Senior Medical Project Lead - Clinical Trial Oversight

ThermoFisher Scientific; España; Hybrid; PHP 4,378,000 - 6,879,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Medical Monitoring Lead for global clinical safety projects. You will manage safety data reviews, lead risk assessment, and coordinate with multi-disciplinary teams to ensure compliance with GCP and regulatory requirements.

The role requires a Bachelor's degree in Nursing or related Health Sciences, 5+ years in clinical safety, and strong project and budget management skills. You will act as primary contact for study teams and support business development.

Qualifications

• Advanced knowledge of GCPs for medical oversight of clinical trials.
• Knowledge of drug development and safety reporting
• Advanced knowledge of safety data trending to include coding
• Working knowledge of biostatistics, data management and clinical procedures
• Excellent problem solving and critical thinking skills
• Excellent project management and budget skills
• Effective mentoring skills and ability to train and lead others
• Strong oral and written communication skills
• Strong attention to detail
• Ability to work in a collaborative team environment
• Ability to maintain a positive and professional demeanor in challenging circumstances

Responsibilities

• Works independently to perform first pass review of safety data, utilizing line listings, company dashboard(s) and/or other visualization tools.
• Reviews data and provides summations for safety review meetings.
• Reviews designated sections of aggregate reports.
• Independently functions as the Project Lead for medical monitoring services when SAE case processing has not been contracted.
• Creates and maintains medical management plan(s) on studies and ensures that the processes included in the plan document are reflective of the contract and services requested.
• Works independently to monitor the project financial status, unit forecasting, actual realization, and team allocations in systems.
• Independently determines hours required for out of scope work for the teams and provides this to the finance/study team for contract modifications.
• Resolves complex problems through in-depth evaluation and offers solutions.
• Presents at business development, client, and investigator meetings and participates in strategy/business development calls.

Skills

GCP knowledge

Safety data trending

Project management

Budget skills

Mentoring

Communication skills

Attention to detail

Team collaboration

Education

Bachelor's degree in Nursing or related Health Sciences

Job description

Thermo Fisher Scientific is seeking a Medical Monitoring Lead for global clinical safety projects. You will manage safety data reviews, lead risk assessment, and coordinate with multi-disciplinary teams to ensure compliance with GCP and regulatory requirements.

The role requires a Bachelor's degree in Nursing or related Health Sciences, 5+ years in clinical safety, and strong project and budget management skills. You will act as primary contact for study teams and support business development.