At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

The Role & Department

The Clinical Trial Assistant (CTA) is responsible for filing of documents (eTMF) to ensure inspection readiness at trial level as directed, by supporting Global Clinical Trial Management (GCTM)/Clinical Trial Management (CTM) & supporting GCTM/CTM in Development Operations with administrative activities.

Working in Development Operations is exciting, challenging, and fun at the same time. The dedication, collaborative and knock-your-socks-off spirit of our employees are what really shapes our team. From Day One, the onboarding program makes sure that you accomplish trainings, get settled with our IT systems, and team up with your mentor, colleagues, and relevant stakeholders.

Key responsibilities

eTMF Management:
Setup, maintain and close Sponsor eTMF (trial, country, sites, EDL, upload of document).
Proactive review of eTMF (TMF-Browser, Monthly Review (Docs In Progress, EDL), eTMF Spot Check, review of classification as needed).
Support, as needed, to resolve any inconsistencies identified during routine checks and filing.
Audit/Inspection readiness preparation.


Meeting and Communication Management:
Coordinate logistics for internal and external meetings, including but not limited to the Clinical Trial Team (CTT) meetings (emails in connection with the mtg, filing in eTMF, invites, recording, etc.).
Prepare agendas and write meeting minutes.
Coordinate logistics for Oversight Dashboard (ODB) Review meeting (run reports, invites, emails in connection with the mtg, filing in eTMF incl workflow).
Provide Clinical Trial Governance (https://clinicaltrails.gov) site and status updates.
Support QC and development of graphical presentations, etc.


Plans and Resource Management:
Maintain CTT staff list in GenTrack/GenSense.
Maintain Vendor list in GenTrack/GenSense.
Setup and maintain CTT Charter.
Support CTM in reviewing TMD and Portfolio App in GenSense.
Provide input to Trial Oversight Plan.
Provide input to TMF Plan.


Other core activities:
Support handlingof site contracts, ongoing updates of the trial dashboard, trial budgetmaintenance and development.
Support filing appendices of Clinical Study Report (CSR).
Support inspection preparations.


Requirements - what you must have
Completed high school diploma or equivalent education.
Some experience in administration, customer service, or related field preferred.
Demonstrated proficiency in written and oral English communication.
Experience of working with tools like Microsoft Office, Microsoft Teams, SharePoint, etc. and experienced in using IT systems.
Well-organized and structured, with a sense of attention to detail.
Can work in an environment with many competing priorities.
Service mindset.
Able to work independently as well as in global teams.
Qualitymindsetand can prioritize your work in a fast paced and changing environment.
Results- and goal-orientation and committed to contributing to the overall success of Genmab.


Where you will work

This role is based in Genmab's office in Princeton, NJ USA and is hybrid.

For US based candidates, the proposed salary band for this position is as follows:

$48,750.00---$81,250.00

The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as bonuses.

About You
You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
You are a generous collaborator who can work in teams with diverse backgrounds
You are determined to do and be your best and take pride in enabling the best work of others on the team
You are not afraid to grapple with the unknown and be innovative
You have experience working in a fast-growing, dynamic company (or a strong desire to)
You work hard and are not afraid to have a little fun while you do so


Locations

Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you're in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.

About Genmab

Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20 strategic...

Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity