Clinical Project Manager
- Employer
- Hobson Prior
- Location
- Switzerland (CH)
- Salary
- CHF 125,000- CHF 130,000
- Start date
- 19 Mar 2019
- Closing date
- 17 Apr 2019
View more
- Discipline
- Clinical Research, Clinical Operations
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Management
Job Details
Hobson Prior are currently looking for a Clinical Project Manager for an exciting position based in Switzerland. Our client is a clinical stage biopharmaceutical company focused on advancing modern medicine and improving the management of serious disease. In this role you will be responsible for operational planning and management of clinical trials.
Job Responsibilities:
- Lead the clinical study team and manage trial budget.
- Manage the interfaces and definition of operational specifications for MPAG vs clinical research vendors.
- Develop clinical outsourcing specifications to facilitate bid templates and selection of clinical research vendors.
- Guide the development of standard processes, planning and resource management tools and performance metrics to achieve excellence in clinical program management.
- Involvement with the development of clinical sections of regulatory documents, such as IBs/briefing books/safety updates/CTA/BLA submission documents and responses to Health Authority questions.
- Development of relevant sections of clinical study protocols and related documents in collaboration with CROs; development of study tools, guidelines, and training materials, management of clinical study material, and implementation of issue resolution plans.
- Ensure administrative/operational monitoring of clinical studies.
- Daily interaction with the CRO, third party vendors and study sites to ensure sponsor’s oversight responsibilities.
- Ensure all trial deliverables are met according to timelines, budget, operational procedures and quality/GCP standards.
- Making sure maintenance of Trial Master File in strict compliance with ICH/GCP and internal SOPs.
Requirements:
- Degree or equivalent education within life science/healthcare.
- Minimum of 5 years of experience in clinical trial execution in a biotech or pharmaceutical company or contract research organization.
- Knowledge of the international aspects of drug development process, including knowledge of international standards (GCP/ICH), health authorities (FDA, EMA), local/National Health Authority regulations
- Demonstrated track record of managing a clinical trial from setup to clinical study report (including setup of eCRF, IVRS/IWRS, laboratory related tasks, etc.)
- CRO and site management capabilities with demonstrated ability to solve problems and mediate potential compliance issues
- Proficiency in English, German is desirable.
Apply now:
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
Company
Providing recruitment solutions across the life sciences industry
Hobson Prior is a leading specialist life sciences recruiter focused on finding and placing outstanding candidates across Europe and the Asia Pacific. We work proactively and with integrity, communicate in a professional and honest manner and invest time to understand and match the exact requirements of our clients and candidates.
Our highly selective clients trust us to source and secure interim and permanent candidates who’ll make a real difference to the success of their business. Our candidates, the best in the industry, often choose to work with us exclusively because we offer the best opportunities in their specialist field.
Representing who we are and what we stand for, our values influence the way we serve our clients and candidates and the way we interact with each other.
We identified them collaboratively – as a team – and so feel 100% invested in them. Together, we think they provide the best possible outcomes all who work with us.
Professional
Our standards are set high. We work to a rigorous set of processes to ensure that our conduct is professional, ethical and delivered with integrity at all times.
Dedicated
We are dedicated to finding the very best solutions for our clients and candidates, always going the extra mile to deliver measureable value.
Experienced
We are guided by our experience and knowledge to provide the best possible service and support to our candidates, clients and colleagues. Our approach is consultative and collaborative.
Specialist
We focus solely on our chosen market, developing expert consultants who know their industry in depth and specialise within it.
Proactive
We find great candidates, developing relationships with them regardless of whether they are actively looking. This means we are able to provide both candidates and clients with unique opportunities.
Ambitious
Driven by results, we have plans to expand across different global regions and markets and have confidence in our ability to grow successfully through our core focus.
- Website
- http://www.hobsonprior.com/
- Telephone
- 01892 612 612
- Location
-
Wellington Gate
7-9 Church Rd
Tunbridge Wells
TN1 1HT
United Kingdom
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