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Premium Employer

Sun Pharmaceutical Industries

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4.0

based on 5.8k Reviews

Top Rated Pharma Company - 2024

1 Sun Pharmaceutical Industries Team Member Job

Team Member - Clinical Research

SUN PHARMA

4.0

based on 5.8k Reviews

4-5 years

Mumbai

1 vacancy

Team Member - Clinical Research

Sun Pharmaceutical Industries

posted 22d ago

Job Role Insights

Flexible timing

Key skills for the job

Cron Pharmacy Pharmacovigilance Clinical Research Clinical Data Management Recruitment

+ 3 more

Job Description

YOUR TASKS AND RESPONSIBILITIES:

CRO Managed Studies:

Manage Contract Research Organization (CRO) for effective execution of interventional, non-interventional and epidemiological studies
Identify potential investigators and sites for clinical studies in collaboration with CROs and India Medical Affairs team
Support in preparation and review of clinical trial documents for Ethics committee (EC) & Drugs Controller General of India (DCGI) and/or other regulatory submission (as applicable)
Vendor management as per Sun Pharma s applicable policies & procedures
Coordination with investigator and sites for executing clinical study agreements & financial agreements in co-ordination with CRO
Coordinate with internal stakeholders (Medical, Regulatory, Quality Assurance etc. ) for timely regulatory submissions
Plan Investigational Product and other related trial material requisition, procurement, and dispatch
Ensure timely reporting of Serious Adverse Events (SAEs), Suspected Unexpected Serious Adverse Reactions (SUSAR) to regulatory authorities and reporting of SAEs to all sites and investigators
Ensure training of CROs on Sun s Pharmacovigilance (PV) practices

In-House Managed Studies:

Site feasibility, potential investigator identification and development of study budgets for each study
Finalization of investigators, sites and execution of Confidential Disclosure Agreement (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 Investigational Product (IP) procurement and ensuring streamlined auditable trial supplies to respective sites
Overseeing & documenting IP dispensing, inventory management & reconciliation
Site selection, 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; identify deficiencies and discrepancies, and provide remedial training and/or initiate 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 Corrective and Preventive Action (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 account

WHO YOU ARE:

4-5 years experience in a CRO/Pharma/Biotech organization in clinical trial 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 New Drugs and Clinical Trial Rules, 2019, 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