Are you looking for the next step in your career, have process development experience, and want to have influence on how Genmab operationalizes trials in the future?

As a Clinical Trial Process Manager, it is expected that you help 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 Clinical Oversight Lead (COL) ensuring that the processes within Clinical Operations are anchored in the overall departmental strategy.

The Clinical Trial Process Manager will join a highly skilled team in DK or US and report to Senior Director, Head of Medical Writing & Clinical Trial Processes.

Responsibilities

The key responsibilities for this role will be, but not limited to:

• Drive several optimization projects within the department, setup workshops and lessons learned with internal stakeholders, vendors, and partners to continuously map and optimize processes within Clinical Operations
• Support regular departmental risk management review meetings with the Clinical Oversight Lead and give input to various dashboards/applications to support oversight activities within the department
• Furthermore, you will work closely together with various stakeholders to drive the development and evaluation of several quality measurements within the department
• Finally, it is expected that you will support process training needs at the department level

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 several years of 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

Moreover, you meet the following professional requirements:

• You are capable of working on multiple tasks and shifting priorities and leading cross-functional teams under strict timelines
• You are motivated and detail oriented
• You have the ability to work across all trial phases and prioritize your own tasks
• You are a dedicated team player and a great communicator with excellent oral and written communication skills
• You are proactive and open-minded
• You have a quality mindset and thrive in a fast-paced and changing environment
• You are result- and goal-oriented and committed to contributing to the overall success of Genmab

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. We believe that fostering workplace diversity across social, educational, cultural, national, age and gender lines is a prerequisite for the continued success of the company. We are committed to diversity at all levels of the company and strive to recruit employees with the right skills and competences, regardless of gender, age, ethnicity, etc.