Clinical Trial Submission Management Specialist

Job DescriptionRoles & Responsibilities:- Be assigned to one or more Amgen products under development to ensure Clinical Trial Application approvals in the EU throughout the whole study lifecycle. As technical experts in the EMA Clinical Trial Information System (CTIS), ensure compliance with the EU Clinical Trials Regulation (EU CTR) for every Clinical...

Job DescriptionThe Senior Associate, Clinical Trial Submission Management, will help ensure the technical compliance of our Clinical Trial submissions via the smooth compliant flow of information between all functional areas, internal and external to GRAAS, local offices, external partners and regulatory authorities. This vital role is assigned to one or...

Job Title: Regulatory Submission SpecialistWe are seeking a highly skilled Regulatory Submission Specialist to join our team. The ideal candidate will have extensive knowledge of EU Clinical Trial Applications and experience in regulatory document management.Key Responsibilities:Ensure technical compliance of clinical trial submissions via smooth information...

Job Title:Clinical Trials CoordinatorWe are seeking a skilled professional to support the management of clinical trials. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements and coordinating submissions in various systems.Main Responsibilities:Assignments: Be assigned to one or more projects under...

Job Description:The position involves leading and supporting various clinical trial and marketing application submissions. You will be responsible for managing the creation, maintenance, and overall management of global/submission content plans, reports, and dashboards.You will serve as a point of contact between functional contributors and external partners...

Job DescriptionJob Title: Clinical Trial ManagerOnsite - HyderabadCompany Overview: We eteraflex connects a fast-growing global CRO specializing in oncology, rare diseases, and immunotherapies. Our mission is to accelerate access to innovative treatments by combining regulatory precision with deep site engagement, particularly in complex government-led...

Job Title: Clinical Trial ManagerOnsite - HyderabadCompany Overview: We eteraflex connects a fast-growing global CRO specializing in oncology, rare diseases, and immunotherapies. Our mission is to accelerate access to innovative treatments by combining regulatory precision with deep site engagement, particularly in complex government-led research...

Job Title: Clinical Trials Vendor ManagerAbout the Role:We are seeking a highly skilled Clinical Trials Vendor Manager to join our team. The ideal candidate will have experience in managing vendors for clinical trials and pharmacovigilance processes.The successful candidate will be responsible for ensuring that vendors meet all worldwide regulatory authority...

Job DescriptionThe Clinical Trial Operations Lead is a key member of the clinical trial management team. The successful candidate will be responsible for ensuring the timely and effective execution of clinical trials from planning to completion.Key responsibilities include:Leading the development and implementation of clinical trial strategies and...

Job Description">As a key player in our team, you will leverage your expertise to provide exceptional support to external suppliers, ensuring their effectiveness in delivering clinical trials for our study teams. This vital role involves working closely with internal and external stakeholders to resolve technical issues quickly, perform root cause analysis,...