Job description
Job Purpose (State in one sentence the overall objective of the role)
Acts as a central point of communication between Novartis and Investigators for all assigned clinical trial related activities to assure trials are conducted on time and budget while fully GCP, ICH and Novartis SOP compliant
Job Responsibilities:
Acts as a central point of communication between Novartis and Investigators for all assigned clinical trial related activities to assure trials are conducted on time and budget while fully GCP, ICH and Novartis SOP compliant
Job Responsibilities:
Major Activities (Describe main activities)
• Participate in site nomination process; perform evaluation of site capability and make recommendation for inclusion in clinical trial
• Assume ambassadorial role to facilitate communication between sites and Key Novartis line functions to increase value proposition to investigators
• Facilitate preparation and collection of site level documents
• Execute site initiation and training activities including site set up activities
• Perform monitoring visits according to monitoring plan
• Manage site drug supplies
• Resolve site level update of technical systems (ClinAdmin, EDC, OC-RDC etc.)
• Ensure site activities in line with milestones (i.e. startup, recruitment, closeout, etc.)
• Manage recruitment implementing appropriate contingency plans as needed
• Assure continual GCP, ICH and Novartis SOP compliance (Informed consent process, Source data verification, AE and SAE reporting, IN, protocol, drug accountability etc.). Resolve deviations to standard by remedial action and training
• Author study monitoring reports
• Perform data query resolution process (both at Site and with Data Management)
• Execute site closeout activities
• Acts as local (or global) CRA Lead, as assigned
• Coordinate with the global clinical trial team and the CPO colleagues to ensure smooth conduct of the clinical study at the sites
• Preparation of regulatory submission and liaising with the DRA team
• Perform trial feasibilities
• Assist in expanding investigator pool across different TA’s
• Perform budget negotiations if assigned and assist in TCF completion at different milestones.
• Author SOP’s if required
• Participate in site nomination process; perform evaluation of site capability and make recommendation for inclusion in clinical trial
• Assume ambassadorial role to facilitate communication between sites and Key Novartis line functions to increase value proposition to investigators
• Facilitate preparation and collection of site level documents
• Execute site initiation and training activities including site set up activities
• Perform monitoring visits according to monitoring plan
• Manage site drug supplies
• Resolve site level update of technical systems (ClinAdmin, EDC, OC-RDC etc.)
• Ensure site activities in line with milestones (i.e. startup, recruitment, closeout, etc.)
• Manage recruitment implementing appropriate contingency plans as needed
• Assure continual GCP, ICH and Novartis SOP compliance (Informed consent process, Source data verification, AE and SAE reporting, IN, protocol, drug accountability etc.). Resolve deviations to standard by remedial action and training
• Author study monitoring reports
• Perform data query resolution process (both at Site and with Data Management)
• Execute site closeout activities
• Acts as local (or global) CRA Lead, as assigned
• Coordinate with the global clinical trial team and the CPO colleagues to ensure smooth conduct of the clinical study at the sites
• Preparation of regulatory submission and liaising with the DRA team
• Perform trial feasibilities
• Assist in expanding investigator pool across different TA’s
• Perform budget negotiations if assigned and assist in TCF completion at different milestones.
• Author SOP’s if required
Desired Skills and Experience
Key Performance Indicators (Indicate how performance for this role will be measured)
• Deliver high quality data according to agreed timelines demonstrating thorough understanding of international and local regulations and Novartis SOP standards.
• Feedback of internal ICRO colleagues and external (Investigators)
Ideal Background (State the preferred education and experience level)
Education (minimum/desirable): Degree in scientific of healthcare discipline. Master degree preferred
Languages: Fluent in local language(s)
English written and spoken
Experience/Professional requirement:
• Basic medical and business knowledge.
• Desired atleast 1-2 years’ experience in clinical research as CRA and handle global clinical studies.
• Understands and can apply knowledge of clinical trial designs to trial execution.
• Knowledge and experience in international standards (GCP/ICH), international (FDA, EMEA) and local regulations.
• Expertise in communication, managing clinical trials
• Deliver high quality data according to agreed timelines demonstrating thorough understanding of international and local regulations and Novartis SOP standards.
• Feedback of internal ICRO colleagues and external (Investigators)
Ideal Background (State the preferred education and experience level)
Education (minimum/desirable): Degree in scientific of healthcare discipline. Master degree preferred
Languages: Fluent in local language(s)
English written and spoken
Experience/Professional requirement:
• Basic medical and business knowledge.
• Desired atleast 1-2 years’ experience in clinical research as CRA and handle global clinical studies.
• Understands and can apply knowledge of clinical trial designs to trial execution.
• Knowledge and experience in international standards (GCP/ICH), international (FDA, EMEA) and local regulations.
• Expertise in communication, managing clinical trials
Company:
Novartis
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