Job Description
Conducts feasibility, screens potential Investigators & networks to evaluate capabilities for conducting clinical trials Conducts site selection for potential sites to evaluate capabilities for conducting clinical trials and recommends accordingly Liaisons between NVS & sites ensuring successful collaboration, meeting NVS expectation on milestones & deliveries Manages assigned study sites & networks (if applicable), conducts phase I-IV protocols as per monitoring plan & NVS procedures Facilitates preparation & collection of site & country level documents Performs Site Initiation Visit, ensures site personnel is fully trained on all trial related aspects Performs continuous training for amendments & new site personnel as required Retrains site personnel as required Implements site management activities ensuring compliance to protocol, GCP, global & local regulations & processes to secure data integrity & patient safety Continuously updates all electronic systems relevant to perform job functions Ensures study milestones for sites responsible are met as planned Performs Site Closeout activities per SOPs & applicable regulations to ensure site is aware of any follow up activity & archiving requirements Attends onboarding, disease indication & project specific training & general CRA training as required Documents monitoring activities following NVS standards Collaborates with CRA Group Head/CSM to ensure recruitment plans & executes contingency plans Participates from audit organization & inspection readiness activities for monitoring & site related activities & ensures implementation of corrective actions within timelines Monitors studies as per current legislations, ICH/GCP & NVS standards Ensures timely delivery of high quality & reliable data of monitored sites to support goals of TM as defined by TM (ADIS, DBL) Identifies issues at sites; resolves issues & escalates as appropriate Collaborates with internal stakeholders & site personnel to manage data query resolution process ensuring timely, accurate data entry Collects essential documents from site & accountable to keep TMF(s) current Participates in multi-disciplinary teams in CPO & globally to evaluate & implement process improvement Supports implementation of innovative processes & technologies Negotiates investigator remuneration; prepares financial contracts between NVS & investigational sites & investigators Ensures payments are appropriately triggered to investigational sites
Candidate Profile
Degree in scientific or healthcare discipline. Fluent in both written and spoken English, local language as needed in clusters/countries
• Minimum of 3 years experience in site monitoring
• Excellent knowledge of the drug development process specifically clinical trial/research • Knowledge of international standards (GCP/ICH, FDA, EMEA)
• Ability to manage multiple priorities and manage time efficiently.
• Basic project management skills to support in CSM activities.
Degree in scientific or healthcare discipline. Fluent in both written and spoken English, local language as needed in clusters/countries
• Minimum of 3 years experience in site monitoring
• Excellent knowledge of the drug development process specifically clinical trial/research • Knowledge of international standards (GCP/ICH, FDA, EMEA)
• Ability to manage multiple priorities and manage time efficiently.
• Basic project management skills to support in CSM activities.
Additional Information
Experience : 3 years
Qualification : M.Sc, B.Sc
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D
End Date : 10th May, 2019
Experience : 3 years
Qualification : M.Sc, B.Sc
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D
End Date : 10th May, 2019
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