Job Information
Sun Pharmaceuticals, Inc Clinical Research Associate in India
Job Title:
Clinical Research Associate
Business Unit:
Medical Affairs & Clinical Research
Location:
Mumbai
At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
Are You Ready to Create Your Own Sunshine?
As you enter the Sun Pharma world, youll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each others journeys.
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 Pharmas 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 investigator.
Ensure training of CROs on Suns 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 Investigators 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 Suns 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 accounts
Job Requirements
Educational Qualification
Bachelor's or Master's degree in a field related to Science, Healthcare, Clinical Research or Life Sciences like Biology, Pharmacology, Nursing, or a related discipline, and/or Post-graduate Diploma in Clinical Research.
Experience
35 years of 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.
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.
Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.