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Senior Clinical Trial Manager
hace 1 mes
As a Senior Clinical Trial Manager, you will be responsible for coordinating and leading local trial teams to deliver high-quality data and trial documents/records that are compliant with assigned protocols, codes of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and regulatory requirements.
Key Responsibilities:- Conduct country do-ability and site feasibility assessments in conjunction with CTA, CRA, and PM.
- Implement local criteria for site selection and ensure consistent conduct of pre-trial assessment visits.
- Collaborate with the CPL, PM, local management/Country Head, and Protocol Owner to select final site lists.
- Contribute to the development of trial plans, safety monitoring plans, filing and archiving plans, and investigational product documents at a country level.
- Lead and coordinate local trial team activities in compliance with GCO Standard Operating Procedures (SOP), Work Instructions (WI), and applicable regulations.
- Ensure that all SAEs/PQCs are reported within reporting timelines and documented as appropriate.
- Maintain and update trial management systems, including CTMS, eTMF/LAF, Trial Master Source, and Sharepoints.
- Monitor country progress and initiate corrective and preventive actions when the trial deviates from plans.
- Communicate study progress and issues to study management teams.
- A minimum of a BA/BS degree in a health or science-related field.
- Experience as LTM/CTM of at least 4/5 years.
- Experience in submissions.
- Specific therapeutic area experience may be required depending on the position.
- Solid communication and computer skills.
- Proficient in speaking and writing the country language and English language.
