Manager Medical Study Operations

Regeneron; Deutschland; Vor Ort; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Manager for Medical Study Operations in Onco-Hematology. In this pivotal role, you will lead operational activities for Externally Sponsored Research, ensuring compliance and effective collaboration with medical teams. Your expertise in IIT study operations and project management will be essential as you navigate the complexities of study start-up and execution. This role offers the chance to make a significant impact in a dynamic environment focused on health innovation. Join a diverse and inclusive culture that values creativity and initiative, and take the next step in your career with this exciting opportunity.

Leistungen

health and wellness programs

fitness centers

equity awards

annual bonuses

paid time off

Qualifikationen

• 7+ years in health compliance roles within the pharmaceutical industry.
• Deep expertise in managing IIT studies within Onco-Hematology.

Aufgaben

• Lead operational activities for assigned projects including study start-up and timelines.
• Collaborate with medical directors to ensure studies are on track.

Kenntnisse

IIT study operations

communication skills

project management

problem-solving

Ausbildung

BSc

Tools

document repository systems

Jobbeschreibung

At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work across our growing global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to approach science, manufacturing and commercialization. And new ways to think about health!

Manager, Medical Study Operations, Onco-Hematology - Munich

As a key member of the Medical Affairs team, you will serve as an important liaison between Regeneron and the scientific and healthcare community.

As Manager, Medical Study Operations (MSO) - you will be responsible for leading operational activities across assigned projects including study start-up activities, timelines, budgets and reports in support of Externally Sponsored Research (ESR) including Investigator-Initiated Studies Programs, Collaboration Studies, and Managed Access Programs, led by Medical Affairs, while ensuring compliance standards are met.

A typical day may include:

• Working collaboratively with medical directors and team members to ensure study(s) are on track according to timelines, issues are identified and escalated appropriately, and deliverables are clearly communicated.
• Managing study start-up, maintenance, and closeout of studies.
• Maintaining Essential Document - ensures all appropriate documentation in support of a proposal has been collected and filed correctly within the document repository systems on an ongoing basis.
• Coordinating Pharmacovigilance Compliance activities - IAL distribution and appropriate tracking of receipt and delivery, and/or SAE reconciliations.
• Managing Drug Supply, budget, metrics & reporting, meetings & committees & processes.

This role may be for you if:

• You enjoy working autonomously in the field while making an impact on the company's mission.
• You can communicate and act promptly, demonstrating initiative, creativity, and efficiency in sophisticated, rapidly changing environments.
• You have good knowledge in managing IIT studies within the field of Onco-Hematology.
• You enjoy collaborating with the team and establishing relationships with internal & external partners.
• You can lead multiple initiatives, prioritize them, and implement them independently.

To be considered for this role, you must hold a BSc, and you have a deep expertise & a proven experience in IIT study operations. You are a passionate Study Operations Expert with at least 7+ years in health compliance roles within the pharmaceutical industry.

You are a collaborative Manager with a high degree of partnership, with the ability to get along with cross-functional teams and work independently. Creative Problem-Solver, you are comfortable making decisions & designing creative solutions to support the development of strategies and implementing solutions swiftly. Proficiency in English is required, German is highly desirable, and any other European language is a plus.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.

The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.