Clinical Trials Documentation Specialist
1 day ago
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 reviewed correctly in the eTMF system.
Additional responsibilities include maintaining the eTMF in a state of audit readiness by performing visual quality checks on e-documents before they are released. This includes ensuring clarity and readability and conducting audit-ready checks on each document uploaded to ensure it is contextually accurate.
The Senior TMF Associate will also process and track essential artifacts throughout all phases of the study in alignment with company SOPs, sponsor SOPs, Good Clinical Practice (GCP), and International Council for Harmonisation (ICH) guidelines.
Key qualifications for this position include a Bachelor's Degree in Life Sciences, Business, or a related field, along with a minimum of 3 to 6 years of experience in a clinical research environment. The ideal candidate will have a solid understanding of clinical document management and eTMF processes, as well as strong knowledge of GCP, ICH guidelines, and regulatory/clinical document requirements.
Preferred qualifications include an advanced degree and additional experience in clinical electronic systems and eTMF platforms.
Travel is minimal, less than 10% for Sponsor Kick-Off Meetings, Client Meetings, or as requested.
",-
Expert Clinical Documentation Specialist
13 hours ago
Mumbai, Maharashtra, India beBeeClinical Full time ₹ 21,90,000 - ₹ 2,43,10,000Job 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...
-
Clinical Documentation Specialist
24 hours ago
Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 18,00,000 - ₹ 20,00,000Job 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...
-
Biologics Regulatory Affairs Specialist
1 day ago
Mumbai, Maharashtra, India beBeeBiologics Full time ₹ 1,50,00,000 - ₹ 2,00,00,000Job Title:Biologics Regulatory Affairs Specialist (Clinical Trials)About the Role:We are seeking a skilled Biologics Regulatory Affairs Specialist to oversee the regulatory aspects of our clinical trials for EU and US markets.The ideal candidate will have hands-on experience in developing biosimilar clinical development strategies, clinical trials, and...
-
Mumbai, Maharashtra, India USV PRIVATE LIMITED Full timeAbout USV Private Limited:USV, a top-15 pharmaceutical company in India, excels in the diabetes and cardio sectors and has presence in over 65 countries.Function: BiologicsPosition: Asst Manager / Manager - Regulatory Affairs (Clinical Trials) For EU and US.Job Location: Govandi (East ), Mumbai (1st, 3rd, 5th Saturday working, 2nd and 4th Saturday...
-
Mumbai, Maharashtra, India USV PRIVATE LIMITED Full timeAbout USV Private Limited:USV, a top-15 pharmaceutical company in India, excels in the diabetes and cardio sectors and has presence in over 65 countries.Function: BiologicsPosition: Asst Manager / Manager - Regulatory Affairs (Clinical Trials) For EU and US.Job Location: Govandi (East ), Mumbai (1st, 3rd, 5th Saturday working, 2nd and 4th Saturday...
-
Mumbai, Maharashtra, India USV PRIVATE LIMITED Full timeAbout USV Private Limited: USV, a top-15 pharmaceutical company in India, excels in the diabetes and cardio sectors and has presence in over 65 countries. Function: Biologics Position: Asst Manager / Manager - Regulatory Affairs (Clinical Trials) For EU and US. Job Location: Govandi (East ), Mumbai (1st, 3rd, 5th Saturday working, 2nd and 4th Saturday off))...
-
Advanced SAS Programmer for Clinical Trials
3 days ago
Mumbai, Maharashtra, India beBeeClinical Full time ₹ 18,33,628 - ₹ 24,35,043As a Senior Statistical Programmer, you will be dedicated to supporting clinical trials in the pharmaceutical industry.
-
Senior Data Analyst
3 days ago
Mumbai, Maharashtra, India beBeeStatistical Full time ₹ 1,20,00,000 - ₹ 1,50,00,000Statistical ProgrammerAbout the Role:We are seeking an experienced Statistical Programmer to join our data analysis team. The successful candidate will be responsible for developing and maintaining R programs for generating CDISC SDTM and ADaM datasets and tables, listings, and figures in accordance with clinical trial data requirements.Main...
-
Clinical Programmer
2 days ago
Mumbai, Maharashtra, India Novartis Full timeSummary -Responsible to support all statistical programming data review reporting and analytics development aspects of assigned studies or project-level activities Major accountabilities 1 Produce and track reports for various line functions within Global Drug Development used for ongoing monitoring of clinical data 2 Provide understandable and...
-
Senior Clinical Programmer
2 days ago
Mumbai, Maharashtra, India Novartis Full timeSummary Participate in the full lifecycle of producing key data and or reports in support of data review reporting development including evaluation of requirements design specifications interface to programmers report programming coordinate validation and rollout activities along with providing quantitative analytical support These tasks are to be...
