Sun Pharmaceutical Industries Limited is taking this opportunity to balance employment and the medications to the world. We are hereby inviting candidates who are interested to join India’s No. 1 company in Pharmaceutical sector.
Post : Clinical Research Associate
Job Description
In-House Managed Studies
Site feasibility, potential investigator identification and development of study budgets for each study
Finalization of investigators, sites and execution of CDA and study related contracts
Plan and conduct Investigator’s Meeting if needed
Preparation and submission of study documents for EC permission for respective study across centers
Work with R&D teams and facilitate IP procurement and ensuring streamlined auditable trial supplies to respective sites
Overseeing & documenting IP dispensing, inventory management & reconciliation
Site initiation, site monitoring and site close-out activities
Investigator and site personnel training on Study protocol, procedures and GCP principles
Ensure timely recruitment of trial participants and subsequent efficient and effective data management
Ensure regular site monitoring visits as per plan, source data verification, informed consent form review, case report form review, investigational drug accountability, and adverse event review for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies, and provides remedial training and/or initiates corrective action as required
Ensure timely reporting of SAEs, SUSARs and reporting of SAEs to all sites and investigators in alignment with regulations and Sun’s PV policies
Coordinate project meetings and preparation of monitoring visit reports
Risk identification, analysis and CAPA for sites not meeting expectations as per plan
Co-ordinate with in-house or CRO partners for data management, statistical analysis & statistical analysis report
Lead & guide data query resolutions in coordination with sites and data management team • Management of the trial budget(s) and maintenance of the accounts
Candidate Profile
> 4–5 years’ experience in a CRO/Pharma/Biotech organization in clinical operations
Experience in handling large clinical trials with multiple sites for different therapeutic areas
Thorough Knowledge & experience of remote and risk-based monitoring will be of added value
Must have experience in handling audits & inspections
Training in clinical trial methodologies, research design and ICH – GCP
Thorough knowledge of GCP guidelines, ICMR guidelines 2017 and Drugs and Cosmetic Act regulations pertaining to clinical trials
Strong academic record with strength in research with knowledge of research methodologies
Experience of working in matrix business environments preferred
Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards
Competency Requirement
integrity driven decision making skills
Sound functional knowledge in clinical research and operations
Collaboration and teaming with ability to work in a matrix environment
Strategic thinking & sound analytical skills
Big picture orientation with attention to detail
Sense of urgency & desire to excel
Intellectual curiosity
Self-awareness and adaptability to work in a matrix environment
Result oriented and performance driven
Excellent interpersonal & communication skills to effectively interact with a broad range of audience
PHYSICAL REQUIREMENTS/WORKING CONDITIONS
The role is majority office based but will involve an average 8 to 10 days of travel outside Mumbai.
Additional Information
Experience : 4–5 years
Location : Sun House – Corporate Office Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 25th September 2024