Clinical Research Associate II
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POST DATE 9/7/2016
END DATE 10/20/2016
JOB DESCRIPTIONFOR US, ITS A MISSION
At Mylan, we mean it when we say we work every day to provide access to high quality medicines to the worlds 7 billion people. If you are unconventional, relentless and passionate. If you believe in doing whats right, not whats easy. If you are a doer and have a passion for serving others, we want to talk to you.
MAKE A DIFFERENCE
At Mylan, each person has the ability to make a difference. From the providers who sell and market our products to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role. Heres how this role will help:
* Project lead between the Mylan project team (PKDM Department, Product Development Department Chemistry Department, Quality Assurance Department, Mylan affiliate companies and various BD partners), clinical investigators and contract vendors for standard and complex bioequivalence studies.
* Site Manager for 3-4 Bioequivalence (BE) established and new CROs with responsibility to oversee all projects assigned to that CRO. Train new CROs and ensure established CROs are compliant with all study protocols, overall clinical objectives, FDA, ICH and other regional guidance and regulations, internal SOPs and Mylan departmental policies and SOPs. Maintain all required regulatory study documents, monitoring records and correspondence confidentially and in accordance with Mylan document control procedures for each project.
* Review all clinical and drug product documents for accuracy, completeness and timeliness internally and at the research sites. This includes review of Regulatory Documents, Drug Release/Accountability paperwork, Source Document templates, Case Report Form templates, Informed Consent Forms, Adverse Events, Dosing Logs, Protocol Deviations and Clinical Reports.
* Conduct clinical monitoring of studies remotely and on-site as required according to Mylan Standard Operating Procedures (SOPs). This includes visit preparation, monitoring process, completion of the monitoring report, visit follow-up activities and travel to and from the clinical locations.
* Interview clinical site research personnel in follow-up of monitoring visits and data issues. Communicate any substantial findings to his/her Supervisor during or immediately following a monitoring visit. Monitor and/or follow-up on the implementation of corrective action plans following clinical site inspections or audits, as required.
* Assist in management of patient trials and clinical endpoint CRO services related to site management and monitoring functions to include co-monitoring as needed.
MAKE OUR VALUES YOUR VALUES
Mylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude. People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care. Here are the minimum qualifications and essential functions for this position:
* Minimum of a Bachelor's degree (or equivalent) and 2-4 years of experience in the field or related experience. However, a combination of experience and/or education will be taken into consideration.
* Certification (i.e., ACRP) as Clinical Research Associate preferred, but not required.
* Must possess knowledge of project management skills and pharmaceutical industry. Knowledge of and understanding of Good Clinical Practice and other associated regulations, guidelines and industry standards for clinical trials is required. Knowledge of medical terminology is desired.
* Must possess excellent oral and written communication skills. Good organization skills, attention to detail, ability to work as part of a team and the ability to manage multiple tasks is required. Must possess planning skills for a range of 6 months to 2 years in advance of study deadlines. Should be proficient in PC applications (Excel, Microsoft Word, etc.). Should have the ability to read and interpret documents. Ability to write routine reports and correspondence. The successful candidate must maintain a high level of professionalism and personal integrity.
* Ability to perform computations such as percentages, ratios, and rates. Ability to understand simple statistical analyses
* Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.
* Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with groups of people such as other departments and communicate known concepts. Ability to present to a group or department.
* 30% travel is required to include extended international travel.
* Proficiency in speaking, comprehending, reading and writing English is preferred.
If you want to be part of a global health care company that is making a difference and changing lives, Mylan may be the place for you. With a workforce of more than 30,000 worldwide, we can make a difference. We encourage you to visit Mylan.com to learn more about our unconventional culture, our approach to doing business and how we plan to set new standards in health care.
Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. All qualified applicants will receive consideration for employment without regard to their disability or protected veteran status. Mylan is an Equal Opportunity Employer, Minorities/Female/Disabled/Veteran.
Job Posting: Sep 6, 2016, 3:40:05 PM
Unposting Date: Ongoing.