The individual in this position will participate on multi-disciplinary project teams to plan and execute successful clinical studies in support of corporate objectives. The Clinical Trial Manager will demonstrate proficiency in all areas of clinical study development and execution, with an ability to build and direct effective multi-disciplinary project teams.
Accountabilities & Responsibilities
- Oversee the planning and execution of clinical studies to ensure that deliverables are completed on time and within budget
- Develop and manage study related documents and materials such as investigational plans, case report forms, study manuals, monitoring plan, informed consents, recruitment materials, and other study related tools
- Interact with investigative sites through training and ongoing communication to ensure successful execution of the clinical trial
- Independently conduct clinical trial monitoring including qualification, initiation, monitoring, and close-out visits, as needed
- Oversee the appropriate reporting and documentation of adverse events and protocol deviations per investigational plan requirements
- Plan investigator and coordinator meetings and prepare and present meeting materials
- Ensure that internal and external clinical study teams fulfill their responsibilities in accordance with corporate standards, regulations, and Good Clinical Practices
- Manage external vendors/CROs to ensure that deliverables are completed on-time, within budget, and are consistent with the scope of work
- Participate on cross-functional core project team to ensure clinical deliverables are aligned with corporate objectives
- Develop an understanding of competitive landscapes for assigned products and therapeutic areas
- Demonstrate understanding of Medical general business functions, products, and procedures
- Assist with data analysis and interpretation of the results
- Coordinate the development and submission of clinical reports and abstracts/manuscripts
- Oversee development and management of the clinical database
- Provide work direction to study team for larger trials with future opportunity to manage Clinical personnel
Requirements
• Min Degree, preferably in Science / Life Sciences / Public Health / Health Sciences / Pharmacy / Medicine / Nursing or similar from an accredited university
• Knowledge of GCP guidelines and applicable regulations and guidelines of clinical research, or ethical principles relating to human biomedical research
• Able to work independently, as well as part of a team
• Able to work with a high degree of accuracy and attention to detail
• Possess excellent analytical, organisation, communication, and interpersonal skills
If you are interested in the position, do kindly drop your most updated resume to
[email protected] (Attn: Clinical Trails)
Thank You.
Leon Leong De Cong
R1551708
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599
