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Clinical Research Project Manager
hace 1 semana
The Clinical Team Lead 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.
Key Responsibilities:
- Selecting sites and conducting trials according to the clinical trial protocol.
- Supervising local adaptation of required documents for submission.
- E nsuring 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.
