Clinical Trial Disclosure Manager
2 maanden geleden
Position Overview
At Genmab, we prioritize the transparency of clinical research. We understand the importance of sharing clinical trial data in a timely and unbiased manner to benefit patients and stakeholders alike. The Clinical Trial Disclosure & Transparency (CTD&T) team is an integral part of our Development Operations, which encompasses essential functions for the successful execution and reporting of clinical trials.
We are expanding our CTD&T team and are looking for a Manager to take on this pivotal role. This position offers engaging and evolving responsibilities, as well as the chance to collaborate with a team of dedicated and innovative professionals.
Key Responsibilities
- Oversee and ensure the public disclosure of clinical trial protocols, results, and document redactions.
- Create and manage timelines for protocol registration and results disclosure activities on relevant trial registries/platforms, collaborating closely with disclosure vendors as necessary.
- Author and supervise the creation of accessible results summaries.
- Develop and revise standard operating procedures (SOPs), templates, and manage the implementation of necessary systems and technologies.
- Provide training to internal staff and vendors on disclosure processes to ensure compliance with regulations.
- Stay informed on industry guidelines to ensure Genmab's adherence to best practices.
- Manage unsolicited requests through the designated communication channels.
- Represent Development Operations effectively in interdepartmental initiatives.
Qualifications
- A bachelor’s degree is required.
- A minimum of 5 years of experience in the pharmaceutical industry with a solid understanding of clinical development.
- Exceptional written and verbal communication skills are essential.
- Previous experience in clinical trial disclosure is highly preferred.
Personal Attributes
- A collaborative team player with a positive attitude.
- Results-driven and focused on continuous improvement with a proven track record of meeting deadlines.
- Strong organizational skills with the ability to prioritize effectively.
- A commitment to integrity, accuracy, and attention to detail.
- Dedicated to contributing to Genmab's overall success.
Work Environment
This role supports a hybrid working model, allowing for flexibility in your work environment. Genmab fosters an agile working atmosphere that enhances employee work-life balance. Our offices are designed to promote collaboration and innovation among employees, whether in our community-oriented spaces or while working remotely.
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