Clinical Document Specialist

Job Title: Regulatory Documentation SpecialistJob Summary:To write, review and manage the production of high quality clinical and safety documentation for submission to regulatory authorities in support of marketing applications.Main Responsibilities:• Author, review and independently manage high quality clinical and safety documents, including Clinical...

Job Description:As a Clinical Document Authoring specialist, you will be responsible for crafting and analyzing clinical trial documents. Your expertise will ensure the accuracy and clarity of these critical documents.The ideal candidate will have in-depth knowledge of clinical trial phases, study design, and drug development. You will work with key clinical...

Job Description">We are seeking an experienced Clinical Document Management Specialist to join our team. In this role, you will be responsible for managing clinical documents under the eTMF system, ensuring they are classified and reviewed correctly.You will also ensure that the eTMF is maintained in a state of audit readiness by performing visual quality...

Senior TMF Associate Job Summary">The Senior TMF Associate plays a key role in ensuring the smooth management of clinical trials documentation.This individual will be responsible for managing document classification, review, and deletion processes under Smart Inbox and ARC. They will ensure that all clinical study documents are uploaded, classified, and...

Job Title:Clinical Content SpecialistDescription:The ideal candidate will be responsible for preparing and reviewing clinical documents for regulatory submissions across various therapeutic areas. This includes but is not limited to Protocols, Clinical Study Pharmacology Reports, Clinical Study Reports, Narratives, Post Approval Documents, Clinical Summaries...

Job Title:Clinical Quality Assurance Compliance & trainingExperience: 5 plus yearsLocation:MumbaiType:Full-timeExperience Level:[Senior] Manager/Senior ManagerDepartment:Clinical Research DepartmentPurpose of this Role:This role will be responsible for oversight on end-to-end clinical trial activities from quality perspective. This role will be accountable...

Job Title: Clinical Quality Assurance Compliance & training Experience : 5 plus years Location: Mumbai Type: Full-time Experience Level: (Senior) Manager/Senior Manager Department: Clinical Research Department Purpose of this Role: This role will be responsible for oversight on end-to-end clinical trial activities from quality...

Hiring for Clinical Science Lead - Medical Monitoring for a leading Pharma clientMumbaiTASKS AND RESPONSIBILITIESLead the clinical research medical science related activities such as preparation of synopsis, protocol, Clinical Study Report (CSR) and present the proposals in subjects expert committee (SEC) regulatory meetingCollaborate with clinicians, KOL to...

Position Title: Sr. Manager/ Manager Clinical Quality Compliance and TrainingYOUR TASKS AND RESPONSIBILITIES: This role will be responsible for oversight on end-to-end clinical trial activities from quality perspective.This role will be accountable for Quality Compliance (QC) activities of Clinical Trial Medical Science team and Operations team, Clinical...

Collaborate with clinicians, KOL to get the feedback and inputs on clinical trial design, comparator and endpoints of the study to finalize synopsis.Lead the clinical research medical science related activities such as preparation of synopsis, protocol, Clinical Study Report (CSR) and present the proposals in subjects expert committee (SEC) regulatory...