Beijing, Beijing, China
1 day ago
高级经理,临床研究中心负责人

 

Work Your Magic with us!  

 

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

 

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

 


Your role:

 Site Oversight & Delivery Activities

Establish and manage site relationships, including but not limited to:Act as liaison between the company and investigational sites, building investigator and site staff awareness on company compoundsDevelop and implement a plan, in collaboration with global and local teams, to raise the profile of the company and its global clinical development projects with current and potential investigatorsIndependently perform activities associated with the evaluation of investigational sites to build company networkProactively work with Medical/Patient/Industry Associations to build company network and to promote company clinical trialsDevelop knowledge of site capabilities and past performance to assess their potential as participating sites in Company clinical trialsEnsure regular communication with local organization to align interactions with KTLs and other relevant local/regional stakeholdersOversee site-level study start-up, conduct, and close-out activities outsourced to CRO(s) for global programs across Therapeutic Areas, including but not limited to:Support Site Agreement negotiations, including stand-alone and Master Site AgreementsIdentify trends, issues and risks across sites, and work with external vendors and internal Trial Team to resolve/mitigate thoseCollaborate with external vendors and internal Trial Team, to ensure that sites are activated in a timely manner and according to agreed timelinesCollaborate with external vendors and internal Trial Team, to ensure that sites deliver on expected recruitment targets, including identifying reasons for non-recruitment, and identification of non-performing sites that require actionsEnsure ICH/GCP/local regulatory requirements are observed  Provide documented sponsor site oversight at country level for outsourced trials in country under remit as required by regulationUtilize site performance and quality data to optimize prioritization of oversight actions

   

In addition, employee may be assigned one or more ‘added value’ roles:
 Therapeutic Area Expert Assignement

SME with focus to increase disease knowledge within the team by sharing materials (training/articles/abstracts) and/or arranging training sessions

 Country Start-up Specialist Assignment

Ensure that clinical sites in country(ies) of responsibility are activated within agreed timeframe and company agreed cycle timesWork closely with respective Clinical Site Leads to support them in issue resolution for site activationCollaborate with external vendors to identify process(es) requiring improvement at the country level, build action plans to strengthen/improve those and track impact of action

 Clinical Trial Delivery Lead Assignment

Identify trends and issues within/across assigned trial(s) which may impact key deliverables (e.g. timelines/quality/costs) and implement action plans to either resolve and/or mitigate thoseAdvise the Trial Team on trends/issues and facilitate solutions, working closely with the CTL to ensure Corrective & Preventive Actions are defined and implemented. Raise awareness of such trends/issues with Clinical Site Leads and other internal and external stakeholders as appropriate, including ICSO/CTE LeadershipDevelop, implement and follow up on strategic action plans to drive improvements in site activation and/or enrolment, in collaboration with the CTL, CRO(s) and working closely with the respective Clinical Site LeadsParticipate in Investigator/Study Coordinator Meetings and promote information sharing with the Clinical Site Leads as needed

 

Who you are:

Education and Work Experience:

Requires graduate background (Medical or Life Sciences degree) in a clinical research related discipline or equivalentDetailed understanding of all aspects of clinical protocol design and implementation, clinical site monitoring as well as overall global drug developmentExpert knowledge of clinical development (principles and concepts as well as regulatory environment e.g. ICH GCP and applicable regional/local regulations)Oncology and/or Neurology and/or Immunology TA experience desiredSubstantial (8+ years) experience in clinical operations in a CRO, pharma or biotech company including site management/oversight, and site-level clinical study conductStrong communication skills (verbal, written and listening) in both native language and EnglishAptitude to interpret and to integrate site performance data in prioritization of oversight activitiesEnsuring compliance with applicable T&E Policy requirementsRole requires domestic and international travel up to 50% of timeAbility to work independently on assigned tasks or projects of increasing complexity  Capability to perform self-training incl. on therapeutic area, and synthesize the key take-away points for studies under remitNormally receives no instruction on routine work and only general instruction on new assignmentsSound negotiation skills and adapting to a variety of partiesRecord of vendor interactionsSound critical thinking skills and ability to understand complex patient histories, medical terminology and specific therapeutic area treatment landscapesDetail-oriented, organized and committed to quality and consistencyResults driven and capable of managing competing high-priority assignmentsProven track record of achieving deliverables within specified timelinesAbility to work in a dynamic environment with a high degree of flexibilityAbility to communicate effectively with Key Opinion Leaders, site staff, and internal team members Experience and proven proficiency in CTMS and eTMF systems preferred


What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!

 

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