Tracking Code 6069
Location: New Delhi
Job Description
This role is contingent upon funding.
PATH is an international organization that
drives transformative innovation to 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.
The project
called Clinical Development Training
Program (CDTP) aims to strengthen the clinical research capacity in India.
The project will enable trainings and provide resources to meet the ultimate
global need for safe, effective, and affordable medicines by establishing
advanced resource centers at premier research institutions in India. The
program intends to provide sustainable support in major areas of clinical
research, viz. pharmacovigilance, advance data management and training, and
ethics.
The project
called Visceral Leishmaniasis (VL) Program aims to support the national
pharmacovigilance system for drugs used for VL in Nepal and Bangladesh, and
alsoregistration and preparation for adoption of Paromomycin IM injection by
Government of these countries.
PATH is seeking a Program
Officer with clinical research and scientific writing experience for
Clinical Research, Visceral Leishmaniasis project, and Clinical Development
Training Program in New Delhi. As
a core member of the project’s operations team, the incumbent will be
responsible for supporting all aspects of assigned clinical research projects
and the CDTP project under the overall
guidance of the Project Team Leader. Specific responsibilities include:
- Responsible for writing documents like clinical study protocol, informed consent documents, study and project reports and manuals, and proposal development.
- Responsible for supporting a moderate to large team or multiple small size protocols with minimal to no supervision.
- Perform monitoring visits for observational studies, as required.
- Build relationships with investigators and site staff.
- Responsible for the completeness and quality of the on-site files, respond to site issue alerted from sites.
- Update all relevant tracking systems on an ongoing basis.
- Provide support for management and execution of PATH’s clinical development training program in consultation with the Team Leader, Clinical Research and Development.
- Support for executing this project by ensuring stable, strategic partnerships with government agencies, public health partners and academic institutions.
Required Skills
- Knowledge of clinical study management, and Indian regulatory experience.
- Proficient in the use of Microsoft Office.
- Excellent oral and written communication in English.
- Interpersonal skills and ability to work in a team and with external stakeholders/partners.
- Ability to travel approximately 25%.
- Exceptional interpersonal and relationship-building competencies coupled with excellent medical writing skills.
Required Experience
MBBS with
five years’ experience or MD with three years of experience with experience in
functions like clinical operations or medical writing either at a
pharmaceutical company or clinical research organization. Understanding of
Pharmacovigilance as a subject will be an added advantage. The ideal candidate
for this role will have demonstrable experience in the area of clinical
research.
For Apply Please Visit : https://path.silkroad.com/epostings/index.cfm?fuseaction=app.jobinfo&jobid=300331&company_id=15780&version=1&source=ONLINE&jobOwner=988961&aid=1
Must have legal authorization to work
in India.
PATH is dedicated to diversity and is
an equal opportunity employer.
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