Beschreibung
Hays ist ein weltweit führender Personaldienstleister, der sich auf die Rekrutierung von Spezialisten konzentriert - sowohl für den Projekteinsatz als auch für Festanstellungen und auf Zeit. In Deutschland, Österreich und der Schweiz vertrauen mehr als 600 internationale Topunternehmen auf unsere qualitätsgesicherten Prozesse, wenn Sie Experten suchen.We are looking for a
Clinical Trial Manager (m/f)
Referenz: -en
Beginn: asap
Dauer: 12 MM++
Ort: in Basel region
Branche: Sonstige Überlassung von Arbeitskräften
Ihre Aufgaben:
- Accountable for writing clinical protocols and related documents in collaborationwith the clinical trial team (CTT): lead clinical trial protocol development process; contribute to operational and scientific input given for development of trial-related documents and processes residing in other line functions
- Lead and matrix manage the global multidisciplinary CTT to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures
- Function as a Lead Clinical Trial Manager on studies for Full Development and assist in coordinating TM related submission documents
- Responsible for ordering and management of clinical trial materials, including drug supplies and CRFs
- Identify sites and manage study set-up, including responsibility for organizing and chairing the Initiation meeting
- Support the CRA on study related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects eligibility
- Responsible for set up and maintenance of the Trial Master File for assigned studies.
- Regularly update all trial information databases in order to manage accuracy of information
- Approve for all necessary center payments as per financial agreements.
- Lead the ongoing review of the clinical trial medical/scientific data (as needed), analysis and interpretation including the development of first interpretable results, clinical trial reports, publications and internal/external presentations
- Coordinate pre-audit activities for nominated projects ensuring a satisfactory outcome is achieved
- Contribute to identification and evaluation of new centers suitable for performing TM studies in healthy volunteer and patients
- Responsible for implementation of best practices and standards for trial management within TM, including sharing lessons learned
- Provide TM-SO expertise to other departments and line functions e.g. Drug Supply Management (DSM), through e.g. cross-functional working groups or TM Initiatives
- Contribute to talent and career development of TM staff through active participation in on-boarding, training and mentoring activities
Ihre Qualifikation
- Previous leadership of your own Clinical Trials
- Experience of more than one Phase within I/IIa/IIb/III
- Experience in Dermatology, Respiratory or Cardiovascular Clinical Trials
- Used to working within a medium to large international environment. Pharmaceutical experience preferred: CRO okay
- Successful full responsibility for your delivery in a multi-tasking matrix team
- Scientific credibility
- Good knowledge of drug development process
- A results-driven self-starter and decision taker
- A creative and innovative approach with a sharp and objective intellect, experienced in balancing big picture thinking with detailed analysis
- Strong cooperative team player, ability to be flexible and adapt to a changing environment
- A commercial outlook; used to helping a business achieve its objectives
- Well developed consultative interpersonal skills with good presence; experienced presenter & communicator, open, confident and persuasive, succeeding through influence
- Good project management skills: planning, prioritisation, problem solving and organisation
- Resilient, energetic and enthusiastic; responding constructively to new ideas and inputs
Skills:
- Clinical Project Management
Keywords: "clinical trial manager" and "clinical trial leader"