Trial Oversight Specialist
hace 4 días
Fortrea is a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas.
Our Mission:
We transform drug and device development for partners and patients across the globe.
Your Role:
As a Clinical Team Lead, you will be responsible for overseeing clinical trial activities, ensuring compliance with regulatory requirements and company procedures. Key responsibilities include site selection, trial conduct, and closeout.
Responsibilities Include:
- Selecting sites and conducting trials according to the clinical trial protocol.
- Supervising local adaptation of required documents for submission.
- Ensuring all Regulatory Requirements are satisfied prior to trial/site initiation.
- Updating dashboards for trial oversight.
- Overseeing recruitment and defining strategic approach at local level.
- Managing and reviewing OPU trial budget.
- Ensuring appropriate trial-specific training of team members.
- Conducting trial oversight, monitoring compliance of trial sites and BI team to GCP, local regulations, BI SOPs, and adherence to trial protocol.
- Serving as trial contact for CRAs, investigators, and site staff.
- Collecting required documents and ensuring timely archiving of relevant documents for the eTMF and CTR Appendices.
Requirements:
- At least 5 years of experience in Clinical Research working for a pharmaceutical company or CRO.
- Strong clinical trial project management experience or CRA lead with potential to develop.
- Regional LATAM experience is preferred.
- Previous CRA experience is desirable.
- Understanding of local/regional major regulations.
- University degree in Life Science.
- Experience in managing oncology trials is desirable.
- Fluent in English is a must.
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