EMPREGO CLINICAL TRIAL MANAGER CTM

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...

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

Gcp and clinical trial experience... iqvia is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences...

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

Thorough understanding of regulated clinical trial environment and in-depth knowledge of drug development process good regulatory and/or technical writing skills...

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

Under the direction and supervision of line manager and/or other designated clinical team members you will have the possibility to gain a complete overview of clinical...

Good understanding of clinical trial processes... be responsible for providing support to clinical projects under direction and supervision of line manager and/or...

Detailed understanding of clinical trial start-up processes...  supports country-level intelligence on start-up (su) and clinical trial regulatory (ctr)...

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

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

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