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5.0 - 8.0 years
6 - 10 Lacs
ahmedabad
Remote
Position: Medical Writer I / Senior Medical Writer Experience Required: 6 to 8 years (CRO preferred / Pharma) Qualification: M. Pharm (Pharmacology) / Pharm D Location: Remote (Work from Home) Job Type: Full-time, Remote Key Responsibilities (Must-Have Skills) - Independently prepare, review, and finalize Protocols - Concept Sheets - Investigators Brochure (IB) - Informed Consent Forms (ICF) - Case Report Forms (CRF) - Ensure compliance with regulatory requirements Nice-to-Have Skills - Module 2 (CTD) Documents - Regulatory briefing documents - Manuscripts and publications - Scientific presentations / posters - Experience with global teams Role & responsibilities Act as the primary point of ...
Posted 1 week ago
3.0 - 7.0 years
5 - 9 Lacs
hyderabad
Work from Office
Independently perform study setup activities including CRF design, database structure design, annotation, DMP, CRF completion guidelines, Data Validation Manual (DVM) creation and/or approval, data entry screen design and testing, validation check testing and approval, etc. Serve as a primary or backup resource for issues pertaining to data management Assist other Clinical Data Managers or Project Managers with management of timelines and communication as they pertain to data management activities Work closely with all levels of Clinical Data Analysts assigned to the studies to ensure completion of study tasks in a timely manner with quality Assist with data listing review, query management ...
Posted 1 month ago
4.0 - 5.0 years
6 - 15 Lacs
ahmedabad
Work from Office
- Collaborate with project managers to define scope, timelines, and deliverables - Ensure timely and effective execution of clinical trial software solution projects - Provide consulting for CTMS platform implementation, configuration Required Candidate profile - Advise on solution architecture, workflows, and usability enhancements in CTM systems - Validate the alignment of software features with clinical workflows and regulatory requirements Perks and benefits -GPA &term Insurance -5 days week -open to discuss
Posted 1 month ago
3.0 - 7.0 years
1 - 1 Lacs
hyderabad
Work from Office
• Provide training On End To End TMF Process • Process TMF documents with good documentation practices, indexing requirements, and TMF readiness criteria. • 3–5 years of experience in TMF management, clinical documentation, or records management. Required Candidate profile • Hands-on experience with eTMF systems and Softwares. • Able To Give Hands-on expertise with leading eTMF systems. • Interested Directly Contact Sneha - 9133469786
Posted 1 month ago
3.0 - 4.0 years
7 - 9 Lacs
chennai, bengaluru, thiruvananthapuram
Work from Office
Role & responsibilities Excellent functional knowledge of CRF design tools and one clinical data management system, with basic understanding of another CDMS. • Ability to plan and design CDMS components directly from interpretation of medium complexity clinical trial protocols. Business Expertise: • Acts as the primary point of contact during study build for assigned projects for design related questions by the project team. • Read, ensure understanding and adhere to the study protocol, contract and scope of work for all task during set-up, maintenance and close-out of the study. • Tracks and keeps functional management and those responsible for project management informed of any issues that...
Posted 2 months ago
5.0 - 10.0 years
15 - 30 Lacs
bengaluru, mumbai (all areas)
Work from Office
Openings for Statistical Programmer - Band - 4/5/6 Salary Up-to - 30 LPA + VAriables Any Grad / PG with - 5 yrs of exp Clinical SAS , Creation & Validation of ISS & ISE reports Development of sas macros etc Call @ WhatsApp- Shubhani -8595849767
Posted 3 months ago
7.0 - 12.0 years
6 - 10 Lacs
Bengaluru
Work from Office
Job Purpose: Data Analyst, Clinical Data Management. Key Responsibilities: • Responsible for execution of data management activities for all clinical projects. • Reviewing data management plan. • Performing quality checks for the data points. • Raising queries to clarify the discrepancy. • Updating the resolved queries in database for paper studies. • Initiating the process of data quality reviews. • Provide inputs for Case Report Form (CRF) designing. • Responsible for the quality of data that is being collected and processed. • Any other responsibilities assigned by the organization from time to time. • Possess the knowledge and exposure to environment, health, and safety (EHS) practices •...
Posted 6 months ago
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