communication with relevant parties within and outside the
company
􀂃 Comply with ICH-GCP and all applicable local laws and regulations
􀂃 Actively follow trainings to ensure adequate qualification for performing jobrelated
tasks
􀂃 Report (suspicion of) fraud or scientific/ethical misconduct as appropriate
􀂃 Regularly update information in applicable systems and templates
􀂃 Contribute to the development and improvement of departmental procedures and
processes and templates in the scope of the company’s effort towards continuous
quality improvement
􀂃 Maintain quality standards and timelines that are consistent with business needs

任职资格和胜任力：

A. 教育/培训背景:
    具有医学或相关专业背景，学士或以上学历。
B.   知识/技能:
§ 掌握新药研发相关的临床研究知识；
§ 熟悉ICH-GCP、SOP及相关新药临床研究的法律法规；
C.  工作经验:
   较强的国际多中心及注册临床试验的监查能力；
§一定的国际多中心及注册临床试验的项目管理能力；。
   有２-3年以上国际多中心临床试验或中国注册临床试验监查经验

D. 胜任力:
   有较强的组织和沟通能力及影响力， 能快速建立有效的人际沟通，较强的独立解决问题的能力
E.  其它要求: 
    英语听、说、读、写均流利，与全球临床试验项目人员进行有效的试验相关的专业沟通；
   熟练使用计算机进行操作

3.Medical Scientific Liaison

Job Purpose：

与领域内专家学者建立信任关系，系统分析并支持marketing和销售部门，

Build scientific partnerships Phase II forward with healthcare professionals and decision makers to build advocacy. Strategically prepare and support the development, launch and commercialization of drug products through education of KOLs/Key Stakeholders, education of the scientific community and KOLs, clinical trial support, and by the scientific exchange seeking external insight to shape Novartis commercial and development programs.. Compliance with applicable policies, procedures and other regulations.

Major Accountabilities：

KOL Management & Medical Support

1.    Contributes to mapping / profiling of KOL/decision makers in line with segmentation .

2.    Develop professional relationships, build advocacy and gain contributions of KOL/decision makers.

3.    Collect, analyze and report insights (i.e. CRM System) that may impact No-vartis development plans /trial designs.

4.    Provide and discuss scientific information and data to healthcare profes-sionals to ensure quality and accuracy of medical and scientific information on new treatment options including Novartis products and selected areas of therapeutic in-terest.

5.    Liaise and provide up-to-date medical support to relevant external groups to facilitate listing of products in medical guidelines, formularies to impact pricing and health-economic discussions.

6.    Provide speaker training to health care professionals to support the best use of new therapies developed and commercialized by Novartis.

Clinical Development Support

7.    Contribute to the identification of appropriate clinical investigators and facili-tates placement into Novartis sponsored clinical trials.

8.    Support the investigational sites, as needed , as part of a cross-functional team with ICRO and the Medical Advisor and others as appropriate.

9.    Identify clinical investigators with research proposals that are consistent with our product development strategies and facilitate the Investigator-Initiated Research Protocol (IIRP) process including study completion, presentation, and publication, as appropriate.

10.    Support the investigators to comply with the IIRP process in accordance with the guidelines and NIPs, providing knowledge and guidance for legal and fi-nancial local regulations, as appropriate.

Ideal Background

Education & Required:

strong scientific merit – must be perceived as a peer by the customer base. MD, PharmD., pharmacist, PhD, advanced degree in medical or other life sciences with Oncology medical/technical background and proven competencies including communication, presentation, and negotiating skills, clinical research insight, business and market knowledge.