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Neue Perspektiven als Clinical Research Manager bei Advanz Pharma in Deutschland
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Advanz Pharma
Deutschland
Stellenausschreibung
Date: 7 Oct 2023
Location: DE
Company: AdvanzPharma
Job Title: Clinical Research Manager
Location: Germany, UK, Spain
About ADVANZ PHARMA
ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients’ lives by providing the specialty, hospital, and rare disease medicines they depend on.
Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with innovative biopharma and pharmaceutical development companies to bring medicines to patients.
Headquartered in London, UK, we have c700 employees based across more than 20 countries, including key countries in Europe, the US, Canada, and Australia. Our Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network complement our global operations.
ADVANZ PHARMA’s product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products and pipeline cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and, more broadly, rare diseases.
We can only achieve our ambition with the passion of our dedicated and highly qualified people, acting in line with our company values of entrepreneurship, speed, and integrity.
About the Role
The role of the Medical Office is to bring medical/scientific and drug safety related insights and expertise to ADVANZ PHARMA and to be subject matter experts across the following functional areas: medical affairs, medical compliance, patient safety, clinical development and post marketing research and medical operations. This entails engaging and collaborating with healthcare organizations, healthcare professionals and customers – both internal and external - and generating and communicating relevant, meaningful and impactful data. In so-doing, the Medical Office: represents the voice of the patient in all matters; works to ensure that products are supported by relevant, up to date data and retain a positive benefit/risk profile; helps to drive our scientific credibility and reputation as a company; enables stakeholders to make informed choices for patients; operates with due regard to all relevant regulations and compliance requirements.
The Clinical Research Manager will provide strategic assessment and input on the development program focusing on biological products to bring new products to patients in the most efficient way. The Clinical Research Manager will also identify, partner with and oversee clinical research/clinical development organization (CRO/CDO) as well as our partner development activities. This highly visible and influential role will involve exposure to Senior and Executive Management and requires an individual with a collaborative approach and the ability to link with and influence others.
What You’ll Do:
- Clinical study management scope includes mainly biosimilar studies (Phase I PK, Phase III Confirmatory Efficacy Studies) but involvement in any new product clinical development program (Phase III, Phase IV, Post Marketing Commitment) may be expected.
- Oversees the implementation of all activities related to assigned in house or partner clinical studies.
- Monitors, manages and reports clinical study timelines and provides progress reports to management.
- Responsible of developing and ensuring high quality documentation throughout the clinical study.
- Assists with the review and QC of study documents, clinical study data and reports.
- Oversee the preparation of clinical study reports and related manuscript publication
- Support the preparation of Scientific Advice briefing documents for biosimilar products and clinical elements of regulatory submission documents for Health Agencies.
- Provide support and guidance to the BD&L Team when evaluating new projects and M&A by conducting dossier due diligence.
- Responsible for selection and management of CROs and vendors for outsourced clinical study activities including monitoring, data management, statistics, etc.
- Creates clinical study budget and manages budget including verification of invoices associated with outsourced activities
- Conducts site feasibility assessments, site initiation visits, interim monitoring visits and close-out visits as required.
- Identifies and escalates, where necessary, instances of non-compliance, company risk or exposure, or safety risks to study participants. Collaborate to process impro
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