Clinical Trial Monitoring:
Conduct Quality check of the documents during monitoring, cross-verifying the data recorded, reviewing informed consent form and patient eligibility. In case of any discrepancies, escalate for resolution.
Identification of New Investigators: Identifying new investigators for the trial from different databases and establish contact. Conduct proper feasibility at the site to ensure patients are properly recruited and studies are conducted as per GCP (Good Clinical Practices) and schedule Y.
Budget Negotiations: Negotiating the budget for conducting trials with the sites as per defined range
Post - Marketing Surveillance of approved Products: Preparation of protocol and Case Report Form (CRF)for the marketed product to gather safety information as per regulatory requirement . Undertake CRF validation and submit data to data management team.
Operating Network
Internal : QA, Pharmacovigilence, Medical writing, Data management, Regulatory, Formulation Development and Medico-marketing teams
External : Site Investigators, CRO
Desired Profile Technical Requirements: Understanding of ICH GCP, schedule Y and other regulatory guidelines
Educational Qualifications: MPharm - Pharmacology
Experience Required: 2 years post qualification experience
Key Personal Attributes
- Organized, responsible, persuasive individual with good communication skills
- Good time management skills
- Very good negotiation skills
Experience 2 - 4 Years
Education: M.Pharm
Read More
Conduct Quality check of the documents during monitoring, cross-verifying the data recorded, reviewing informed consent form and patient eligibility. In case of any discrepancies, escalate for resolution.
Identification of New Investigators: Identifying new investigators for the trial from different databases and establish contact. Conduct proper feasibility at the site to ensure patients are properly recruited and studies are conducted as per GCP (Good Clinical Practices) and schedule Y.
Budget Negotiations: Negotiating the budget for conducting trials with the sites as per defined range
Post - Marketing Surveillance of approved Products: Preparation of protocol and Case Report Form (CRF)for the marketed product to gather safety information as per regulatory requirement . Undertake CRF validation and submit data to data management team.
Operating Network
Internal : QA, Pharmacovigilence, Medical writing, Data management, Regulatory, Formulation Development and Medico-marketing teams
External : Site Investigators, CRO
Desired Profile Technical Requirements: Understanding of ICH GCP, schedule Y and other regulatory guidelines
Educational Qualifications: MPharm - Pharmacology
Experience Required: 2 years post qualification experience
Key Personal Attributes
- Organized, responsible, persuasive individual with good communication skills
- Good time management skills
- Very good negotiation skills
Experience 2 - 4 Years
Education: M.Pharm
Read More
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