Experience: Min. 3 Years
Preferred: Healthcare Industry
CTC: As per industry standards.
Key Responsibilities:
- Will develop the outline trial protocols and manage Investigational Product (IP) and trial materials.
- Will manage multiple aspects of subjects’ welfare.
- project coordination with CRO’s, carry monitoring visit at CRO to manage study logistics.
- Will conduct regular site visits, generate, and distribute internal and external newsletters, prepare final reports and liaison with interested parties regarding all trial aspects.
- Identify, evaluate, and establish trial sites, and ensure the completion of trial.
- To train site staff on therapeutic areas, protocol requirements, proper source documentation and case report form completion.
- Liaison with ethics committee regarding rights, safety, and well-being of trial subjects.
- Overseeing and documenting IP dispensing, inventory, and reconciliation.
- Protecting subjects’ confidentiality, updating their information, and verifying IP has been dispensed and administered according to the protocol.
- Conducting regular site visits, coordinating project meetings, and writing visit reports.
- Implementing action plans for sites not meeting expectations.
- Liaising with regulatory authorities.
- Ensuring compliance with SOPs and local regulations, and ICH and GCP guidelines.
- Other tasks and responsibilities as needed.
- Collaborative approach of working with Sales & Marketing team for initiating projects.
Additional Skills:
- Bachelor’s degree in Biological Science or a related field
- Computer proficiency
- Excellent numerical, written, and verbal communication skills
- Excellent research skills and attention to detail
- Sharp analytical and critical thinking
