Senior Manager, Clinical Research Transparency

2 weeks ago


Trenton, New Jersey, United States Genmab AS Full time

About Genmab
Genmab is a pioneering biotechnology firm dedicated to enhancing patient lives through innovative antibody therapies. With over two decades of experience, our dedicated team has developed advanced antibody technology platforms and utilized translational research to create a robust pipeline of therapeutic solutions.

Position Overview
We are seeking a Senior Manager for Clinical Research Transparency to join our expanding Clinical Trial Disclosure & Transparency (CTD&T) team within Development Operations. This role is essential in ensuring compliance with global and national clinical trial disclosure mandates across our diverse portfolio.

Key Responsibilities
- Lead and oversee the public disclosure of clinical trial protocols and results, ensuring meticulous redaction of documents.
- Collaborate closely with trial teams and relevant departments to guarantee high-quality outputs and responsible dissemination of clinical trial information.
- Develop and maintain timelines for protocol registration and results disclosure activities across various trial registries and platforms.
- Author and supervise the creation of clear, accessible results summaries.
- Update and refine standard operating procedures (SOPs) and templates, while managing the implementation of necessary software solutions.
- Provide training to internal staff and vendors on disclosure processes to ensure adherence to regulatory standards.
- Monitor industry guidelines to ensure Genmab's compliance with evolving transparency requirements.
- Manage unsolicited requests and represent Development Operations in cross-departmental initiatives.

Qualifications
- A minimum of a bachelor’s degree.
- Over 5 years of experience in the pharmaceutical sector, with a solid understanding of clinical development.
- Exceptional written and verbal communication skills.
- Previous experience in clinical trial disclosure is highly desirable.

Personal Attributes
- A collaborative team player with a positive outlook.
- Goal-oriented with a proven track record of meeting deadlines.
- Strong organizational skills with the ability to prioritize effectively.
- Committed to maintaining integrity, accuracy, and attention to detail in all tasks.

Work Environment
This position offers a hybrid working model, allowing for flexibility and a balanced work-life integration.

Our Commitment
At Genmab, we value diversity, equity, and inclusion, and we are dedicated to fostering a workplace that reflects these principles.



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