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Novartis Institutes for BioMedical Research - Switzerland
Clinical Trial Leader (CTL) I
Location: Basel,
Switzerland
00000
Posted on:
10/12/2009 1:05:35 PM
Postion type:
Full time
Job Code:
56886BR
Required Education:
Bachelor's Degree
Salary:
DESCRIPTION
You will be responsible for planning and implementation all operational aspects of the Translational Medicine (TM) studies you're in charge of (e.g. medium to high complexity studies; first in man, patient studies, multi-center studies, mechanistic studies) from synopsis to reporting according to timelines, budget, operational and quality standards (ICH/GCP/Novartis SOPs and procedures). Typically managing between 2-4 studies at the same time, this is an important role interfacing between Research and Development, helping to guide what should progress forwards into development.
MAJOR ACTIVITIES:
1. Accountable for writing clinical protocols and related documents in collaboration with 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.
2. Lead and matrix manage the global multidisciplinary CTT to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures: chair CTT meetings (as needed), report study progress and issues to CTT and Management; lead trial level interactions with internal line functions and external CROs e.g. those providing monitoring and site management services.
3. Function as a Lead CTL on studies for Full Development and assist in coordinating TM related submission documents.
4. Responsible for ordering and management of clinical trial materials, including drug supplies and CRFs.
5. In collaboration with CRO management, CTT and CRAs, identify sites and manage study set-up, including responsibility for organizing and chairing the Initiation meeting.
6. Support the CRA on study related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects eligibility.
7. Responsible for set up and maintenance of the Trial Master File for assigned studies.
8. Regularly update all trial information databases in order to manage accuracy of information.
9. Approve for all necessary center payments as per financial agreements.
10. In collaboration with the TME and CTT, 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.
11. Co-ordinate pre-audit activities for nominated projects ensuring a satisfactory outcome is achieved.
12. Contribute to identification and evaluation of new centers suitable for performing TM studies in healthy volunteer and patients.
13. Responsible for implementation of best practices and standards for trial management within TM, including sharing lessons learned.
14. Provide TM-SO expertise to other departments and line functions e.g. Drug Supply <BR> <BR>Management (DSM), through e.g. cross-functional working groups or TM Initiatives.
15. Contribute to talent and career development of TM staff through active participation in on-boarding, training and mentoring activities.
Some short business trips should be expected, probably around 6 trips a year lasting a couple of days each
Number of Associates:
Typically 3-5 cross-functional members from TM and sister functions per study
Indirect Responsibility:
Authorize study payments according to financial contract.
Impact on the Organization:
Internal - Responsible for the availability of high quality, clinical pharmacology data according to agreed timelines and budget to enable no delays in decision making and drug registration.
External - Novartis perceived as a reliable business partner.
REQUIREMENTS:
EDUCATION:
BSc or MSc in life sciences or nursing, PhD level scientist with life sciences background, or PharmD.
LANGUAGES:
Fluent English (oral and written), knowledge of a second language desirable.
EXPERIENCE:
* Gained relevant experience in Translational medicine, Clinical Research or Research Nurse experience (CRO, academic institution, hospital or industry)
* Potential to cope with scientific aspects and operational tasks in a multidisciplinary organization (teamwork)
* 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 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
EOE.
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