SIRO Clinpharm is one of the leading Global Clinical Research Organizations (CROs), offering full scope services conducting clinical trials in the Pharmaceutical, Biotechnology and Medical Devices sectors in compliance with International Standards. We are headquartered in India having global presence in USA, Israel and in Europe at Germany, Czech Republic, Greece, Estonia, Romania, Spain and France.
Post: Senior Medical Writer, Clinical Research Associate
Senior Medical Writer
Development of Clinical Study Reports, Protocols, ICFs, IBs, Safety Reports, Efficacy Reports, Narratives, Web synopsis and other regulatory submission documents
Performing quality check review of above documents
Disseminate the knowledge gained at regular intervals with the team across the projects
Ensuring that timelines for deliverables are met and that they comply with established performance metrics.
Lead priority setting, Resource planning and allocation for various projects based on their training status and experience level to ensure adequate assignment of resource to projects.
Develop and implement appropriate management control systems to ensure quality deliverables and adherence to process compliance, maintaining & tracking performance metrics for the reportees.
Team motivation, mentoring & grooming the study team/ reportees to ensure effective service delivery across projects and achieve targets & goals set across projects.
Creation of a database of competencies and aspirations within the team.
Providing suggestions for process improvements resulting in savings in time, cost, and quality
Developing and strengthening relationships with sponsors.
Analyzing quality failure issues & identifying the corresponding system/process changes / training needs.
Ensuring timely reporting of deliverables & prompt issue escalation to the Line Manager.
The incumbent should be MBBS, BHMS, BAMS, MD, Ph.D. or Post graduate in Pharmacy or life sciences with at least 4-5 years of experience in Medical Writing with ability to interpret and analyze data.
Post: Clinical Research Associate
Perform study site qualification visits, participate/conduct investigator’s meeting and site initiation visits in coordination with the project manager and/or medical monitor
To ensure all assigned studies follow SIRO/applicable SOPs, GCP and local regulations. Ensure regulatory documents are available, complete and current and submitted as per timelines.
To identify, define, coordinate and conduct site study training. Perform regular monitoring visits to site, prepare monitoring reports and maintain audit readiness at the site level.
Responsible for recruitment and propose alternative solutions if the predefined objectives are not met, either in the terms of patient number or timelines.
To resolve all data queries or other study related queries from the site within timeframe.
Conduct site close out and assure appropriate archival of controlled documents.
The incumbent should be Doctorate/Master’s/Bachelors Degree in Science with minimum two years of experience on Phase I/II/III trials is must in the capacity of CRA either in CRO or a bio-pharmaceutical company. Basic understanding of the drug development process and understanding of clinical research process and ICH GCP is must.
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