[I79] Kr hp non:interventional Study Specialist

[I79] Kr hp non:interventional Study Specialist

Through this tool you may choose to activate/deactivate single Technologies used on this website.. Optimization. As an employer we are responsible for our work and our people.. We're proud to be one of the 20 leading pharmaceutical companies in the world and a global leader in animal health and biopharmaceuticals.. We proudly weave diversity and inclusion into the fabric of who we are.. Our headquarters are in Ingelheim, Germany, and we have 176 affiliates worldwide with around 50,000 employees.. We understand that when you grow, so do we. Join us to collaborate, innovate, grow and improve lives. Since 125 years our work is founded on profound research and innovative development..

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KR_HP_Non:

Interventional Study Specialist (2115019). Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment which benefits our employees, patients and communities.. KR_HP_Non:

Interventional Study Specialist:

2115019. OUR COMPANY. At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and family:

owned ever since, Boehringer Ingelheim takes a long:

term perspective.. Now, we are powered by 52,000 employees globally who nurture a diverse, collaborative and inclusive culture. We believe that if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve.. Lead for medical projects with ownership,

such as regulatory PMS, observational studies, compassionate use programs and investigator:

initiated studies according to applicable local regulation, GxP guideline and internal SOPs. Tasks and responsibilities. Responsible for oversight, management, and operational activities in line with GxP and other applicable regulations. Leading the projects ( rPMS, OS, CUP, IIS ) in planning, conduct, completion and local reporting. CRO selection and contract according to relevant SOPs and maintain / oversight CRO to carry out project operation efficiently. Establish and monitors project budget aspects including investigator fees and CRO payments. Interactions with local regulatory authorities and IECs/IRBs for initial, regular reporting in cooperation with CRO if applicable. Adherence to GxP and other local and global regulations, company SOPs,

local working instructions and role specific traiinng relevant to the operational conduct of studies. Responsible for managing all required local study documents including final archive with collaboration with relevant functions such as medical affairs, regulatory affairs as applicable. Requirements. At least 5 year:

experience in non:

interventional studies, preferably in the pharmaceutical/ CRO industry including project management. Good project management skill and with leadership capability, ability to work independently and a part of a team. Highly committed to timelines and delivery of maximum quality data. Excellent communication and interpersonal skills and good English skills (both spoken and in writing ). Basic understanding of Statistics (basics of study design, and tests used ) and pharmacokinetics. Prompt responsiveness,

outstanding ability to cope with multiple requests and to work under time pressure. Proficiency in all common office software and smooth self:

training of new software programs / All pre:

requisition for CRA should be met. WHY BOEHRINGER INGELHEIM?. With us, you can grow, collaborate, innovate and improve lives.. We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In additio

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