OneMain Financial Jobs

Job Title:

Clinical Trial Assistant

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.

YOUR TASKS AND RESPONSIBILITIES:

1. Administrative & Documentation Support

• Maintain, update, and organize Trial Master File (TMF) and Investigator Site File (ISF)

• Ensure essential documents meet ICH-GCP, regulatory, and sponsor requirements

• Track and manage study documents, versions, and approvals

• To update and maintain all study related trackers.

1. Study Coordination

• Assist the clinical operations team in planning, initiating, executing, and closing clinical studies

• Support Clinical Research Associates (CRAs) with site management tasks

• Help with study tracking (enrolment status, visit schedules, monitoring reports, etc.)

• Assist in tracking invoice generation and payment process for all sites, clinical studies, ECs, data management vendors, etc. and maintain respective payment trackers

• Perform vendor code generation and tracking of vendors.

1. Communication & Liaison

• Act as a communication link between study sites, CRAs, project managers, and vendors

• Coordinate meetings, teleconferences, and training sessions

• Draft and circulate meeting agendas, minutes, and follow-up action items.

1. Regulatory & Compliance Support

• Assist in preparing documents for ethics committee and regulatory submissions as applicable

• Ensure compliance with SOPs, protocols, and regulatory guidelines

• Track site-level regulatory documents, approvals, and expirations

1. Data & System Management

• Enter and update trial data in relevant trackers and other study management systems (as applicable)

• Perform QC checks on documents and data entries .

• Support query resolution by coordinating with sites and data management teams 6. Logistics & Study

• Supplies. Track and manage study supplies such as study documents, lab kits, IP shipment documents, etc. Coordinate distribution of trial materials to study sites

1. Study Documentation & Reporting

• Assist in preparing status reports, trackers, logs, and summaries

• Maintain study dashboards (screening logs, subject trackers, monitoring schedules)

• Support audit and inspection readiness activities

1. Vendor & Site Support

• Support vendor coordination (labs, couriers, central services)

• Help sites with document submissions, training materials, and study-related queries.

1. Vendor & Site Support

• Support vendor coordination (labs, couriers, central services)

• Help sites with document submissions, training materials, and study-related queries

1. Quality & Audit Readiness

• Assist with internal and external audits (if applicable)

• Ensure documents are audit-ready and up-to-date

• Track and support corrective and preventive actions (CAPA) when required

1. General Administrative Tasks

• Manage study-related correspondence and filing

• Support project managers with operational activities as needed RELATED EXPERIENCE REQUIREMENT

• Relevant experience of 1-2 years in the field of Clinical Research

• 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

• Sound analytical skills , Attention to detail ,Sense of urgency & desire to excel

• Intellectual curiosity , Result oriented and performance driven, Sound interpersonal & communication skills to effectively interact with a broad range of audience.

PHYSICAL REQUIREMENTS/WORKING CONDITIONS The role is office based.

Job Requirements

Educational Qualification

Minimum qualification requirement is to have 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

1-2 years in Clinical Research/Clinical Research Coordinator (Hospitals)

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.