长沙招聘

职位描述：

JOB PURPOSE:

The Associate Clinical Trial Operations Manager (Associate CTOM) performs monitoring activities for CEP studies.This includes,but is not limited to,the conduct of site visits (initiation,intern monitoring visits,and close out visits),and the review of the Case Report Form,Source Date Verification/Monitoring Plan and other sponsor and site-generated study documents.

Depending on his/her experience,the Associate CTOM is responsible for the overall operational planning and activities for the implementation and conduct of clinical exploratory pharmacology clinical trials in compliance with ICH,GCP’s,SOPs,local requirements,internal/departmental guildelines,and established timelines.The Associate CTOM is involved in the scientific conduct of the clinical trial and acts as the leader of operational disciplines (Clinical Trial Team(CTT)) to guarantee release of homogeneous high quality clinical data in close collaboration with the CEP Date Manager (DM) and Clinical Study Director (CSD).

The job may include international responsibilities



KEY ACCOUNTABILITIES:

Decision Making Authority:





The Associate CTOM should make study logistic decisions in collaboration with the CTT (can be performed in collaboration with their CTM or senior CTM,when applicable) and may need to consult with the Site Manager for operational issues that could affect study/program timelines or quality.





The Associate CTOM is planning the Global Study schedule as well as his/her own travel schedule for monitoring purpose in conjunction with the Data Manger (can be performed in collaboration with their CTM or senior CTM，when applicable).





During monitoring visits,monitors have direct access to subject individual data for records review.Monitors are bound by professional secrecy and as such will not disclose any individual identity and/or individual medical information.











PRINCIPAL DUTIES AND RESPONSIBILITIES





Provide management and oversight of clinical trials to ensure progress according to study timelines (can be performed in collaboration with a CTM or Senior CTM depending on the Associate CTM experience or study complexty)






Lead the Clinical Trial Team (CTT) including representatives of all operational disciplines involved in the conduct of trial (i.e.,CRAs/CROs,Date Mangement,Pharmacokinetics,Clinical Supplies and other relevant departments,platforms or units).



Mange the study according to Good Clinical Practices (GCPs) and other local and/or national regulations.



Collaborate with team members on a day-to-day basis in particular with the Data Manager (DM) and the Clinical Study Director (CSD).







Anticipate bottlenecks in all steps of the study and development/implementation of counteractive measures



Solve or coordinate the resolution of issues during conduct of the trial



Develop and review specific study-related documents



Develop and coordinate the study budget,including invoice validation



Contribute to contract process



Manage investigational product supplies (ordering,packaging,and shipment)



Participate in and contribute to internal audits,if applicable



Serve as main contact for clinical sites







Collect,synthesize,report,file and prepare archiving for clinical trial activities



Manage CRO/study sites (can be performed in collaboration with a CTM or Senior CTM,when applicable).







Escalate quality issues and delays in deliverables,propose solutions,request and ensure follow-up actions



Assess CRO performance by completing CRO post services assessments



Conduct yearly CRO assessment,if applicable






Conduct field monitoring activities when required






Set-up and manage site visits (Site Initiation Visit,Interim Monitoring Visits,Closure Visit) including in-house preparation such as data listings review



Conduct source data validation and other monitoring activities (according to the study-specific Monitoring Plan if applicable)



Use eCRF tool for ongoing data review and query generation



Regulary review and reconcile the Investigator Study File,Investigational Product accountability and biological sample management



Report visit progress /findings to CTM/Senior CTM (if applicable), CSD,other relevant members of the CTT and Site manager.





COMPLEXITY & PROBLEM SOLVING







Major Challenges/Problems

To negotiate effectively with all CTT functions and achieve common agreement and alignment across CTT functions to ensure delivery of study nilestones (can be performed in collaboration with their CTM or senior CTM,when applicable).

To check that the site is compliant with sponsor requirements,general regulations and local law.

To manage,solve and follow-up site0related issuss.



Key Internal and External Relationships.

Internal contacts:CEP-OP Site Manager,CEP-OP Senior Site Coordinator,CEOP Expert Data Management Coordinator,CEP CTM(a)s,CEP DM,CEP CSDs,CEP DPEs

External contacts:CSO SCP departments (e.g.DSAR,Supply Chain)，Units project leaders,Clinical Study Units (CSUs)/affiliates if applicable,Regulatory,Pharmacovigilance,Finance,Legal,Clinical Purchasing

Outside the company:Clinical Research Organizations (CROs),clinical trial vendors (e.g.,ECG central readers),Academic Research Organization,External Steering Committee Members,Data Monitoring Committee members,Key opinion leaders & medical advisors if applicable.



JOB-HOLDER ENTRY REQUIREMENTS:

Education and experience required:







+5 years (Bachelor’s Degree)



CEP related experience or field monitoring experience is required (approximately 3 years)






Strong English communication skills(verbal and written) if English is a second language.

Knowledge and skills:





Previous experience with medical terminology(basic knowledge in medicine,laboratory procedures/techniques and biological knowledge is preferred) and GCP/ICH guidelines





General understanding of R&D process including the principals of study design and execution





Understanding of compound/product related training





Good leadership skills





Interpersonal and communication skills (verbal and written)





Ability to work in a team environment





Self-motivation, attention to detail and organizational skills,flexible and goal-oriented





Ability to build good collaboration within the company and with external partners





Experience with various computer systerms/database;a willingness to learn new systerns/databases





Ability to prioritize activities





Results-driven in terms of timelines and quality





Knowledge and skill desirable but not essential:





Previous experience with clinical trials management preferred.

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