Clinical Research Expert
Roche / Genentech · Beijing, China
About the role
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position Job Summaryèä½æ¦è¿°: 1. Independently plan and execute clinical development activities for new clinical software, instrument platforms, IVD assays, medical devices, etc. developed globally by the Roche Diagnostics, ultimately supporting product registration in China. Manage all phases of clinical clinical development, in strict compliance with company SOPs, policies, divisional standards, the Declaration of Helsinki, relevant GxPs, NMPA regulations, and other international requirements or industry best practices. ç¬ç«è§å并æ§è¡ä¸´åºå¼åæ´»å¨ï¼ä¸ºç½æ°è¯æå¨å ¨çå¼åçæ°å临åºè½¯ä»¶ã仪å¨å¹³å°ãä½å¤è¯æè¯åãå»çå¨æ¢°ç产åå¨ä¸å½ç注åæä¾æ¯æãä¸¥æ ¼éµå®å ¬å¸SOPãæ¿çãé¨é¨æ åãã赫å°è¾åºå®£è¨ããç¸å ³GxPè§èãNMPAæ³è§åå ¶ä»å½é è¦æ±ä¸è¡ä¸æä½³å®è·µã 2. Conduct comprehensive information gathering and evaluation for proposed registrational products to formulate optimal clinical strategies and clinical evaluation pathways. Furthermore, accurately assess and determine clinical trial timelines and budgets based on the defined pathways. 对æ注å产åè¿è¡å ¨é¢çä¿¡æ¯æ¶éä¸è¯ä¼°ï¼å¶å®å½åæä¼ç临åºçç¥ä¸ä¸´åºè¯ä»·è·¯å¾ï¼åæ¶ï¼è½å¤åºäºæ¢å®çè¯ä»·è·¯å¾ï¼åç¡®å®æ临åºè¯éªæ¶éä¸é¢ç®çè¯ä¼°ã 3. Be familiar with product characteristics, regulatory guidelines, and expert consensus within relevant therapeutic or diagnostic fields. Independently design scientifically rigorous clinical trial protocols. çææ注å产åçç¹ç¹åç¸å ³é¢åçæ导ååä¸ä¸å®¶å ±è¯ï¼è½å¤ç¬ç«è®¾è®¡ç§å¦ã严谨ç临åºç 究æ¹æ¡ã 4. Leverage expertise in relevant disease areas and product performance metrics to independently author scientifically rigorous clinical study reports (CSRs) and academic publications. è¿ç¨å¯¹ç¾ç é¢åå产åæ§è½ææ çä¸ä¸ç¥è¯ï¼è½ç¬ç«æ°åç§å¦ã严谨ç临åºç 究æ¥ååå¦æ¯æç®ã 5. Maintain profound knowledge of regulatory requirements, continuously monitor regulatory trends, and timely assess their impact on ongoing projects. çæå项æ³è§è¦æ±ï¼å¯åå ³æ³¨æ³è§å¨æï¼å¹¶è½åæ¶åæä¸å¤æå ¶å¯¹é¡¹ç®äº§ççå½±åã 6. Demonstrate an understanding of company and departmental policies, SOPs, and cross-functional business linkages. Drive continuous innovation and propose agile solutions to optimize operations. çè§£å ¬å¸åé¨é¨çå项æ¿çãè§ç« å¶åº¦ãSOP以åè·¨é¨é¨çä¸å¡ååå ³ç³»ï¼å ·å¤æ¨å¨åæ°çè½åï¼è½å¤æåºæ´ä¸ºææ·ãé«æçä¸å¡å»ºè®®ã 7. Proactively identify, evaluate, and mitigate emerging risks within a dynamic and changing environment to ensure smooth trial execution and operational continuity. å¨å¨æååçç¯å¢ä¸ï¼è½å¤æéãææå°è¯å«æ½å¨çæ°é£é©ï¼å¹¶å®æ½åççé£é©æ§å¶æªæ½ã Main Tasks & Responsibilities主è¦å·¥ä½èè´£ : 1. Develop optimal clinical strategies and clinical pathways for proposed registrational products, including comprehensive timeline and budget assessments. è´è´£å¶å®æ注å产åçæ佳临åºçç¥å临åºè·¯å¾ï¼å¹¶å®æå ¨é¢çæ¶éä¸é¢ç®è¯ä¼°ã 2. Design feasible clinical trial timelines by integrating product characteristics with regulatory guidelines, clinical practice standards, and expert consensus; independently author clinical trial protocols. ç»å产åç¹ç¹ãç¸å ³æ³¨åæ导ååãè¯çæååä¸å®¶å ±è¯ï¼å¶å®åçç临åºè¯éªæ¶é´è®¡åï¼ç¬ç«æ°å临åºè¯éªæ¹æ¡ã 3. Proactively identify and mitigate risks during clinical study execution to ensure smooth and successful study completion. 主å¨è¯å«ä¸´åºç 究æ§è¡è¿ç¨ä¸çé£é©å¹¶è¿è¡åçæ§å¶ï¼ç¡®ä¿ä¸´åºç 究顺å©å®æã 4. Independently author logically rigorous clinical study reports (CSRs) and high-quality scientific publications. ç¬ç«æ°åé»è¾ä¸¥è°¨ç临åºç 究æ¥ååé«è´¨éå¦æ¯æç®ã 5. Maintain close liaison with the NMPA; coordinate and lead communications with reviewers during the regulatory evaluation process until all clinical deficiencies/queries are adequately resolved. ä¸ NMPA ä¿æå¯åæ²éï¼è´è´£äº§å注å审è¯æé´ä¸å®¡è¯åçæ²éä¸åè°ï¼ç´è³ææ临åºåè¡¥é®é¢å¾å°ææ解å³ã 6. Coordinate internal cross-functional teams and external investigators (as applicable) during clinical development, optimizing both internal and external resources to meet overall scientific objectives and drive project success. ç»ç¹åè°ä¸´åºå¼åè¿ç¨ä¸çå é¨è·¨åè½å¢éä¸å¤é¨ç 究è ï¼å¦éç¨ï¼ï¼é«ææ´åå å¤èµæºï¼ç¡®ä¿é¡¹ç®ç¬¦åæ´ä½ç§å¦ç®æ 并åå¾æåã 7. May represent the company as primary contact on projects and conduct other projects or tasks assigned by line manager. å¯ä»£è¡¨å ¬å¸ä½ä¸ºé¡¹ç®ç主è¦è系人ï¼å¹¶å®æ主管ææ´¾çå ¶ä»ä»»å¡ã 8. If apply, develop and maintain a good working relationship with BAs and other dept. to support the cross-functional projects å¦éç¨, å¼æ并维æ¤ä¸ä¸å¡é¨é¨åå ¶ä»é¨é¨çè¯å¥½å·¥ä½å ³ç³»ï¼ä»¥æ¯æè·¨é¨é¨é¡¹ç®ã 9. Conduct business in full compliance with all corporate policies and legal requirements, including but not limited to Roche Secure, Roche Behavior in Business, Roche Competition Law Interactive Dialogues, and Roche Safety, Security, Health and Environmental Protection (SHE). ä¸¥æ ¼éµå¾ªç½æ°çææåè§è¦æ±ï¼åæ³åçå°å¼å±ä¸å¡æ´»å¨ï¼å æ¬ä½ä¸éäºï¼ç½æ°ä¿¡æ¯å®å ¨ãç½æ°åä¸è¡ä¸ºååãç½æ°ç«äºæ³äºå¨å¯¹è¯ãç½æ°å®å ¨å¥åº·ä¸ç¯å¢ä¿æ¤ï¼SHEï¼çã 10. Understand and fulfill the SHE tasks and duties required of a line manager (as defined in the SHE handbook). äºè§£å¹¶æ§è¡ç´çº¿ç»ççSHEèè´£ï¼è¯¦è§SHEæåç¸å ³å®ä¹ï¼ã Basic Requirements of the Jobåºæ¬ä»»èèµæ ¼: Education & Qualificationsæè²èæ¯ä¸ä¸ä¸èµæ ¼: 1. Master's degree or above in Medical Sciences, Life Sciences, or a related field. Majors in Clinical Medicine, Medical Laboratory Science, Preventive Medicine, Pharmacy, or related fields are highly preferred. å»å¦ãçå½ç§å¦æç¸å ³ä¸ä¸ç¡å£«å以ä¸å¦å;ä¼å èè临åºå»å¦ãå»å¦æ£éªãé¢é²å»å¦ãè¯å¦çç¸å ³ä¸ä¸ã 2. Proficiency in English language skills çç»ææ¡è±ææè½ 3. Good command of MS/Google office software application çç»åºç¨å¾®è½¯/è°·æåå ¬è½¯ä»¶ 4. Understand medical device (including IVD) regulations and medical device GCP. äºè§£å»çå¨æ¢°(å«ä½å¤è¯æè¯å)æ³è§,åå»çå¨æ¢° GCP Experienceå·¥ä½ç»éª: 1. Minimum of 7 years' experience in clinical research, or clinical development, within the pharmaceutical, medical device, in-vitro diagnostics (IVD), or CRO industries. å ·å¤è³å°7å¹´å¶è¯ãå»çå¨æ¢°ãä½å¤è¯æè¯åæ CROè¡ä¸ç临åºç 究ã临åºå¼åç¸å ³å·¥ä½ç»éªã 2. Effective oral and written communication skills; able to get ideas across face-to-face, in group settings as well as in presentation é«æçå£å¤´å书é¢æ²éæå·§; è½å¤å¨é¢å¯¹é¢,å°ç»æ¼ç¤ºä¸è·å¾ä¿¡æ¯ 3. Have the capacity to resolve complex problems through in-depth evaluation of various factors å ·å¤éè¿å¯¹åç§å ç´ çæ·±å ¥è¯ä¼°æ¥è§£å³å¤æé®é¢ 4. Have the capacity to resolve conflicts constructively from the perspective of all stakeholders è½å¤ç«å¨å个å©çç¸å ³è çè§åº¦,建设æ§å°å解çç¾ 5. Have the capacity to identify and gain support from others to achieve recognition and solutions è½å¤è¯å«åè·å¾ä»äººçæ¯æ,并达æå ±è¯è·å¾è§£å³æ¹æ¡ 6. Have the capacity to communicate and coordinate with multi-functional team å ·å¤å¤èè½å¢éçæ²éååè°è½å Travel Requirements åºå·®è¦æ±: 1. Approximately 20% of time local and/or international travel. 大约20%çæ¶é´æ¯æ¬å°å/æå½é åºå·®ã Who we are A healthier future drives us to innovate. Together, more than 100â000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Letâs build a healthier future, together. Roche is an Equal Opportunity Employer. We believe itâs urgent to deliver medical solutions right now â even as we develop innovations for the future. We are passionate about transforming patientsâ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.
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