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Senior Clinical Business Process Manager

Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients.

Locations: Copenhagen

The Role:

If you are looking for the next step in your career and you have process development and systems experience, and you want to have influence on how Genmab operationalizes trials in the future, then you might be our next colleague to join Clinical Operations!

As Senior Clinical Business Process Manager, you will represent, support, and collaborate with all functions within Clinical Operations. It is expected that you drive the transformation of Clinical Operations with a strong focus on optimizing the way we work to ensure compliant, high quality, and efficient processes across all trial phases and functional areas.

You will work in close collaboration with the Clinical Operations Leadership Team (COLT) and Extended-COLT and Clinical Oversight Lead (COL) ensuring that the processes within Clinical Operations are compliantly anchored in the overall departmental strategy.

Responsibilities:

In this role, you will drive strategic and operational optimization projects within the department and setup workshops and lessons learned with internal and cross-functional stakeholders, vendors, and strategic partners to continuously map and optimize processes within Clinical Operations. You will support compliance and risk management initiatives and drive input to various systems/dashboards/applications to support oversight activities and data visualization within the department.

Furthermore, you will work closely together with various stakeholders to drive the development and evaluation of quality measurements within the department. Also, you will act as a subject matter expert on behalf of Clinical Operations and may be responsible for supporting the development, writing, and review of Genmab standard processes (SOPs), procedures and guidelines, and templates together with R&D Clinical Development.

In collaboration with key stakeholders, you will support inspection readiness for internal audits and Health Authority inspection activities ensuring Clinical Operations’ preparedness and compliance and support team members in connection to inspection/audit not limited to: development of inspection/audit material, participation and presentation during audits/inspection, respondingto audit and inspection findings. Lastly, you will participate in/drive relevant departmental activities as applicable, eg, due diligence activities, scientific forums/workshops/learnings, lead/contribute to knowledge sharing sessions, participate in the development and implementation of new methodologies and procedures to ensure Clinical Operations’ work is of high quality and in compliance with processes.

Your position will bring a high level of visibility in the organization, as you will collaborate with several key stakeholders across Clinical Development to ensure focus on process work through continuous stakeholder management and communication. The successful candidate will have strong analytical skills, high quality standards, and a track record of meeting deadlines. In addition, it is essential the candidate is well-organized, proactive, and flexible, and has the ability to work on multiple tasks simultaneously. Furthermore, you thrive working in an international environment, characterized by on-going changes of procedures, systems and processes.

Requirements:

Preferably prior experience as a process manager or consultant in implementing and anchoring operational excellence initiatives within the pharmaceutical industry

– Experience with process optimization
– +5 years pharmaceutical industry experience
– Experience within clinical trials is preferred, but not required
– Good understanding/knowledge of regulatory requirements and drug development processes, GCP/GXP, regulatory requirements, and guidelines associated with regulatory documents
– Excellent stakeholder management skills
– Highly organized with the ability to manage multiple conflicting deadlines and competing priorities
– Experienced in driving change and facilitating cross-functional workshops
– You can work independently, with a positive, can-do-attitude
– Demonstrate a structured and analytical approach
– Enthusiastic and comfortable cooperating and communicating across different functional roles
– Proficiency in the use and understanding of computer software e.g. word processing, graphics, and document management systems

You meet the following personal requirements:

– Capable of working on multiple tasks and shifting priorities, and leading cross-functional teams under strict timelines
– Motivated and detail-oriented
– Have the ability to work across all trial phases and prioritize your own tasks
– Dedicated team player and a great communicator with excellent oral and written communication skills
– Proactive and open-minded
– Have a quality mindset and thrive in a fast-paced and changing environment
– Result- and goal-oriented and committed to contributing to the overall success of Genmab

Genmab will offer a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural environment, with an aim to make a difference in the lives of people with cancer.

At Genmab, we pride ourselves on our unique culture. We are committed to make a positive impact on the lives of cancer patients. We hypothesize and experiment to seek innovative solutions, no matter the employee’s role; we speak up, empower each other, and embrace change and growth; we respect and celebrate our differences while working as one team. Teamwork and respect are central pillars of Genmab’s culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. Genmab employees work with determination, challenge the status quo and cultivate a growth mindset in everything we do.

We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability or genetic information.

We look forward to hearing from you!

To learn more about the position contact Nina Skyum at, nina.skyum@pharmarelations.dk or Louise Brinking, at louise.brinking@pharmarelations.dk

Applications will be handled continuously, so apply today!

Read more about Senior Clinical Business Process Manager here!