Beschreibung
I am looking for a Freelance Senior Clinical Trial Leader who can support my client - a global pharmaceutical company based in Germany (near Frankfurt) - in a 8-14 months project.I am currently looking for an experienced Freelance Clinical Trial Leader who can support my client, a global pharmaceutical company based in Hessen/Germany, for the next 8-14 months.
This position includes the following tasks:
* Works effectively in a mixed environment and uses best practices and knowledge of internal or external business issues to improve products or services and to define processes and standards.
* Uses advanced analytical skills to solve complex problems or problems that do not have routine solutions and takes a new perspective.
* Has in-depth business knowledge and uses understanding of how relevant areas integrate to achieve objectives.
* Accountable to drive and monitor protocol related activities throughout the lifecycle of the project ensuring targets are met according to timelines, budget and quality expectations
* Drives protocol development process. Provides clinical, scientific and operational input into concept sheets and protocol (rational, objectives, design), Case Report Form, and other key protocol/program documents and activities
* Leads multiple cross-functional trial teams through start-up activities including study/site budgets and contracts, global geographic deployment (country/site identification, feasibility, selection), and country/site protocol approvals (MOH, IRB/EC) to study conduct, analysis and reporting
* Leads the execution of clinical phases of assigned global programs across all phases (Phase 1-4) including post-marketing commitments
* Acts as a central point of contact for communication between the team and the external partners, developing mitigation and resolution strategies, and promptly responding to action items
* Develops and leads the presentation on trial status to governance bodies and other relevant committees for deviations from budget and timelines as needed, highlighting issues and risks
* Applies clinical and scientific knowledge to prioritize the clinical data review and cleaning
* Drives oversight of CROs and vendor management at trial level according to the applicable partnership model
* Acts as functional lead for process improvement initiatives
* Understanding of trial feasibility elements
* Understanding of regulatory requirements across countries
* Impacts a range of important customer, operational, project or service activities within own team and other related teams that affect team performance and the way people work.
* Impacts others by providing advice, counsel or facilitating services in are
* Ensures trials for medium priority programs (eNPV ~ EUR m, expected peak year sales ~ EUR m, yearly development costs < EUR 20 m) are running according to plan and expectations, ultimately impacting timely and high quality delivery of program
* Leads execution of all operational trial activities across multiple trials, therapeutic areas, development phases and geographies
* Supports and provides input into sourcing strategy and implementation of partnership model with CROs
* Oversight of CROs at trial level ensuring high quality and timely delivery of portfolio
* Provides input to the concept sheet creation ultimately influencing country selection, study conduct and timelines
* Acts as functional lead for process improvement initiatives
Requirements:
* Advanced degree in Life Sciences (e.g., Biology, Chemistry, Pharmaceuticals) preferred or equivalent
* Requires a graduate degree (or equivalent) that provides knowledge of theories, principles and concepts within a discipline
* Extensive experience in all aspects of clinical trial planning and start up (including budget and resource planning), and in executing the complete range of clinical trial activities, from start up through final trial report
* Preferred five (5) years' experience in clinical research in CRO or a Pharmaceutical or Biotechnology Industry environment with at least three (3) of them in clinical trial management
* Proven track record of having successfully led one or more multinational trials
* Requires substantial professional experience (approximately 6-8 years as a guide)
* Requires very senior knowledge and experience in own discipline and beyond to supplement formal knowledge in order to apply principles and concepts of own discipline in resolving issues as they arrive
* Solid leadership skills and influencing skills
* Solid problem solving skills
* Fluency in English (oral and written)
* Position requires both domestic and international travel up to 30% of time
Start date: 1.11.2013
End date: 30.6.2014 (pot. extension until 31.12.2014)
Location: Hessen, Germany (near Frankfurt)
If you are interested in this position, please submit your updated CV to and let me know your availability for a telephone call so we can discuss all the details.
Also, if you could comment on the job description / requirements to give me an idea of how much you fit into this role, it would help me get a good first impression.
Please also let me know your hourly/daily rate.
I look forward to your response and to our phone conversation.
Kai Schröder
Real Staffing
Freelance Division
Tel.
Für mehr Informationen über Real, besuchen Sie www.realstaffing.com