Senior Manager, Clinical Study Management
A global and innovative healthcare company is currently hiring for a Senior Manager, Clinical Study Management position. The company is focussed on the development of innovative products and medical devices that address high unmet medical needs. There are over 400 employees and the company continues to grow. Based in Germany, this is an exciting opportunity to bring expertise and skills to an in-demand company that is creating new products for better health worldwide.
- Providing clinical operations oversight in the identification, evaluation, and selection of CROs, outside vendors (e.g., central labs, Ethics Committee, IWRS, etc.), and investigative sites.
- Participating in CRO partnership activities to ensure smooth operationalisation, running and completion of clinical study/studies.
- Establishing communication flow with CRO and investigative sites to maximize compliance with study protocol.
- Developing protocol outlines, protocols, amendments and CRFs.
- Coordinate budgeting, timelines and vendor selection for the implementation of clinical study/studies.
- Acting as operational lead for a study or studies/program.
- Ensuring studies are conducted in accordance with all applicable legal and regulatory requirements.
- Managing recruitment efforts and activities to meet study enrollment goals and timelines.
- Managing, coordinating, and providing ongoing assessment, evaluation, and communication with internal and external stakeholders, other Avanir departments (e.g., Regulatory, Drug Safety, and Clinical Trial Materials) and external vendors (CRO, consultants, etc.) to ensure study objectives/timelines are accomplished.
- Supervising clinical team to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; ICH GCP, and Avanir SOPs.
- Managing and facilitating development/review of all critical clinical study documents, including clinical protocols, informed consent forms, or other study-related clinical documents (e.g. Study Plans, Case Report Forms, Source Documents, Monitoring Plans, Data Management Plan, Project Management Plan, etc.)
- Providing management personnel with timely updates on progress and changes in scope, schedule, and resources as required.
- Operational oversight that serious adverse events (SAEs) and follow-up reports have been reported to the regulatory authorities and ethics committees in accordance with regulatory requirements.
- Operational oversight to ensure that all clinical study documentation (such as TMF) are up to date and comply with all appropriate regulations.
- Participating in forecasting study expenditures and resourcing needs; ensuring internal clinical team and vendors manage and monitor study-related budget and expenses to meet forecast and provide timely communication of any variances in budget forecast to the Clinical Department Head.
- Representing OEDC Clinical at internal company meetings as required.
- Engaging in Inspection readiness strategies and activities.
Skills and Requirements:
- Minimum of Bachelor's degree in pharmacy or equivalent.
- At least 12+ years of experience in the pharmaceutical/biotechnology industry, including experience with IMP requirements.
- 5+ years demonstrated work experience of successfully managing clinical trials within the pharmaceutical industry, including CRO and contract vendor management, preferably in the CNS therapeutic area.
- Experience in management of international or global clinical trials required.
- Knowledge of GCP and regulatory requirements and GMP relating to Clinical Research.
- Thorough understanding of Clinical Development Processes.
- Ability to plan and execute a clinical trial from an operational perspective.
- Experience in clinical site monitoring.
- Experience in development of essential clinical study documents, including informed consent, monitoring plans, source documents, Case Report Forms (CRFs), study recruitment plans, etc.
- Experience in protocol development/writing.
- Both working and theoretical knowledge of ICH GCP, clinical trials management with exposure to various phases of drug/trial development life cycle preferred (e.g., Phase I- IV, start-up through close-out), scientific methods, research design, regulatory compliance, and clinical data management.
- Ability to supervise, direct and lead team members as well as interact with other internal staff.
- Financial management skills as applicable to oversee project expenditures.
- Possess advanced computer skills (Microsoft applications, spreadsheets, etc.)
- Cross-functional and cross-cultural awareness.
- Fluent in written and spoken English.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Nico Kohlwes at email@example.com or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.