Clinical Study Manager (CSM)
Are you an experienced and talented Clinical Study Manager with a strong educational background in Life Sciences, keen to work for a leading CRO?
If you want to build a stronger, more sustainable future and cultivate your career as a Clinical Study Manager read below and apply here.
For this role you are offered a competitive remuneration package and a dynamic working environment.
What is expected of you:
You will manage assigned clinical trial(s)/programs including timelines, budgets, resources, and key project deliverables in compliance with SOPs, Regulatory requirements and ICH/GCP guidelines.
Key Accountabilities
- Overall coordination and management of clinical trials from startup to closeout
- Budget and Timelines Management
- Contract Negotiations
- Vendor Management. Develop outsourcing specifications on vendor requests for proposal and scope of work agreements
- Work closely with external and internal stakeholders in project initiation phase to define scope, schedule, cost and budget
- Ensure all project deliverables meet customers’ accurate forecasts
- Support the Clinical Study Team
- Identify and provide solutions to clinical development issues or risks
- Participate as appropriate in internal and external audits
- Mentor staff, coach CRAs and serve as a resource for new employees
- Demonstrate flexibility, positive thinking, problem solving attitude and an appetite for numerous projects of varied shape and size
- Promote a healthy working environment by leading projects’ teams by example
- Communicate effectively with all other study team members at local & global level
For this role you will be expected to have the following:
- Life Sciences or related degree
- 5 years of experience in interventional clinical trials and at least 2 years of experience as a Study Manager
- Thorough understanding of country level regulations, ICH and GCP guidelines
- Thorough understanding of cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, and regulatory affairs
- Fluency in written and oral English
- Computer literacy
- Ability to lead a cross-functional team in a matrix environment
- Strong interpersonal, negotiation, verbal and written communications and presentation skills
- Experience in project organizational structure development, team/resource management and stakeholder management
