Should have experience in Phase I, II, III drug trials
Earlier experience in line management activities
Good communication skills both oral and written are a must
Applies strong analytical and business communication skills
Familiarity with medical terminology and/or GCP guidelines strongly preferred
Applies technical standards, principles, theories, concepts, and techniques
Excellent organizational skills are required
Demonstrated success in problem solving
Good computer skills are required. Working knowledge of MS Word, Excel, and PowerPoint is required, and applications as needed for job
Detail oriented
Ability to work in a team environment
Self-motivation, eagerness to grow professionally and commitment to self-development
Occasional travel may be required.
Education: Any life science degree. Preferably pharmacy (B. Pharmacy/M. Pharmacy/ PharmD)
Job Responsibilities:
Project Management
Manage studies independently under directions of Clinical Director
Prepare study execution strategies, challenges, and mitigations
Forecast study expenses and support Management
Prepare project management plans, Gantt charts, study plans
Preparing and conducting pre- study activities, site selection, initiation visits, routine monitoring and close- out visits and performing feasibilities.
Preparing applications to ethics committees and supporting the regulatory department with the application to the regulatory authorities.
Planning and participating at Investigator meeting(s) responsible for the site(s) and on- site management during the study process.
Ordering and coordinating study supplies.
Preparing study documentation and assisting the Clinical Quality Assurance Manager/ regulatory authorities during audits/ inspections in- house or on site.
Negotiating contracts with the clinics, local/ central laboratory (ies)/ pharmacy etc.
Responsibility for the final archiving of all study documentation in- house Monitoring and Oversight communicating with study teams and sponsors.
Regulatory Documentation Management Administration Providing Status Reports to line manager.
Planning budget activities for the trials Managing timelines and deliverables for the trials.
