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Please take a few moments to read about some of the exciting worldwide career opportunities we have at Kendle, as well as the positive things our associates have to say about working for us.
Clinical Research Associate (CRA)
Auditor, advocate, and traveler – what a great job description! It’s how we see Kendle CRAs, our representatives at investigative sites around the world.
As a Kendle CRA, you could expect to work with principal investigators conducting clinical research studies to ensure that the study protocol is followed, as well as adhering to government agency requirements. In the US, you would travel to regional sites with an average of two to three overnight stays per week. Travel is not typically as frequent at Kendle's international locations.
In addition you would be responsible for completing project activities associated with monitoring functions of Phase I-IV clinical research studies while developing an understanding of the drug development process, Good Clinical Practices, and relevant regulations and operating procedures.
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"Kendle Chicago has a mix of great people that make coming to work fun. As a Lead CRA, there is a lot of variety, which keeps things interesting. I get to be involved with management of studies overall as well as getting to travel out into the field to interact directly with the investigators. There's never a dull moment!"
- Lead CRA, Kendle Chicago |
Project Leader (PL)
Could you take charge of a cutting-edge clinical project? Maybe handle more than one project at a time? Could you see yourself in a role that’s pivotal to the success of the company you work for? If your answers are yes, then maybe you should consider project leadership with Kendle.
This exciting role covers all aspects of managing projects and people, from proposal and bid defense, to managing your team through project implementation, then in oversight to project close. Depending on your previous experience there are opportunities to take on local, or global Phase I through Phase IV clinical research trials.
As a Kendle PL you would oversee and coordinate the operational aspects of ongoing projects, and work closely with a Group Leader to ensure the customer's goals of time, cost, and quality performance are met. In addition you would be expected to assure the quality and consistency of Kendle services according to all applicable regulatory guidelines, Good Clinical Practice and Standard Operating Procedures (SOPs) through direct line management support.
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"Kendle's project leaders are given the authority to make critical decisions, to train, mentor, and manage CRAs, and to interact and partner with large pharmaceutical companies in bringing their products to market. It is incredibly rewarding to be at the forefront of Phase I-IV testing of new drugs in therapeutic areas such as oncology, CNS, and pain management, and to witness the positive impact Kendle can have on the potential of these drugs to extend and improve the human experience."
- Clinical Project Leader, Kendle Cincinnati |
Biostatistician
Would you enjoy playing an integral part of designing and writing Statistical Analysis Plans (SAPs) for top pharmaceutical companies?
As a Kendle Biostatistician you’d have a varied role. A large part of your time would be spent with the process of protocol development. You’d become involved by choosing an appropriate study design including statistical methodologies, calculating necessary sample size to achieve a pre-specified power, and writing the statistical section of the protocol.
Some of the many other tasks performed by our Biostatisticians include:
- Review Case Report Forms (CRFs)
- Attend investigator/sponsor meetings and present statistical aspects of planned study
- Generate and review randomization schedule(s)
- Validate IVRS randomization implementation
- Write and review SAPs based on the protocol and develop organized, well-presented mock-up displays for tables, listings, and figures
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"It is very satisfying, personally and professionally as a biostatistician, being part of this great team of Kendle which contributes to generate the new knowledge, together with the pharmaceutical industry and the investigators, which make possible that new drugs can be used by millions of people around the world."
- Chief Statistical Officer for Latin America, Kendle Mexico |
Medical Writer
Clinical trials inevitably produce large volumes of clinical and scientific data. The task of our Medical Writers is to review and interpret all data.
Under the general supervision of the Medical Writing Manager, Medical Writers are responsible for interpreting the data, then incorporating it and their resulting conclusions into the appropriate document forms.
Another important aspect of a Medical Writer’s work is their responsibility for the quality control of data to ensure accuracy of the document and conformity to specific styles and formatting requested by our customers. To ensure the quality of the data being included in the documents they work closely with our customers and other Kendle departments as required.
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"Why do I love what I do? As a Medical Writer, much like in cycling, I enjoy working both autonomously and as part of a team -- engaging fully to exceed our clients' expectations down the road."
- Sr. Medical Writer, Medical Writing, Kendle Old Lyme  |
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