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Assoc. Mgr, Clinical Research

Covance 7/2/2018 2:28:20 PM
JOB ID: 21667 Category: Client Services
Regional, Israel

   

 

Job Overview

You would be working within our Flexible Solutions department dedicated to one sponsor/client.

Would you like to work for one of the best known big pharma companies? Our sponsor is a global mid sized pharma company with high working standards. Are you passionate about growing in Clinical Field? We are proud to have an excellent team of the best professionals on the market and are looking for people who are ready to show true performance and interest in Clinical Trials. Do you like responsibilities and challenges? As a Clinical Research Associate you will lead all aspects of study site monitoring according to Covance SOP, ICH guidelines and GCP. You will take part in pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files.

You will become a part of our team who is always ready to help. We offer a home based position so you will not spend time on unnecessary travels but at the same time we highlight a true live relationship between colleagues. You will have a possibility to devote all your professional skills and knowledge into monitoring investigational sites as we organize our work environment and responsibilities with high standards.

Our sponsor invests heavily in training and crafts modern system of Clinical Trials so if you are passionate about working with a phenomenal team and expand your horizons feel free to reach us.

Responsibilities:

* PERFORMANCE: Accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally. 30%
* MANAGEMENT: POC for assigned protocols. Pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments for assigned protocols. Strong collaboration with local CO roles. Forecasts country resource needs. Serves local business needs (signs contracts, manages budgets as delegated). 20%
* QUALITY OVERSIGHT: Responsible for quality and compliance in assigned protocols in country. Oversees CRAs and CTCs on assigned projects. Oversees training compliance. Performs quality control visits. Reviews Monitoring Visits Reports and escalates performance issues and training needs to functional vendor and internal management as needed. 20%
* EXTERNAL CUSTOMER FACING: Responsible for collaboration with functional outsourcing vendors, investigators, other external partners. Oversees country and site validations, site selection and recruitment in assigned protocols. Responsible for clinical trial education to sites. Country POC for programmatically outsourced trials for assigned protocols.20%
* INTERNAL COLLABORATION & STRATEGY: Collaborates internally with local PV, Regulatory, GMA/GHH to align on key decisions in countries. Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD and Regional Operations.10%

Education / Qualifications

* University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology
* In lieu of the above requirement, candidates with minimum of four (4) or more years of relevant clinical research Experience in pharmaceutical or CRO industries or Experience in a health care setting will be considered
* Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
* Thorough understanding of the drug development process
* Fluent in local office language and in English, both written and verbal

Experience

* Good organizational and time management skills
* Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project team and investigative sites preferred.
* Excellent communication skills, oral and written.
* Self-motivation with the ability to work under pressure to meet deadlines
* Works well independently as well as in team environment.
* Detail and process oriented
* Positive attitude and approach
* Interact with internal and external customers with high degree of professionalism and discretion
* Multi-tasking capability.
* Good computer skills with good working knowledge of a range of computer packages
* Ability to lead and develop junior staff
* Flexible and adaptable to a developing work environment
* Minimum of four-six (4-6) years of clinical research Experience


Position Type: Full-Time

Location: Regional, ISR - Israel



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Covance Recruiting Process

Below is a general Overview of Our Recruiting Process

If you’d like to work for us, please submit your resume/CV online. If your ability to use or access our electronic application is limited due to a disability, please visit www.gettinghired.com or call 1-800-978-4473 for help.

We consider applications from everyone who is interested in a position with us and who meets the required criteria and qualifications.

If your application is selected, someone from our recruiting team will contact you to arrange an initial screen. We may carry this out over the phone or at a face-to-face meeting. You must complete the screen to be considered for the position.

Based on the results of the initial screen, we may invite you to an interview. One of our recruiting team members will contact you to arrange this. The process may involve several interviews, initially over the phone, and then face-to-face with different members of the hiring team.

Our interviews follow a behavioral-based format. This means we’ll ask you to give us information that’s specific to your professional and educational experiences.

Hiring team members will share and discuss their input and then make their decision.

If you’re the person who best meets the requirements of the position, a member of the hiring team will get in touch to make you an offer of employment. Covance is an eVerify employer (United States only).