上海招聘

Responsibilities:

Description :

Assist in protocol development in general and be fully responsible for protocol development of less complicated studies.

Assist in the preparation of clinical component of CDP.

Provide input into the Financial Plan.

Provide input into the Strategic planning of a project.

Provide input for CRF design.

Prepare the clinical science component of the project specific manual.

Provide guidelines for project specific and clinically relevant laboratory parameters.

Provide input and review of SDV plans based on protocol specifications.

Establish glossaries, review and provide input for database conventions, edit checks, data displays, and case report form summaries.

Attend and provide science support for investigator and consultant meetings and monitors workshops.

May accompany operations personnel on site visits as agreed with clinical operations.

Participate in the management of studies and provide training and science input to operation colleagues and study site staff, and serve as trouble-shooter and expert on clinical and medical issues and aspects of assigned studies.

Participate in the ongoing review of study data.

Participate in SAE report process according to SOP's.

Participate in the writing of final study reports.

Participate in NDA documentation and preparation of materials for use in presentation.

Assist in providing response to regulatory agency questions and preparation of advisory committee meetings.

Manage external IND and government collaborative studies including all aspects of clinical drug supply management.

Provide input for phase IIIB or publication studies; review phase IIIB protocols, provide support to marketing on clinical issues.

Coordinate, prepare, and review study results for publications, abstracts, poster presentations and scientific meetings.

Requirements:

Qualification :

· Good clinical research experience, preferably in industry as a headquarter clinical research associate and/or coordinator, with an overall knowledge of drug development process

· Ability to acquire knowledge in different diseases and therapeutic areas, willing to upgrade skills and medical/ scientific knowledge base

· Ability to acquire knowledge in different diseases and therapeutic areas

· A team player with communication and leadership skills

· Excellent verbal and written communication skills in English

· Experience in writing experimental protocols and/ or study results and conclusions

· Ability to process information, analyze data, and reach conclusions based on sound reasoning

· Two to five years of clinical research experience, preferably in industry as a headquarter clinical research associate and/or coordinator, with an overall knowledge of drug development process

· Teamplayer, ability to interact with individuals and groups in other functional areas as well as outside the company

· Good oral and written communication skills

· Self-starter, conscientious

· Technical skills including use of computers (modern office environment), other technical experience might include use of computer generated reports and audio-visual equipment.

罗氏研发（中国）有限公司，位于上海张江高科技园区，是中国第一家由跨国制药企业独资拥有的药物研发中心，我们将通过尝试新的药物研发途径，为国内乃至国际市场提供具有临床差异性的药物。经过5年的发展，罗氏研发（中国）有限公司从早期药物发现工作起步，建立了从早期研究到早期开发全功能的药物研发业务部门，成为一个在中国拥有大批业内专家和广泛合作伙伴的药物研发组织。我们正在寻找药物研发行业内的领军人物加入我们，让我们共同创造医疗保健领域的美好明天。