Job Description
The Position
Responsibilities
Assume the Country Study Lead role in the PDMA studies
Assume Country Study Specialist (CSS) and Study Start-up Specialist (SSUS) roles
Execute all start-up activities prior to site activation on assigned studies, according to regulatory and ethics requirements, Roche standards, study timelines and budget
Provide country-level and site-level oversight activities on global and Affiliate's local clinical trials including but not limited to interventional study, ensuring compliance to Good Clinical Practice (GCP), Roche standard operating procedures (SOP), and local regulations
Work with global study team and Country Study Manager (CSM) to manage and support day to day activities of the study
Create study budget and negotiate contract in compliance with the fair market value (FMV) in the country
Support the non-interventional and investigator initiated studies, in collaboration with the Medical Affairs Team and the Evidence Generation Lead or Real World Data Lead.
Provide leadership and support to the Contract Research Organization (CRO) staff to ensure successful delivery of clinical study milestones
Qualifications
University degree or equivalent
4 years experience in clinical research or related field
Experience in project management of global clinical trials
Experience in electronic data capture systems (RAVE, InForm, OC-RDC), clinical trial management systems, and electronic trial master file
Experience in conducting real world evidence is desirable
Competencies
Decision Making
Planning and Organizing
Building Partnerships (Teamwork and Collaboration)
Technical/Professional Knowledge and Skills
Strategic Agility
Leadership and Negotiation
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an Equal Opportunity Employer.
The Position
Responsibilities
Assume the Country Study Lead role in the PDMA studies
Assume Country Study Specialist (CSS) and Study Start-up Specialist (SSUS) roles
Execute all start-up activities prior to site activation on assigned studies, according to regulatory and ethics requirements, Roche standards, study timelines and budget
Provide country-level and site-level oversight activities on global and Affiliate's local clinical trials including but not limited to interventional study, ensuring compliance to Good Clinical Practice (GCP), Roche standard operating procedures (SOP), and local regulations
Work with global study team and Country Study Manager (CSM) to manage and support day to day activities of the study
Create study budget and negotiate contract in compliance with the fair market value (FMV) in the country
Support the non-interventional and investigator initiated studies, in collaboration with the Medical Affairs Team and the Evidence Generation Lead or Real World Data Lead.
Provide leadership and support to the Contract Research Organization (CRO) staff to ensure successful delivery of clinical study milestones
Qualifications
University degree or equivalent
4 years experience in clinical research or related field
Experience in project management of global clinical trials
Experience in electronic data capture systems (RAVE, InForm, OC-RDC), clinical trial management systems, and electronic trial master file
Experience in conducting real world evidence is desirable
Competencies
Decision Making
Planning and Organizing
Building Partnerships (Teamwork and Collaboration)
Technical/Professional Knowledge and Skills
Strategic Agility
Leadership and Negotiation
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an Equal Opportunity Employer.
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Roche
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Roche jobs
Taguig, Metro Manila
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Position co untry study lead recruited by the company Roche at Taguig, Joboko automatically collects the salary of , finds more jobs on Country Study Lead or Roche company in the links above
About the company
Roche jobs
Taguig, Metro Manila