Duties, Responsibilities and Tasks
Provide overall management of clinical research studies. General areas of responsibility include but are not limited to: Sponsor liaison, project initiation and on-going assessment, resource planning, project implementation, leading and motivating a cross-functional team, milestone planning and tracking, ensuring that projects are progressing according to contract and quality standards, SOPs, ICH-GCP and/or other guidelines to fulfill local regulations, production of key project progress reports, management of communication between AGU project team, Sponsor, contract and financial accountability.
• Assume overall responsibility for the preparation of protocols and Case Report Forms, finalization of monitoring plan, Ethics committee approval, development of recruitment strategies to increase patient randomization into the trial, the provision of clinical trial materials, and management of the trial.
• Ensure that all aspects of GCP are complied with at all times through provision of training at start-up and initiation meetings for clinical trials and on-going SOP development.
• Coordinate the smooth monitoring of the trial by following the work of the CRAs, establishing audit procedures and ensuring that cleaned data is entered into the database in a timely fashion.
• Pro-actively work with members of the project team, identifying issues that might delay the project and making recommendations to improve time lines for project completion.
• Compile and drive documentation for the project, ensuring the accuracy and quality of regulatory data.
• Plan and participate in clinical research team meetings (AGU, Sponsor, Investigators) ensuring that colleagues are updated on all relevant issues.
• Assist the Study Director and ensure the smooth running of the clinical research team by developing systems to track the project including all study, investigator and ethical review board information, patient recruitment activity and financial management.
• Share responsibility for the clinical trial program budget planning, resource allocation and preparation of quarterly reports.
• Coaching of CRAs in various aspects of management that are relevant to particular project issues.
• Ensure that study specific management tools and Central File Maintenance plan are set up
• Ensure the project is completed within budget, schedule and according to contract specifications.
• Initiate, facilitate and maintain regular contact and communication with the Study Sponsor.
• Conduct regular audits of activities related to the project
• Collaborate in the ongoing development and implementation of processes (SOPs)
• Collaborate in the ongoing development of training materials and curricula
• Organize and lead training sessions for the research project team
• Responsible for review, assessment, and reporting of all adverse events of the clinical trial.
• Responsible for the preparation of all reports and medical writing
The position offers competitive salary and benefits like housing and transportation allowances and health insurance.
Job Details
| Date Posted: | 2012-12-23 |
| Job Location: | Bahrain |
| Job Role: | Healthcare/Medical |
| Company Industry: | Education, Training, and Library |
Preferred Candidate
| Career Level: | Mid Career |
| Degree: | Master's degree |
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