PATH is the leader in global health innovation. An international nonprofit organization, we save lives and improve health, especially among women and children. We accelerate innovation across five platforms—vaccines, drugs, diagnostics, devices, and system and service innovations—that harness our entrepreneurial insight, scientific and public health expertise, and passion for health equity. By mobilizing partners around the world, we take innovation to scale, working alongside countries primarily in Africa and Asia to tackle their greatest health needs. Together, we deliver measurable results that disrupt the cycle of poor health.
Post : Clinical Trials Assistant
Job Description
- Serve as the primary medical writing representative on assigned projects and closely collaborate with team members and external stakeholders.
- Prepare/manage the writing, editing and reviewing of diverse regulatory & clinical documents including clinical study reports (CSRs), study protocols, informed consent forms, and other medical/regulatory documents.
- Manage the quality, accuracy, compliance with internal & external standards and the timely production of English-language documents.
- Prepare training materials and ensure quality of training materials.
- Follow-up with study site, which may include initial screening of potential study sites, coordination of site recruitment questionnaires, and compilation of data for review by the clinical study lead, or designee. Be familiar with and work in accordance with Schedule Y, ICMR guidelines, Good Clinical Practices and ICH guidelines.
- Perform literature searches/reviews as necessary to obtain background information for development of documents
- Act as a team player to take responsibilities as and when provided by PL/Supervisor.
- Participate in external or internal meetings as required.
- Establish and maintain professional relationships (in person, by phone and/or email) with clinical investigators, study staff, and partners as necessary to support clinical studies and other project related work. Prepare, handle, distribute, file, and archive documentation and reports.
- Perform administrative tasks to support team members with project execution as needed.
Required Skills
1.Ability to understand and interpret data/information and its practical application
2.Excellent written/oral communication skills
3. Excellent scientific writing and ability to adapt style & content for different target audiences
4.Excellent technical editing and QC skills
5. Strong understanding of pharmaceutical development, clinical research, study design, biostatistics, the regulatory environment, and medical terminology
6. Experience working in a matrix team environment
7.Experience with budget and vendor management
8.Experience with training or managing staff
9.Computer skills to include MS Office, Visio
10. Ability to search and scan various internal & external databases, e.g. PubMed
11. Knowledge of pharmacovigilance/drug safety or software development will be added advantage
Required Experience
Master’s degree in life sciences, pharmacy, or equivalent health experience with at least 3 years’ experience in clinical research and/or medical writing in biotech or pharmaceutical company.
Additional Information:
Experience : 3 years
Qualification : Master’s degree in life sciences
Location : Delhi
Industry Type : Pharma / Biotech / Clinical Research
Last date : 10th August, 2016
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