EMPREGO SR CLINICAL TRIAL MANAGER

Supports inspection readiness for clinical trial management scope...    reviews the project oversight dashboards and other clinical trial systems (e...

Knowledge of clinical trials - knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i...

Experience in clinical trial planning and conduct... previous cross-functional clinical trial management experience in a cro, biotech or pharmaceutical company at...

Prepares and/or reviews regulatory documents to support clinical trial submissions... prepares and maintains core clinical trial submission dossiers in accordance...

Prepares and/or reviews regulatory documents to support clinical trial submissions... independently provides regulatory support for complex projects and programs...

Purpose prepares and/or reviews regulatory documents to support clinical trial submissions... independently provides regulatory support for complex projects and...

With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our ppd clinical research portfolio, our...

Reconciles contents of the isf with the trial master file (tmf)...  participates in global clinical monitoring/project staff meetings (inclusive of sponsor representation...

Experience in operational safety within clinical studies... ensure early medical review of clinical trial serious adverse events to identify unanticipated adverse...

Years’ clinical trial experience 3 years’ experience at a cro or clinical trial services provider 3 years’ project management/functional lead experience #li-remote...

Job responsibilities qualifications what we’re looking for proficiency in working with clinical trial data (including sap/csr/tlf workflow including biomarker studies)...

Team player with a strong clinical aptitude... clinical research, pricing and/or marketing) to develop optimal solutions... implement therapy development strategy...

• advise, consult and make final recommendations to all aspects of clinical regulatory intelligence...   our clinical development model brings the customer and the...

Conduct regular annual country review of regulatory source documents for the clinical regulatory intelligence... conducts searches within commercial regulatory intelligence...

Discover impactful work: the sr... provide support and guidance to early-stage program teams with various rwe activities to optimize clinical development...

May escalate serious issues to manager... successfully completes complex engineering work in one or more of the following: technology development, product design...

Demonstrate proficiency with meddra and whodrug coding integrate scientific expertise with knowledge of safety database functions to ensure accurate and comprehensive...

•    good understanding of clinical trial process across phases ii-iv and ich gcp... job responsibilities  •    provide support with site selection lead and project...

· 3 years of prior relevant experience including experience managing clinical trial safety/post-marketing safety; or equivalent combination of education, training...