phase as an integral member of the study management team. Determine regulatory strategy/expectations and parameters... for submissions and all necessary authorizations. Identify regulatory complexity and challenges and offer creative and practical...
IQVIA, you will have the opportunity to advance study start-up and regulatory activities by understanding client objectives. You will be in... ability in the leadership of a team of individuals in study start-up Knowledge of applicable international regulatory...
Rhoboth internal and external study specific kick off meetings Review and approve regulatory green light forms ensuring... according to regulatory requirements. Coordinate the production of the Clinical Study Report ensuring that that submission is made...
Owlstone Medicalfor trials, IRB/IEC submissions and documentation for regulatory dossiers. Solely responsible for ensuring collection of the... required essential documents for study start-up and throughout the conduct of a trial. You will conduct on-site training and motivate the...
The Recruitment Co.preparing study documentation for trials, IRB/IEC submissions and documentation for regulatory dossiers. You will be solely... responsible for ensuring collection of the required essential documents for study start-up and throughout the conduct of a trial...
Cydenthat clinical trials adhere to strict regulatory guidelines, which are in place to protect the rights and welfare of study... of regulatory submissions and compliance. Maintain a deep understanding of new and existing regulations that may impact clinical...
The George Institute for Global Healthto IND, NDA, PMA submissions via overseeing medical documentation and active participation in meetings with regulatory... agencies Clinical lead for early development study conduct including study design, protocol writing, regulatory documents...
Bicycle Therapeutics, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical... subject recruitment plan in line with project needs to enhance predictability Administer protocol and related study training...
IQVIA. Clinicology offers a full range of services including site start-up, monitoring, project management, regulatory submissions... close out. Manage the technical, financial and operational aspects of projects. Drive assigned projects through study start up...
Clinicologyrelated documents, country/site selection, start up, study conduct and oversight, data review, and close-out... with clinical protocol development and/or regulatory submissions and management. Experience writing scientific documents...
Adaptimmuneare used to support drug applications and regulatory submissions to health authorities globally. Trial Data Management (TDM... experience for our patients. Improve efficiency of study start up by reducing the time from study initiation to first site...
MSDrelated documents, country/site selection, start up, study conduct and oversight, data review, and close-out... with clinical protocol development and/or regulatory submissions and management. Experience writing scientific documents...
Adaptimmuneas appropriate Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment... with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference...
IQVIA, engaging in operational and regulatory reporting, resolving customer inquiries, and contributing to operational change... review all in-scope submissions and processes these in line with agreed service levels. Execute tasks related to the...
The Travelersagencies (FDA, EMA) to support clinical trial regulatory submissions Liaise with other functions to enable quality clinical... and selection, and provide assistance with study start-up activities Participate in Investigator meeting planning and execution...
Philipsorganisations to support partners at the preclinical, clinical, and post market stage to develop, manufacture, obtain regulatory... development from the start, with the insight they will have in market needs (e.g., product demand, target selection, sample...
Novacytmaintaining standard operating procedures, supporting training as qualified, engaging in operational and regulatory reporting... Lifecycle Support: Thoroughly review all in-scope submissions and processes these in line with agreed service levels. Execute...
The Travelers