Openings for Executive / Sr. Executive – Clinical Development at Aurigene:
Position : Executive / Sr. Executive – Clinical Development
Location : Bangalore
Desired Profile : Bachelor’s or higher degree in life sciences, nursing, medical or any other relevant discipline with at least 2-4 years of experience in working as a CRA
• 2-4 years of prior operational experience in coordinating & managing clinical trials in India
• High level understanding of the clinical study implementation process with experience in oncology and/or inflammation.
• Must be highly organized and be a good problem solver with solid understanding of data collection methods
• Capable of interacting effectively with scientists and managers within the organization as well as with CRCs (Clinical Research Coordinators), PIs and Co-PIs at clinical sites
• Efficient in monitoring clinical data both remotely and on site visit
• Strong understanding of GCP, CFR and ICH guidelines with good understanding of the regulatory (e.g., DCGI, FDA) auditing process
• Knowledge and qualification with international standards (e.g. GCP, CDISC, etc.), company tools (including data management systems), processes and SOPs
• Experience in managing meetings with the clinical trial teams, experts, investigators etc)
• Excellent oral and written communication skills
Job Description, Key Skills & Competencies:
• Monitors clinical sites in India and nearby countries
• Oversees operational components of clinical trials at each of clinical sites
• Develops and maintains the onsite Trial Master File (TMF), in coordination with the site CRC, for each of the sites
• Engages sites for patient enrolment to ensure recruitment is on time
• Participates in Investigator’s Meetings
• Implements clinical trial operational plans and ensures that clinical trials are conducted in a timely fashion and site is compliant with SOPs, GCP, and regulatory guidelines
• Participates in patient identification activities and the development of patient recruitment plans and back-up plans
• Identifies, recruits, and approves clinical investigators in collaboration with Medical Monitor and Clinical Operations leadership
• Interacts with different vendors associated with the clinical trial
• Reviews invoices from sites for accuracy compared to budgets and Clinical Trial Agreement (CTA)
• Ensures that all monitoring activities and processes are complete, including training of site personnel
Company Overview Please visit http://www.aurigene.com/careers
Apply Now
Please send your profile to Veerendra Patil,
veerendra_p@aurigene.com , with a copy to careers@aurigene.com
