Job title:Manager clinical Research(teva)

Qualifications: MBBS/MD

Experience:7 years

Job profile:

Qualifications: Qualified by education, experience, and training to oversee the study's proper conduct.

Before Study Start:

• Comply with applicable regulations, complete required forms, and follow GCP, protocol, Lotus SOPs, and ethical principles from the Declaration of Helsinki.

• Review and understand the Investigational Brochure (IB) or relevant drug information before study initiation.

• Review and provide timely feedback on the protocol, CRF, ICD, and related documents (dosing, contraindications, warnings, adverse events, drug interactions).

• Obtain ethics committee approval and clarify any issues raised by the EC.

• Ensure study personnel are aware of their responsibilities and trained on the protocol and study plan.

Responsibilities:

• Oversee study-related activities, ensuring timely and accurate execution.

• Ensure the protocol and informed consent are scientifically sound, clear, and detailed.

• Submit study documents to the Ethics Committee (EC) for approval and ensure all conditions are met before study initiation.

• Coordinate screening activities and assess subject eligibility based on medical history, physical exams, radiology, ECG, and lab results.

• Maintain screening records per GCP and regulatory requirements and refer subjects with clinically significant issues for further medical evaluation.