Clinical Trials Management Stellenangebote in Berlin

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Stellenangebote Clinical Trials Management Berlin Jobs bei StepStone

Job vor 2 Tagen gefunden Immutep GmbH

Clinical Trials Associate (CTA) Support (m/w/d) - Admin Operations Assistance

• Berlin Homeoffice möglich

MEHR

[...] the ASX and NASDAQ. Location: Berlin, Germany; full- time, hybrid role (office/ remote) Summary: As a result of our continuous progress in our projects, we are looking to expand our team and are therefore seeking a highly motivated and experienced Clinical Trial Associate to join our dynamic team. You will play a crucial role in supporting the Clinical Trial Manager (CTM) and other team member, as needed, in the day- to- day clinical operations activities involved in the planning, execution, and management of assigned clinical trial (s) . Ideal candidates will have a solid background in trial and study site management, vendor [...] CTA or experience in a similar role ( g. , clinical site, CRO, Sponsor or clinical trial vendor) preferably on the Sponsor/ pharma side. Knowledge and experience in relevant legislation and international guidelines (ICH- GCP) for the performance of clinical trials. Advanced understanding demonstration of proficiency in CTA tasks. Experience setting up maintaining eTMF. Very good knowledge of standard software (Word, [...]

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Job vom 03.12.2024 Immutep GmbH Clinical Trial Supply Manager (m/f/d) • Berlin Teilzeit Homeoffice möglich

MEHR

[...] publicly traded on the ASX and NASDAQ. Location: Berlin, Germany; office based, 75- 100 negotiable, or remote with 10 presence in the Berlin office Summary: Our lead candidate, the LAG- 3 based recombinant protein eftilagimod alfa, is currently undergoing pivotal clinical trials in cancer on a global scale. You will work closely with the Senior Director of Manufacturing to define and execute [...] shipments of IMPs from central depot to regional hubs and local depots. Develops, maintains and executes an optimal resupply strategy with proactive planning, appropriate lead- time and replenishment quantities to ensure compliance and continuity of clinical supplies, including proactive expiry management of clinical supplies. Manages and provides support in establishing of IWRS or IRT system of blinded and open label trials. [...]

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Stellenangebote Clinical Trials Management Berlin Jobs bei Neuvoo.com

Job gestern gefunden Immutep GmbH

Clinical Trials Associate (CTA) Support (m/w/d) - Admin Operations Assistance (21. 12. 2024)

• Berlin

MEHR

[...] the ASX and NASDAQ. Location: Berlin, Germany; full- time, hybrid role (office/ remote) Summary: As a result of our continuous progress in our projects, we are looking to expand our team and are therefore seeking a highly motivated and experienced Clinical Trial Associate to join our dynamic team. You will play a crucial role in supporting the Clinical Trial Manager (CTM) and other team member, as needed, in the day- to- day clinical operations activities involved in the planning, execution, and management of assigned clinical trial (s) . Ideal candidates will have a solid background in trial and study site management, vendor [...] a CTA or experience in a similar role (g. , clinical site, CRO, Sponsor or clinical trial vendor) preferably on the Sponsor/ pharma side.- Knowledge and experience in relevant legislation and international guidelines (ICH- GCP) for the performance of clinical trials.- Advanced understanding demonstration of proficiency in CTA tasks. Experience setting up maintaining eTMF.- Very good knowledge of standard software (Word, [...]

Job gestern gefunden CSL Seqirus (Noch 15 Std. zum Bewerben) Medical Director for Germanywith expertise in Vaccines • Berlin Führungs-/ Leitungspositionen

MEHR

[...] our vision is that through the power of innovation, we will advance science to enhance public health worldwide. As Medical Director for Germany, you will lead a team of highly talented team medical affairs colleagues that have both scientific and clinical expertise in Germany and Southern Europe (Italy and Spain) . You will lead the team to successfully execute all critical medical affairs functions, which include developing and executing the strategic medical plans for the region, managing key thought- leader relationships, publishing data from sponsored trials, disseminating/ presenting educational information on the portfolio, answering questions from healthcare clinicians and disease experts regarding product safety or efficacy [...] achieve successful medical objectives for Seqirus vaccines in Central and Southern Europe- Engage with external experts, research partners, public health, and government stakeholders to promulgate Seqirus scientific platform and enhance company reputation.- Provide medical governance into decision- making and issue management and external communications.- Ensure local pharmacovigilance compliance. In this exciting role will report to the Head of Medical, International Region [...]
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Stellenangebote Clinical Trials Management Berlin Jobs bei Jobleads

Job gestern gefunden

Associate Director Clinical Development

• Berlin Führungs-/ Leitungspositionen

MEHR

Associate Director Clinical Development (all genders) Mainz, Germany; Berlin, Germany; Cambridge, US; Gaithersburg, US; London, United Kingdom full time hybrid Job ID:6744 Responsibilities. [...] Development to support development of clinical strategies, plans and their operationalization especially on trial level. Drives the operational planning, content, execution and delivery for our programs and studies. Will manage day- to- day clinical activities for our clinical studies including management of protocol amendments, overseeing data review activities and communicating with investigator/ sites where appropriate. Assumes Program Lead responsibilities if assigned [...] benefit assessments supported by the Clinical Trial Scientists and Pharmacovigilance. Collaborates closely with Pharmacovigilance on development of Risk Management Plans. Collaborates and gives guidance for the Clinical Trial Scientists, and works with them on day- to- day basis on clinical trials, driving overall progress of study implementation. Supervises and gets involved in ongoing medical data review, ensures medical queries of running [...]

Job vor 7 Tagen gefunden Clinical Research Associate • Hamburg, Berlin

MEHR

TFS Health Science is a leading global mid- size Contract Research Organization (CRO) dedicated to partnering with biotechnology and pharmaceutical companies throughout their entire clinical development journey. With expertise in full- service capabilities, resourcing, and Functional Service (FSP) solutions, we re looking for a talented [...] Associate with TFS Health Science, you will be a vital part of our SRS/ FSP team, working exclusively with a world- renowned global pharmaceutical/ biotech sponsor. You will play a crucial role in ensuring the quality and integrity of clinical trials, driving them forward from start to finish. Key Responsibilities Submission Amendment Support: Assist with initial and ongoing submissions, including amendments to ethics committees. Regulatory Reporting: Manage periodic reporting to ethics committees, including the reporting of safety events. Pre- activation SIV Support: Contribute to site pre- activation activities and support Site Initiation Visits (SIVs) . Monitoring Site Management: Conduct both onsite monitoring and periodic central monitoring to ensure trial integrity; manage site relationships and processes. Documentation Closeout: Maintain [...]
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Job vor 13 Tagen gefunden

Head of Regulatory Affairs- Tether Evo (Fully Remote, Worldwide)

• Berlin Führungs-/ Leitungspositionen

MEHR

[...] around the globe. Tether is seeking an experienced and visionary Head of Regulatory Affairs to design and execute global regulatory strategies for our Tether Evo business vertical. If you have expertise in medical technology regulation, including pre- market approval processes, clinical trial oversight, and interaction with regulatory bodies both in the US and internationally, we want to hear from you. What [...] monitoring for change across regulations to ensure proactive compliance. Product Development: Provide premarket regulatory strategy guidance as part of the product and product development processes to comply with regulatory requirements for early feasibility, first- in- human, investigational use, and clinical trials across multiple jurisdictions. This includes advising on risk assessments, biocompatibility and safety evaluations for Class 2a/ 2b and Class 3 active implantable medical devices, as well as the compilation of submission dossiers and management of breakthrough, TAP, and other available regulatory acceleration programs. Regulatory Approval Process: Oversee regulatory approval processes, including US FDA pre- [...]
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Job vor 13 Tagen gefunden Team Lead Copywriting (f/m/d) • Hamburg, Berlin Führungs-/ Leitungspositionen

MEHR

[...] creation projects from concept to delivery, working closely with project stakeholders to ensure high- quality, on- time deliverables. Being responsible for error- free quality control of all medical copy deliverables. Overseeing development of medical copy concepts for marketing materials promoting clinical trials, such as patient brochures, leaflets, websites, banner ads etc. Serving as the primary point of contact for clients regarding all copy matters, managing expectations through effective communication. Continuously improving the management of medical copy concepts and deliverables, ensuring effective prioritization, planning and forecasting the team s capacity, along with timely delivery. [...]

Job vor 13 Tagen gefunden

Director of Commercial Operations

• Berlin Führungs-/ Leitungspositionen

MEHR

[...] individual with outstanding operational skills and a strong drive to collaborate with both commercial and technical stakeholders (e. g. , data science, ML engineering) to generate new business opportunities across a range of use cases (e. g. , drug discovery, clinical trials, RWE, clinical tooling) . Building on their life sciences data and R D expertise, the role will own all business [...] the Innovative Medicines Initiative (IMI) . Client Engagement: Build and maintain relationships with key executives and stakeholders (incl. R D executives, ML scientists, legal compliance stakeholders and procurement) in life sciences, engaging them throughout the sales process. Pilot Scoping and Management: Work with field engineering and other internal and external stakeholders to define the scope, objectives, and success criteria of pilot [...]
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Job vom 23.11.2024 Medical Science Liaison • Hamburg, Niedersachsen, Berlin

MEHR

Updated: November 20, 2024 Location: Hamburg, Lower Saxony, Germany Job ID: 6719- OTHLOC- CVJw YfwS The Regional Medical Science Liaison (MSL) serves as the primary field- based point of contact with healthcare providers (HCPs) including clinical investigators on a range of clinical and scientific issues. The primary role is to deliver and facilitate medical education and [...] products, activities, and the disease area, and ensure these insights are effectively brought back to internal teams, disseminated, and leveraged through collaboration with cross- functional partners. Facilitate clear communication between the business and investigators in investigator engagement for both client trials and investigator- sponsored studies and barriers to enrolment for pipeline assets. REQUIREMENTS Advanced Degree MD, PhD, PharmD. Demonstrable experience in [...]
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Job vom 23.11.2024

Medical Science Liaison

• Berlin

MEHR

Updated: November 20, 2024 Location: Berlin, BE, Germany Job ID: 6719- OTHLOC- CDHw Yfwy The Regional Medical Science Liaison (MSL) serves as the primary field- based point of contact with healthcare providers (HCPs) including clinical investigators on a range of clinical and scientific issues. The primary role is to deliver and facilitate medical education and [...] products, activities, and the disease area, and ensure these insights are effectively brought back to internal teams, disseminated, and leveraged through collaboration with cross- functional partners. Facilitate clear communication between the business and investigators in investigator engagement for both client trials and investigator- sponsored studies and barriers to enrolment for pipeline assets. REQUIREMENTS Advanced Degree MD, PhD, PharmD. Demonstrable experience in [...]

Job vom 07.11.2024 Product Owner (f/m/d) - ahead Corporate Partner • Berlin

MEHR

Our corporate partner is a software development company that has developed a software for electronic data capture in clinical trials. They provide innovative, e- Clinical Technology Solutions to contract research organisations (CROs) , scientific and academic research institutions and pharmaceutical [...] of a businessman and heart of a developer. Fluent or of a high- level of proficiency in both English and German. A Bachelor s degree in IT or life sciences; or equivalent years of experience. 5+ years experience in Product Management or similar role in Life Sciences or Technology. 3+ years of overall experience in software development. Experience working Agile. BENEFITS [...]
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Job vom 07.11.2024

Senior Scientific Project Manager

• Berlin

MEHR

[...] role, you will be working directly with our team and partners, i. e. , global pharma companies, biotechs, and academia, to define scientific research programs to be tackled by our AI model development teams, primarily in the areas of pre- clinical and translational research. To be successful in this role, you will need to navigate our diverse team of pathologists, biologists, [...] research programs all the way from scoping to successful and timely completion. We are looking for candidates who are passionate about doing high quality scientific research, with a relevant background in fields such as biology or pathology. Experience with clinical trials is a plus. Strong preference will be given to candidates that can be based in the Berlin area. At Aignostics [...] learning products. Coordinating the smooth day- to- day running of projects, including scheduling meetings, taking meeting minutes if needed, tracking relevant information and documenting progress. Preparation of content for scientific publications. Taking responsibility for relevant sections of our internal knowledge management systems. Coordinating work of junior team members. Qualifications: PhD in biomedical field or MD with specialization in pathology. Understanding of [...]

Job vom 07.11.2024 Director, Business Development- CE • Berlin Führungs-/ Leitungspositionen

MEHR

Candidates must be located in Central Europe Company Overview: Rx Logix is a global leader in pharmacovigilance solutions, providing innovative software and expert consulting services. Our team collaborates with Pharmacovigilance and Risk Management professionals to enhance compliance, productivity, and quality across the drug safety value chain. Dedicated to patient safety and the advancement [...] enjoy working on a high functioning, competitive, and collaborative team. Our Sales team is responsible for introducing our suite of solutions, to new customers and driving new business for the company in the US and Europe. Previous pharma experience and clinical trials experience is preferred. Software Sales Manager will play an important and highly visible role in liaising with key executives in [...]

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