End to end project management of all phases of clinical studies for products under development stage and departmental activities in compliance with organization policies. Active involvement within cross functional stakeholders on shared goals. Study planning and management and execution and oversight and risk assessment and mitigation against project deliverables to ensure compliance. CRO Process optimization. Standardization and alignment as per organizational strategy to optimize the quality of deliverables of clinical studies conducted with preferred CROs across regions. Contribution for insourcing model and development of process and SOPs and quality system across regions with operational excellence. Closely working with Safety Task Force Team for preparation of safety measures and process and its implementation for study execution and conduct during the pandemic. To ensure timely submission of clinical study dossier and study update reports to regulatory affairs for further submission to Health Authority in compliance with all applicable national regulatory guidelines. Active involvement in the preparation of Subject Expert Committee meetings for clinical study and participation in meetings and related discussions with medical and regulatory affairs, and the Research teams. Preparation of response to Health Authority queries during approval phase of the clinical study proposal. Provides expert opinion to Medical and Research and Regulatory Affairs on critical decisions and innovation and development plans for clinical studies of global and local products across therapeutic areas. Accountable for ensuring all legislation and guidelines and Company Policies and other applicable regulations. Accountable for the conduct of the study in a timely manner and in compliance with the applicable regulations and policies from study conceptualization till publication. Hands on experience of conducting virtual Investigator meetings with Investigators and KOLs for training on protocol and study procedures and study results. Hands on experience in planning and conducting Safety Adjudication Committee with Investigators and KOLs. Hands on experience of conducting the study with Risk Based Monitoring Approach. CRO and Vendor identification and budget negotiations. Involved in CRO and Vendor QA qualification process and Vendor Third Party Due Diligence completion. Involved in CRO and Vendor oversight and clinical supply management activities.



Review and approval of site feasibility and evaluation and monitoring and closeout visits reports. Ensure standardized contracting practices are implemented and maintained across all relevant vendors. Manage and be accountable for committed study budgets to meet the expectations within the organization regarding costs and budgeting and invoicing and turnaround times and contractual documentation and payment schedules by ensuring these are managed well. To ensure satisfactory CRO and Site audits and regulatory inspections with no critical or major findings. Prepare study progress reports and updates and presentations for cross functional stakeholders. People Management. Mentoring inhouse clinical team and CRO project managers and study personnel.

Job Posting: 07/05/2024

Panchkula

JOB REQUIREMENTS

- Mandatory Qualifications

B Pharmacy

M Pharmacy

Pharmacovigilance

- Work Experience in Relevant Field

10-25 Years

Technical Skills Required

Clinical Research. Clinical Trials. Clinical Monitoring.

JOB DESCRIPTION

- Who You'll Work With

Clinical Research department.

- What You'll Do

End to end project management of all phases of clinical studies for products under development stage and departmental activities in compliance with organization policies. Active involvement within cross functional stakeholders on shared goals. Study planning and management and execution and oversight and risk assessment and mitigation against project deliverables to ensure compliance. CRO Process optimization. Standardization and alignment as per organizational strategy to optimize the quality of deliverables of clinical studies conducted with preferred CROs across regions. Contribution for insourcing model and development of process and SOPs and quality system across regions with operational excellence. Closely working with Safety Task Force Team for preparation of safety measures and process and its implementation for study execution and conduct during the pandemic.



To ensure timely submission of clinical study dossier and study update reports to regulatory affairs for further submission to Health Authority in compliance with all applicable national regulatory guidelines. Active involvement in the preparation of Subject Expert Committee meetings for clinical study and participation in meetings and related discussions with medical and regulatory affairs, and the Research teams. Preparation of response to Health Authority queries during approval phase of the clinical study proposal. Provides expert opinion to Medical and Research and Regulatory Affairs on critical decisions and innovation and development plans for clinical studies of global and local products across therapeutic areas. Accountable for ensuring all legislation and guidelines and Company Policies and other applicable regulations. Accountable for the conduct of the study in a timely manner and in compliance with the applicable regulations and policies from study conceptualization till publication. Hands on experience of conducting virtual Investigator meetings with Investigators and KOLs for training on protocol and study procedures and study results. Hands on experience in planning and conducting Safety Adjudication Committee with Investigators and KOLs. Hands on experience of conducting the study with Risk Based Monitoring Approach. CRO and Vendor identification and budget negotiations. Involved in CRO and Vendor QA qualification process and Vendor Third Party Due Diligence completion. Involved in CRO and Vendor oversight and clinical supply management activities. Review and approval of site feasibility and evaluation and monitoring and closeout visits reports. Ensure standardized contracting practices are implemented and maintained across all relevant vendors. Manage and be accountable for committed study budgets to meet the expectations within the organization regarding costs and budgeting and invoicing and turnaround times and contractual documentation and payment schedules by ensuring these are managed well. To ensure satisfactory CRO and Site audits and regulatory inspections with no critical or major findings. Prepare study progress reports and updates and presentations for cross functional stakeholders. People Management. Mentoring inhouse clinical team and CRO project managers and study personnel.

- Soft Skills Required

Clinical Research. Clinical Trials. Clinical Monitoring.

- Functional Area

Clinical Research

- Recruitment Status

Active

- Employment Type

Full Time

- Date of Joining

Immediate

📌 Head Clinical Research Department (India)
🏢 Venus Remedies
📍 India