A leading biotech company is on the lookout for a Senior Clinical Research Associate to support their clinical operations team. This innovative company is at the forefront of developing therapies that address critical unmet medical needs, with a strong focus on rare diseases. By joining this team, you will be instrumental in advancing pioneering treatments that have the potential to revolutionize patient care.
The leadership team comprises seasoned industry experts with a wealth of experience in drug development and commercialization. They have a proven track record of successfully guiding multiple programs from early development stages through to regulatory approval and market launch. With a robust pipeline of promising candidates, the company is strategically positioned for sustained growth and success in the biotech industry.
Responsibilities:
- Manage clinical trial activities to ensure studies are completed on time, within budget, and in compliance with regulatory standards.
- Oversee trial aspects, including study start-up, patient enrollment, site interactions, and data management.
- Draft and review key study documents, such as informed consent forms and case report forms.
- Select and manage study sites, evaluate CROs and other service providers, and oversee contracts and budgets.
- Provide study updates to cross-functional teams and address issues with sites and CROs.
- Conduct site visits, including qualification, initiation, monitoring, and close-out visits.
- Support internal and external audits, addressing and resolving any findings.
Qualifications and Experience:
- Bachelor's degree in a scientific or health-related field.
- At least 3 years of experience in clinical research, ideally within a biopharmaceutical or CRO setting.
- Experience with rare disease trials is highly preferred; early-phase development experience is beneficial.
- Knowledge of FDA regulations and ICH/GCP guidelines.
- Strong organizational and multitasking skills, with the ability to work in a collaborative team environment.
- Excellent written and verbal communication skills.
- Proficiency in Microsoft Office and experience with clinical trial management systems (e.g., Medidata Rave, InForm).
If you are interested, plase dont hestitate to apply.
