Associate Manager, Clinical Trials Regulatory Management

Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and programs RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs and may act as a Regulatory Oversight for a key customer Ability to...

The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client’s project team in the execution of clinical trials. Joining the team provides the opportunity to work with one single client and to manage clinical research projects in different therapeutic areas. We currently offer the exciting...

Proclinical is seeking a dedicated Senior Director for Clinical Trial Supply Management (CTSM) with a focus on Cell & Gene Therapies. The successful candidate will lead initiatives for all global CTSM activities in the Cell & Gene portfolio, supporting the development of future commercial launches. This role is crucial in delivering performance in the right...

Proclinical is seeking a dedicated Senior Director for Clinical Trial Supply Management (CTSM) with a focus on Cell & Gene Therapies. The successful candidate will lead initiatives for all global CTSM activities in the Cell & Gene portfolio, supporting the development of future commercial launches. This role is crucial in delivering performance in the right...

**Tasks & Responsibilities**: - In your new role, you are responsible for the design and preparation of late clinical development plans in the TA CardioMetabolism & Respiratory (CMR), and submission documents to prepare assets in one or more of the following areas: Obesity, Non-Alcoholic Steatohepatitis (NASH), Cardiovascular indications, and/or chronic...

Title: Global Clinical Operations Manager Location: Remote anywhere in Germany (with travel)✉️ Contact: frankie@elemed.eu The companyHere is a rare and great opportunity to join an international manufacturer in surgical devices and be part of this company’s new digitalized Clinical & Medical Affairs processes. You will be reporting directly to...

**Salary**: Highly Competitive Job type: PermanentDiscipline: Data Management**Location**: Germany- Frankfurt, Germany - Posting date: 27 Feb 2024 Reference: 59161 Proclinical are partnering with a pharmaceutical organisation who are recruiting for an individual to join their team. This role is on a permanent basis with the ability to work remotely from...

**The Position**: Join us as Senior Clinical Research Scientist and maximize the value of our fully outsourced trials in the Boehringer Ingelheim pipeline. You will be working in an open-minded team which allows you to create and contribute to structures and establish new processes. In this role you will act as the Clinical Trial Leader with full...

Proclinical are recruiting an Associate Director Clinical Data Management - Germany for a biotech organisation. This role is on a permanent basis with the ability to work remotely from anywhere in Germany. *** **Responsibilities**: - Serve as a mentor for the new starters or possibly assign to suitable team members this action. - Offer constant feedback...

**THE POSITION**: As (Senior) Clinical Program Leader you assume global responsibility and medical leadership for clinical development and evidence generation for assets in the indication area Gastroenterology/Crohn’s Disease from start of development through to registration. This may include definition of Target Product Profiles, design and execution of...

**Salary**: Highly Competitive Job type: PermanentDiscipline: CRA Manager**Location**: Germany- Frankfurt, Germany - Posting date: 14 Mar 2024 Reference: 59449 **Responsibilities**: - Oversee and manage the departments of Clinical Operations, Clinical Strategy & Development, and Clinical Systems. - Direct leadership and development of the department...

Job Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. At least 3 years' experience with submissions and...

Job Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. At least 3 years' experience with submissions and...

We are looking for an experienced CRA or Senior CRA (m/w/d) for a sponsor dedicated role in cooperation with Boehringer Ingelheim , one of the largest and most established pharmaceutical companies in Germany (family owned since 1885), with focus on therapeutic areas such as Pulmonology, Oncology and Neurology.When you join the IQVIA sponsor-dedicated cFSP...

Job Overview Manages a single department or work unit responsible for site activation. Sets goals and objectives for team members for achievement of short-term operational or tactical results. Must have former people management experience. Essential Functions Manages staff's delivery of site activation activities in accordance with...

Quality HeadWe're looking for a skilled professional to lead quality efforts as the Head of Quality. In this role, you'll guide the creation, implementation, and ongoing improvement of our Quality Management System and Quality teams.You'll be responsible for ensuring operations adhere to regulations and for preparing for regulatory inspections. Your work...

Company Description Ergomed PLC is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease. Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia Our company allows for employee visibility (you...

Proclinical is seeking a dedicated and experienced professional for the role of Head of Corporate Clinical Research & Development. This role involves overseeing the departments of Clinical Operations, Clinical Strategy & Development, and Clinical Systems. The successful candidate will be responsible for the medical-scientific strategy of developing new...

We are looking for an experienced CRA or Senior CRA (m/w/d) for a sponsor dedicated role in cooperation with Boehringer Ingelheim , one of the largest and most established pharmaceutical companies in Germany (family owned since 1885), with focus on therapeutic areas such as Pulmonology, Oncology and Neurology. When you join the IQVIA sponsor-dedicated...

**Salary**: Highly Competitive Job type: PermanentDiscipline: Programming**Location**: Germany- Frankfurt, Deutschland - Posting date: 08 Feb 2024 Reference: 58841 Proclinical are partnering with a biotech organisation who are recruiting for an individual to join their team. This role is on a permanent basis with the ability to work remotely from anywhere...