Senior Clinical Trials Manager
hace 3 semanas
Estimated Salary: $80,000 - $120,000 per annum
About Tfs HealthscienceTfs Healthscience is a leading global Contract Research Organization (CRO) with over 27 years of experience in clinical development. Our company values collaboration, innovation, and making a difference in the lives of patients.
Job DescriptionAs a Clinical Research Associate, you will be dedicated to monitoring on-site and remotely clinical trials in accordance with TFS and/or client company Standard Operating Procedures, FDA regulations, and GCP and ICH guidelines. Your responsibilities will include reviewing CRFs (paper or electronic) and subject source documentation for validity and accuracy, generating queries to investigational sites/clients to resolve problem data, and identifying site problems/deficiencies.
You will also contribute to the completion of the application to Ethics Committee/IRB, prepare necessary documentation enclosed to the application according to local requirements in cooperation with CTA and directed by Lead CRA/Project Manager. Additionally, you will participate in contract handling and negotiation, set up ISF and SMF, distribute to the investigational sites, and order, ship, and reconcile clinical investigative supplies for study sites.
Key Responsibilities:- Monitor on-site and remotely clinical trials in accordance with TFS and/or client company Standard Operating Procedures, FDA regulations, and GCP and ICH guidelines
- Review CRFs (paper or electronic) and subject source documentation for validity and accuracy and generate queries to investigational sites/clients to resolve problem data
- Identify site problems/deficiencies and bring to the attention of management through trip reporting, memos, and verbal communication with Project Manager or Lead CRA
To succeed in this role, you will need a Bachelor's Degree, preferably in life science or nursing; or equivalent. You should have minimum 1-2 years of relevant clinical experience and be able to work in a fast-paced environment with changing priorities. You will also need to understand basic medical terminology and science associated with the assigned drugs and therapeutic areas.
What We OfferWe provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You'll be joining a team that values collaboration, innovation, and making a difference in the lives of patients.
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