Synergen Bio Pvt. Ltd – Openings for Clinical Research Associate / Medical Writer

Openings At Synergen Bio Pvt Ltd.
Position : Clinical Research Associate

Vacancies : 04
Qualification : B.Pharm, M.Pharm
Department: Clinical Trial
Experience: 2-3 Years
Clinical Research Associates:
1. Ensure that the rights, safety and well-being of subjects in a clinical trial are respected
2. Identify and select the sites, to conduct the Evaluation visit, Initiation visit, Monitoring and Closure visits
3. Ensure that all adverse events are accurately documented and transmitted
Review of all data collection folders (Case Report Form), comparing them with the original documents (reconciliation)
4. Manage and perform monitoring and site management activities related to clinical trials
5. Perform remote and on-site monitoring & oversight activities
6. Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out
7. Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance
share CV on- career@synergenbio.com, under email subject line mention “Applying for CRA position”

Vacancies for Senior Manager- Clinical Trial.
Vacancies: 02
Experience: 08-10 Years
Qualification: M.Pharm, Phd
Department: Clinical Trial
JD:
• Collaborate with internal stakeholders and KOLs (key opinion leaders) to develop and review study concepts, protocol and study outlines and subsequently driving identified initiatives. Actively contribute to strategic discussions around clinical affairs activities locally and globally for specific product or procedure areas
• Conduct literature searches, including systematic searches to stay abreast of scientific knowledge and to determine the evidence gaps.
• Responsible for the planning and execution of the clinical studies including investigator selection, analysis of potential patient recruitment, creation of study related documents (including protocols, case report forms, Informed consents, Clinical trial agreements), organizing IRB/EC submissions with follow-through to ensure successful outcome. Etc
Interested candidates can share their resumes on: career@synergenbio.com
Under Email subject line please mention “Applying for Senior Manager- Clinical Trial“.

Openings at Synergen Bio Pvt. Ltd.
Position: Medical Writer

Vacancies : 03
Experience 2-3 Years
Qualification : B.Pharm, M.Pharm
JD.
1. Manage the writing, editing and reviewing of diverse regulatory & clinical documents for multiple projects in various stages, including clinical study reports (CSRs), clinical trial synopses, study protocols, investigator brochures, informed consent forms, clinical data summaries, clinical modules, dossiers and other medical/regulatory documents including SOPs.
2. Manage the writing, editing and reviewing of, publications, abstracts, manuscripts, Posters, DSURs, PSURs, PBRER, RMPs, and signal detection reports.
3. Provide input to timelines for completion of clinical documents and ensuring delivery documents to meet the timelines.
4. Review pertinent literature, evaluating its applicability and incorporating the information into clinical documents.
5. Ensure that all clinical documents are produced according to appropriate SOPs, business practices and quality standard.
Interested candidates can share their resume on career@synergenbio.com
Under Email subject line please mention “Applying for Medical Writer Position

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