Clinical Trials Administrator - India

Acm India; Mumbai; On-site; INR 400,000 - 800,000; Full time

Job summary

Rochester Regional Health in Mumbai, India seeks a Clinical Trials Administrator to coordinate trial activities from setup to closeout, ensuring compliance and timely deliverables. You’ll work with sponsors, investigator sites, laboratories, and vendors, supporting LIMS setup, QC, and supply logistics.

The role requires a Master’s degree in Biochemistry/Microbiology/Chemistry and 1–2 years’ CRO/Central Lab experience, with strong communication and data-handling skills.

Qualifications

• Master’s degree in Biochemistry, Microbiology or Chemistry.
• 1–2 years experience in a Central Laboratory or CRO.
• Excellent verbal and written communication skills.
• Computer proficiency; familiarity with relational databases and reporting tools.
• Ability to multi-task and prioritize workload.
• Customer service experience and problem-solving mindset.

Responsibilities

• Coordinate clinical trial activities from setup through closeout.
• Review protocols and assist with protocol setup functions.
• Develop Protocol Test Summary, GLSD, and Investigator Laboratory Manual.
• Support day-to-day study activities and study metrics monitoring.
• Interface with sponsors, CROs, and alliance laboratories for projects.
• Manage study binders, site lists, and LabStar WIN access.

Skills

Verbal communication

Written communication

Multi-tasking

Customer service

Critical thinking

Education

Master’s degree in Biochemistry/Microbiology/Chemistry

Tools

Relational databases

Reporting tools

Job description

Job Title: Clinical Trials AdministratorDepartment: Study SupportLocation: Mumbai, IndiaHours Per Week: 40 hoursSchedule: Days, Monday – FridaySUMMARYThe Clinical Trials Administrator [CTA] is responsible for coordinating clinical trial activities from study set-up through closeout, ensuring accurate documentation, data quality, regulatory compliance, and timely project deliverables. Collaborates with clients, investigator sites, laboratory teams, and vendors to support study operations, LIMS set-up, quality control, and clinical trial supply logistics while maintaining service standards and a positive client experience.RESPONSIBILITIESProject ManagementReview Clinical Trial Protocols and assist with protocol set-up functions as required.Develops the Protocol Test Summary (PTS), Global Laboratory Specification Document (GLSD), Investigator Laboratory Manual and protocol specific operating proceduresSupport day to day project related activities once the study is liveCoordination with Sponsor, CRO & Alliance laboratory for each projectParticipate in study conference calls with clientsTake minutesSummarize actions from the meeting, study metrics / trend monitoringGenerate and customises reports to monitor study metrics / trends (i.e. Action Items, supplies shipped, cancelled tests, etc.)Interface with client, sponsor, CROQuery resolutionDIF follow up with client / site contactsResolving unlabelled samplesAdd history and close action items based on responses from sites / clientsStudy binder managementAssist PM with binder management / file documents in binder (including binders that have been archived)Perform secondary binder QC reviewNotify PM when binder has been finalized and submits the binder to PM for reviewSite list managementAdding, removing, and modifying sites / contacts into LabStar WINSite support / incoming calls / Alert Calls and emailsEnsure that the data cleaning & quality control of all the clinical study documents and records is done during the data lock processSubmit the QC’d documents/project files for review and seek approval from the PMUpon receipt of the approval from the PM forward all project related documents for archival according to the ICH-GCP GuidelinesMaintain a positive study experience by engaging with clients, vendors, co-workers, andmanagement, with a positive attitude and by solving issues/requests in a timely manner per service and metric guidelines, and following SOP’s including escalation, change control, & communicationProject Set-upCoordinates internally to set-up assigned projects in LIMS:Protocol Set-upTest & Visit ScheduleComplete and submit patient report, custom flagging, and requisition request forms RequisitionsKit Order Manager (KOM) setup (including inventory notification to logistics) Site list managementAdding sites / contacts into LabStar WINProviding LabStar Web Access – initial and updatesValidation & QCQC of Protocol set-up summaries in each LIMS environmentQC of requisitions set-up in each environmentQC of Kits set-up in KOM in each environmentValidate the LIMS Protocol Set-upValidation Plan draftingTest CasesQC of Test CasesLogisticsManage inventory of supplies of kit components for phlebotomy kit assembly by liaisoning internally with logistics and with vendors who supply kit componentsLiaison and interface with appointed logistic agency for supply of phlebotomy kits to investigator sitesDraft out logistic documents required to be submitted to logistic agency for transportInterfaces with regional/reference/affiliate laboratory’s CT Specimen Processing, Project and Data Management departments to ensure prompt turnaround of all specimen analysis, lab reports as well as pending lab reportsParticipates and documents Quality Audits and inspections of Clinical Trials as prescribed by departmental policies and regulatory agenciesPerforms duties with a general working knowledge of Regional Regulatory bodies, GCP, GDP, ICH and other pertinent regulations, as pertains to central laboratory functions Actively assist the department director/head and reporting manager in the smooth functioning of the office Ensure that the Team is kept motivated and aligned to the business objective of the organization understands and follows company policies and procedures while always maintaining confidentiality, both inside and outside of the work placeMaintain financial performance of company by executing on job duties as specified and by proactively and continuously bringing to management’s attention ideas to improve productivity, service, quality, cost savings, process improvements, policies & procedures, and utilization of company resourcesImprove job knowledge by in-house, outside work, self-study, and on-line training in addition to industry functions, certifications, publications, and other available training resourcesPerform other duties as assignedThis job description is not intended to be exhaustive. The employee may be required to undertake any other duties that are reasonably required and are commensurate with the skills, experience and level of responsibility of the role.PREFERRED QUALIFICATIONSMaster’s degree in Bio-chemistry, Microbiology or Chemistry.1 to 2 year’s experience in a similar capacity in a Central Laboratory or Contract Research Organisation.Excellent verbal and written communication skills required.Computer proficiency required; familiarity with relational databases and reporting tool strongly preferred.Ability to multi-task and prioritize workload required.Customer Service experience required.Critical thinking and ability to problem-solve.PHYSICAL REQUIREMENTS:Rochester Regional Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, age, disability, predisposing genetic characteristics, marital or familial status, military or veteran status, citizenship or immigration status, or any other characteristic protected by federal, state, or local law.