Senior Clinical Trial Manager
Abata TherapeuticsSalary not specified
Full Time
Senior (5 to 8 years)
[Remote] (Associate) Medical Director, Pediatrics - EMEA at Thermo Fisher Scientific
Portugal
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Clinical Research, Pharmaceuticals, HealthcareIndustries
Requirements
- Medical Doctor with a specialty in Pediatrics and demonstrated clinical experience running Pediatrics patients in hospital practice
- Significant experience within pharmaceutical industry, clinical trials, and pharmaceutical medicine
- Solid experience with PIPs (pediatric investigation plan)
- Fluent in spoken and written English
- Demonstrated understanding and experience with NDA submission process
- Demonstrated understanding of regulatory guidelines for adverse event reporting
- Strong communication & presentation skills and is a strong teammate
Responsibilities
- Provide medical leadership to study teams, including creating clinical trial protocols using latest scientific information
- Contribute to site selection, review and approve study protocols and amendments, Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), protocol deviation decisions, and other clinical documents
- Perform real-time medical monitoring of clinical studies to ensure medical validity of primary endpoints, study subject safety, and early identification of medical issues; pro-actively address customer concerns in consultation with Global Medical Indication Lead
- During initial protocol review, consult with internal groups on procedural and budgetary items and protocol amendments; acquire dedication from other functions to address issues timely
- Serve as chief liaison between sponsor and PPD internal departments during all study phases
- Educate investigator sites by delivering protocol-specific lab procedures presentations and demonstrations at investigator meetings
- Control, handle, and follow day-to-day activities during clinical trials to resolve issues and answer queries
- Act as medical point of contact for internal and external stakeholders: interact with investigators, answer IRB and Health Authority questions, prepare and present to study executive and safety committees, provide medical training at investigator meetings, and train CRAs in new indications
- Ensure study compliance for all medical aspects by applying relevant SOPs and GCP
- Closely collaborate with cross-functional study team members to ensure medical risks, issues, and results are clear to all parties
Skills
Pharmacovigilance
Clinical Trials
Medical Monitoring
Protocol Development
Clinical Study Reports
Informed Consent Forms
Case Report Forms
Site Selection
Pediatrics
Thermo Fisher Scientific
Provides life sciences products and services
About Thermo Fisher Scientific
Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.
Waltham, MassachusettsHeadquarters
1956Year Founded
$17MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees